Offering Catalogue

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What we oOFFERING CATALOGUE 2010 -2011


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What we o


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AFGHANISTAN. Basic health concerns likeacute respiratory infections and diarrhoeal diseases

cause around 40% of childhood deaths.


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INTROdUCTION 5

Welcome to NNE Pharmaplans frst issue

o What we do a catalogue about how

we help our customers improve peoples

lives around the world.

Our reason or being is Engineering or a

healthier worl. We cannot claim to save

lives or cure iseases. We o not prouce any

meicine, but we put all our engineering an

consulting capabilities behin the companies

that o our customers. An by supporting

our customers, we play our part.

Our customers work with us because we are

born out o their inustry. Over the past 80 years

we have matche technical knowlege with

inustry experience an worke out simple or

complex solutions accoring to our customers

nees.

We trust you will be inspire an n numerous

examples o how we can help aress many

o the challenges our customers ace in everyay

working lie.

Thats what we o!

Best regars

Hans Ole Voigt, CEO


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Content

9 Engineering or a healthier worl

12 develop, establish, improve

13 Oering map

Part I Segments and oerings

17 Biopharmaceuticals

18 Biotech

26 Sterile & aseptic

37 Vaccines

45 Pharmaceuticals

46 Active pharmaceutical ingreients

52 Oral soli osage59 Meical evices

60 Meical evices an rug elivery systems

67 Inustrial biotech

74 GMP compliance

84 Sustainability & environment

92 Containment & cleanroom

100 Logistics an acility layout

108 Laboratories

114 Manuacturing inormation systems

120 Perormance an organisation

Part II Working with us130 A healthy ecision platorm

132 Fast an fexible projects

134 Intelligent revamps

136 Reliable execution

138 Ecient sourcing

140 Pure knowlege

143 NNE Pharmaplan oces

144 Extene content

146 Keywor inex, categorise

148 Keywor inex, alphabetise

Content


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Todays surgical patient faces a numberof risks including medical errors, aggressive

bacterial infections and after-surgery complica-tions like haemorrhaging and pains.


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INTROdUCTION 9

Engineering or a healthier worl

With global reach and local knowledge and

an emphasis on being close to our custom-

ers, NNE Pharmaplan delivers tailored

solutions based on the idea o engineering

or a healthier world.

Through new an innovative proucts, the

pharma an biotech inustries make the worl

a healthier place.

At NNE Pharmaplan, we ocus on the pharma

an biotech inustries, an our mission is tocontribute to a healthier worl through the

services we eliver to our customers. When we

eliver consultancy or projects, we help bringing

proucts aster to market, ecreasing the overall

cost o prouction an ensuring patient saety.

We share our customers commitment to

improving the lives o patients everywhere.

An as the pharmaceutical inustry evolves, it

constantly evelops new proucts, technologies

an business practices. We take prie in staying

on top o these issues:

We are eicate to the inustry more

than 97 percent o our revenue comes

rom pharma an biotech companies We are eicate to our customers more

than 80 percent o our turnover is repeat

business We are close to our customers globally,

locally an oten on site We play a major role an are very active in

proessional societies or the pharmaceutical

inustry, such as ISPE, PdA, ECA an others Most importantly, we are committe to help-

ing our customers realise successul projects

Listening to our customers

We aim at unerstaning our customer at all

levels to ensure our overall strategic evelopment

matches yours an that our services meet your

business rivers an not just our contract. We aim

to proactively learn about the process, conitions

an user requirements or your iniviual projects

an we listen to your irections an eeback in

close, aily ialogue uring projects.

We are not perect, but we are always striving

to increase our knowlege an awareness. So,i you ever eel that were not living up to these

goals, please tell us we will listen.

Customer satisaction

We measure customer satisaction on nearly

all projects an we set very ambitious targets.

In act, customer satisaction is a manatory KPI

in all NNE Pharmaplan units, an its measure

an reporte on a monthly basis to our Executive

Management. Our customer satisaction meas-

urements inclue cooperation, elivery anproessional quality.

Long-term relationships

We buil customer relationships that go ar

beyon the iniviual project. Establishing an

on-going ialogue with our customers is more

important than winning a new project. We value

the small projects that make our customers

aily lie easier just as much as we like the large

greenel projects.

We wish to maintain a strong relationship with

the iniviuals who are working with our solu-

tions an we eneavour to ensure a globally

consistent approach no matter where in the

worl you work with NNE Pharmaplan.


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10 INTROdUCTION

Project references

Boston(Cambridge)

Cork(Kinsale)

Research Triangle Park(Morrisville)

Chartres

BaselVevey

Philadelphia(Berwyn)

San Francisco

Lyon

CopenhaKalundb

HilleHjr

Offices


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INTROdUCTION 11

Turku

Uppsala

Moscow

Tianjin

Kuala Lumpur(Selangor)

Bangalore

NoidaNew Delhi

Mumbai

Frankfurt(Bad Homburg)

MarburgUlm

Stockholm(Sollentuna)Malm

Shanghai

Guangzhou


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12 INTROdUCTION

develop, establish, improve

NNE Pharmaplans expert consultancy and

engineering services can help you maintain

optimal production processes.

The aily lie in pharmaceutical prouction

is both interesting an challenging: do you

establish the capacity yourselves or buy it? Or

o you contract prouction or evelopment? At

what scale o you work? do you invest or the

long haul or wish to minimise the immeiate

spening? What technologies o you eploy?

Are there new opportunities that you shoulconsier? In short, how o you implement your

business strategy o toay or tomorrow?

Very ew operational acilities stay as they

were esigne an built. With the operational

experience comes the possibility o continuous

improvements. New prouction technologies or

prouct evelopments open up or urther opti-

misation aressing the ierent bottlenecks

in the prouction. Mergers, consoliations,

expansions, prouct transer, contract manuac-

turing, regulatory actions or new regulations areall examples o changing conitions that require

aaptations to new proucts or processes.

The product and the process

The ocus o all these eorts is to ensure an

maintain optimal prouction processes. NNE

Pharmaplan ocuses not only on the general

engineering processes involve but also on the

particular technologies an business conitions o

each segment. We know the ierences be-

tween the various pharma an biotech segments

an their proucts an processes an buil our

services on broa prouct an process know-how

an experience.

Supporting unctions

Yet, pharmaceutical prouction is not only about

proucts an processes. The supporting unctions

have to be in goo shape as well. Compliance

an sustainability are critical actors requiringspecial attention, critical utilities, environmental

measures, saety, logistics, quality control an

inormation systems. An last, but not least, the

organisation an the people are vital.

Oering map

Our oering map to the right gives an overview

o all our els o expertise process as well as

supporting unctions. The oering map presents

our core oerings. We have eicate specialists

in each el an up to ate know-how as well

as vast experience to base our solutions on.

In the ollowing chapters, we aress core chal-

lenges in each o these areas an show how NNE

Pharmaplan can contribute to the evelopment,

establishment an improvement o your prouct

manuacturing.


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Oering map

NNE Pharmaplan at a glance

Over 80 years o experience in the pharma an biotech inustries More than25 global locations in Europe, North America an Asia Workorce: More than 1600 Turnover: dKK 1,488 million/EUR 200 million/USd 266 million ISO 9001 certie globally


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INTROdUCTION 13

... and or the entire manuacturing lie cycle

develop an optimalapproach to achieve

the require prouctioncapabilities

Augment theeciency an qualityo ongoing operationthrough optimisation

an support

design an establishacilities all the way

to ecient ancompliant service

Develop ImproveEstablish

Biopharma-ceuticals

VaccinesPharma-ceuticals

Medicaldevices

Industrialbiotech

Oerings or all pharma/biotech segments

Biotech VaccinesActive

pharmaceuticalingreients

Oral soli osageSterile & aseptic

GMP compliance

Sustainability & environment

Containment & cleanroom

Logistics an acility esign

Laboratories

Manuacturing inormation systems

Perormance an organisation

Inustrialbiotech

Meical evicesan rug

elivery systems


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Our service philosophy

Passionate and committed to working in your industry

Valuable insight Consistent and ast execution Superior outcomes

We deliver

Highlights

Fast track Multiprouct revampsRisk-base approachan quality by esign

Turnkey acilities IV, vaccines

Single-use technology Automation an IT

Cost-eective operationan acilities

Personalise rugsan treatment

ASTM E2500 verication

A wealth o specifc services to implement our oerings

Studies Feasibility analyses Conceptual esigns Master plans

Ramp-up Prouction ramp-up Training Process valiation,

cleaning valiation

Support services Sourcing Cleanroom testing Troubleshooting Revaliation Specialist staff

Strategies Supply chain manufacturing Automation Single use Quality by esign Site selection

Facility projects Programme management Engineering, basic esign, etaile

esign Architecture Automation Construction management Commissioning Quality Risk management

Upgrades Compliance gap analysis

& assessment New proucts an

technologies debottlenecking Automation upgraes Fast upgraes with minimal

interruption

Analyses Technology transfer Manufacturing sciences development support design for manufacturing

Solutions Automation an IT solutions Cleanrooms Turnkey facilities Process moules

Operational excellence Process optimisation Output, uptime an cost

improvements Lean & Six Sigma Change management Leaership an people

evelopment Continuous improvement

methos

Develop Establish Improve


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Part I Segments an oerings


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USA. The number of people with haemophiliain the United States is estimated at 20,000.About 400 babies, mostly males, are born

with haemophilia each year.


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Biopharmaceuticals 17

B

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pse tfas caenges. At NNE

Paapan, e see a de aay f

ne and nteestng pptntes.

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by b bn n q n

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b b. an n

n g n g

nng w ng- ngy.

B n ng w

bn n bn

x g y.


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18 Biotech

B

Cst effecte pdctty s aays a tp

pty, and ete t eqes estabs-

ent f ne factes peent f

estng pdctn, NNE Paapan can

dee te pt stn.

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b w.

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o y, NNe pn bn n

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nn n y bk-

g ng n gn n y,

ngnng n ngn , NNe

pn nn nn n

n .


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Biotech 19

NNe pharmaplaN services Featured iN this chapter:

Gettng a g tgpt deepent facty at cst

Bdng ess byng

Deeng g staes eap

Febe, fast, da

Get stategc t snge-se tecnges

Net geneatn btec factes

Snge-se tecngy catage

Yed nceases ceate ne bttenecs

200 pecent ncease tg bpcess ptsatn

Atated appa f catgapy ns

Pasa factnatn

Caenges n adanced teapy factes

Pef eape f den da

engneeng and desgnt ny Nsn y w

b n wng : dgn -k

m n nn n -ng

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t y w n ng 28 nng

nnn.

t nn-b jgng n

Nsn n wnn

n: c gn wn

-k n j xn, -

n ngnng g n

n fxby, n n ng

g y.

t n nw ng N Nk

wy n bkg n -

n , w nng nn y nn .

Gndbeang pant eceed

te Facty f te Yea Aad 2005

Wn N Nk b nw

y n -

n, ny n NNe

pn nn

gn n ngnng. t n n

b n ng y n

nn, y n n.

Denstatng gba eadesp

t y w b -k j n 18

n ng ngnng nngn nn n-

nn n - ng

. t w gn-

bkng y n ng-

nng w n

n ny.

on y w , n b

n g Fy

Y aw. t w gn -

n w y j

n gb gng-g ngnng, nn nw

ngy n n xng

ngy.


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20 Biotech

BuilDiNG vErSuS BuYiNG

Bngng b k q nn w b by nngy. t n n n bng y ng b- ny nn b n n b. ow,y n k n ng ny k ny. on n, g nn y n n n. t n by y cn mnng ognn(cmo) w n n k ny. tn y b

g y nn.

t bng byng nw n n y ny w ng n n n n.B n n by -ky j, w nn bng n(w b n) n n -n w -n, w- nn b n b n

GETTiNG A hiGh ThrouGhPuTDEvEloPmENT FACiliTY AT lowCoST

W ny wk w n nn xn n y.t w ng b -ng n wn n bgn y xn y bkb b g. o wn g g- n y

w b. B n n n n, bng n byngn n g n w n.

o n, n w ybw byng y w y gy n b

. W n nn, y, wkfw n 3d ng-n n

.

sng- ngy b n-g gy b n-g n n n n n n nn. in gn n, w nn3d ngn ngng w n g w b n y.

a g ng-ngy n, b w g g g n -y b n -w w n n .t bn n j g , y, q nnn w nn n n .

n g g ny n bng n yw n n . in wy bn n gy n w n-n w nng n n yy k ny w byn n .

gwng nb j k n n . a nwn y w ,

b bg w , g n n gnn, xnn b n n bng n .

W wk w , n nn g gn -ngy nn y- n n-


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Biotech 21

FlExiBlE, FAST, moDulAr

a NNe pn, w ky n- -k n ngn-ng. a g x nkyy w b n my. t y, n- n b , n -b nn nn nb.

W gn n n qn .on wg fxby wn b b gw ng k nny n. an qn wGmp-n nbng nnn n n

n gby. s wn n - qn ny n e n n nn-n b ng my.in n, y , w NNe pn bynng y n wnx y.

sn y n x ny qn b, n ng

w nn y n j n ny n.

ty, y fg.i b my Gmp-nb y n k n ny b .

DElivEriNG hiGh STAkES rEvAmP

Wn n n y n n - bng ng- y - n y, y k NNe pn gn, ngnn ng n j. tj n-, y xnn n nwn n n ny 100 ngn.

t n y- n w nfxb n xng n n g b wn n-n. s k w kng yn. B j w xy nng,cnng n sn n p (cip, sip)n n qn. an nwgn n f xn xng n n - .

o w ny n x j xn n n w ny

ng. t w -ng nb ng ny n n . a j g, b w b n n n n-n y. an gw n n y g n-y bk n n yy w n ng n .

an , gn nb y n n n x n. in n 18,000 w n 800 nn w n ng w qn. W xn by 50 n - nn xy , ww b j n nn bg w 550,000 n- wk.


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22 Biotech

NExT GENErATioNBioTECh FACiliTiES

Wn y nnng n nw b- , y n bn k, n n w :

dng w b nw y g n xng n

ang fxby ebng y gn

n mng Gmp qn b b

n xng inng ngng

nn n ynn

GET STrATEGiC wiThSiNGlE-uSE TEChNoloGiES

sng- ngy n k -n b n. tng ny. inn n -b n ny bn, b y n ny n gy n n nn ngy.

o n n ng- n n n- -n ng n n ny, n g nny nby ng- . W qy, y, ny y gn, xnw wy b n nn n - w bn ny nn.

sng- ngy n nw n-n nn -by, b/xb, n,

bk- , w ngn n n n Qa y xn n ny w - b n ngy. a NNepn, g g g ng- ngyw y nw n g g. an w bn y ny n bn nn nn y nng n.

W n qky ngb n ngnng .By ng gn n

nn n-g qn n ng- ngy w b n ng ng- ngy n y b

40

35

30

25

20

15

10

5

00 20 40

% Single-use process modules

Project-specific trend curve

%C

ostreductionrelativetotraditional

60 80 100

. Y n n n qky ng nngn. t y n g y 360 n ng-ngy n y , hvac, qn, n -n w gng g n y n .

F n n nw gnmab y, w nn y b n n n w w n fw n n n, -n j-n- n ng-bg, nk by g--w n . t w ygn b n ln wkfw g n n -n n g, n n ngng n n gg-n bwn , n.

in n , gy yn b g n n wn ng nn nw in

3d bgn n n n-qn w nng y n. t n gnkg n n ng, y, wk fw n ny n ng xng y.W bn n n b n ng 10-20 n n n b n n gwk fw.


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Biotech 23

SiNGlE-uSE TEChNoloGYCATAloGuE

in k w nw nnw nn qny , ngy -n ny n n bjn. a NNe pn, ngynn x n n-nxn w ng k g, w nn n n n ng n nw n , xn n g nn, gg n n nb n .

s gng- ngy n b n ngy g, n w n ng. Wnn xn n n

g nn bnw n. By wk,w w k y g n ngy/ bnn. tg,w n ng

YiElD iNCrEASES CrEATENEw BoTTlENECkS

Y n nw g- mab - n n xng y. B y yw gn n b gy n g y. a-n n n, n nb n g ngnny n y nw wn bnk n y mab y. W y ?

i y nw bn nw w w ng y, g x yy. i n b ng - n y wb ng , w ng

nn n y by - , y nknwn . tb n y w ky n b nn, n y .

in n g y j, w wk nn-y w w w ng y ng. B y y bng w yn, nng n nn n n y w y

wn gn jbw bng x w nn n n. o ngnng g fxby y g bk n n- gy n y nbnn w g- w ng j ng y y.

n. s w fxb-y y b n n b ky n n n nn y nn.

a wn wkn, w n ngn y gn n n w

ng n n . F , w n ng y ny n w b n nn.


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24 Biotech

200 PErCENT iNCrEASEThrouGh BioProCESSoPTimiSATioN

Wn bng gn b y,y ny n ng n y gn n. t n n n y xng n y-, y y wny n y y ny j ng.

a n y nnw nw y bng ngnn b, ng n nn b y j. t xy w b y n ngn y, nn , gy cip n -n w n g nnb y n y . tn y n y y nbng b n n n. B qky ng w-n w

AuTomATED APProvAl oFChromAToGrAPhY ruNS

pn b byn gy ky n nng ny b-. B bj n gn n n nb g, n , ng, kngny, . a NNe pn, w g xn w gn n n gy n n Gmp ng. a gn, n, nn nqn qn, w n gn n n n n

b xn y n.

in n j, n n n n w n y nn n n n nb n- b n 24/7, g- n.ty wn x b gn n k. o nx w n nng n g w

bnk, n n nqn nn y j.

o 20 y, w

100 y ny -. ty bx n n- n w Bn sp/sp, b knwg n y nnng . W nny ng bx y b ng : B z n ng n b-b

k n y y n n w nn w ny ny n xn.

in , w g g gny n n ny g-y n n n ng.t g n y n byng n 20 gnn gy -y ny nn fw, n , kng k nnn .

t nn gy n n y n n n n n y n ny. an n . s gyn n n n n b n n b gn n g n n g n gnnn.

B xn nng nng y gy

o g tnk z B nn uy nn cip qn

W g , y j nn y by n 200 nn y xng bng . o -n j n-n ng 29 n.

1800

1600

1400

1200

1000

800

600

400

200

0

2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Year

Capacity and production need Capacity and production need

kgp

roduct

kgp

roduct

1800

1600

1400

1200

1000

800

600

400

200

0

2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Year

Capacity Ferm 1 Line 2 Large productCapacity Ferm 1 Line 1 Medium productCapacity Ferm 2 Line 1 Small product


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Biotech 25

PlASmA FrACTioNATioN

B nn n n n

nng : n n n , gwng n, n by, n w -bnn , n y, n xgn ng n b nn gn.

mnng n by b nn q ny -n n . t k -y xnn b n n . a NNe pn, w gn xn x wkngw 70 n ng nwn b nn ny.

a n x, w j nn n wwn b n -y by xnng n xng bng. ongn wk w y ng j gn g n ny bg n .

t j bk w gn n n ngn - w ng- ngy n n-nn nn b n -, -n .

in y, w wkng nn by ng nn nng nn n. By ng nwn ngy gy, - w b gnny n ny j n y g n j n.

ChAllENGES iN ADvANCEDThErAPY FACiliTiES

an n n xngnw gn n b. a gn n wy bkbg n g, gny, y n ngnngn b n b w wn .i n k, b nb ng. t nn : yy n y xn n gnn n

nn n y bn n. png n w , nn n b , b ng. an n-ng b g b y w n b nb n gby, y y n nng y .

a NNe pn, w wk n nb j wn n y w n y

b. Wn n n s K nw n y y,y k b n xn ngy n- n Gmp n.

t y gnn g n n g. tg y wk by ng n wn n n y n nng g wn n ny .

tg wk, w y gn k n n qn qyn bn n yn . on qn kn y n--n nnn. s w fxb n n10 n ( B) n j n by n 30 -n n bqn xnn .


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26 Sterile & aSeptic

S & s

Asepic an seie pocessing is compe,

boh in ems o echnoog an eguao

equiemens. We can hep ou ieni

he bes souion, aing ino accoun a

eean aspecs.

connon s k n wo o n-

s g os s ox n ngng.

as nng s ssn o ngy o

os n vs.

as nng so s y o ox-y o oon osss

o oon n on n

o s n s n onn. tony

s s bn on n onvnon noo,

b oy nb o noogs v-

b (soo, raBS (s ss b

syss), sng-s syss n s ns

o s) o ns g sy ss-

n v (Sal). in nson , vson

sys nqs nb nsy

o v g ovy n g o

qy.

O ss n oss, nng bng

n kgng, so ngong -

vons. F by on ons,

bng n by qns on

s. an non o n ogs-

s syss, nng o g v-

s (aGV) n o woss, sn

nw ngs o ng oon o

s n s o noogy.

a NNe pn, w v nsg no

s n s n ns osss. tsns o s-n xn ong

n s nvonns, xnsv knowg

o goy vons, x-

n ngng n noogs n

wnss o nsys os n vo-

ns. W n vs yo on x o -

noogs ks os sns nny

o yo ony. an w n yo bn

yo nvsn oss, oon oss, g-

oy qns n sks.


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Sterile & aSeptic 27

NNe pharmaplaN SerViceS Featured iN thiS chapter:

High-ech asepic acii heps mee eguaions an sae coss

EU GMP pushes he use o echnoog

Fining he igh conac manuacues

Inusion souions wowie

Opimise omuaion eies capaci incease

Compei in eee ing

Fu-scae eie o eee ing isoao ine

Wash an seiisaion an inega pa o asepic opeaions

Campaign fing a moe efcien wa

Pacaging chaenges

Inspecion echnoogies

Fighing couneei ugs

Micoosing a new siiconisaion echnoog

Inena ogisics an maeia haning

Conaminaion fning he oo cause

Singe-use in fing opeaions: he uue?

Opeaiona eceence in esign ecognise

in 2009, n s s oon

n sgn by NNe pn ws w-

sgos nnon iSpe Fy o

Y aw n Oon exn

goy.

Fo o n 50 ys Gn ony

n s bn ss on

n o n soons n ss-

nsons. n s vs nvov

nng n kng o q -

s, y o oss n nnsvn.

New seie poucion pan

NNe pn n sb-

s 9,200 s oon n

won w o oon xn. W

bo ngnng n onson ss,

n on NNe pn n

o o s qon on, on

sk nyss n von s

n. NNe pn ws so sonsb ovwng n wokng on sgn,

bs sgn, oss ngnng n q-

on.

t w jy gg ys ln

oon ons, w w n

ogo sgn n onson o s

y. Fo x, u-s s o

ng syss n g-

s ss o noo, nsng ns

ovy.

Signifcan incease poucion capaci

t nnovv, fxb s y ws b

n no oon oj o

ony 25 ons n s -

qs n hn, Gny. t y s

ns onys oon y

sgnny n s o -

non o nnovv noogs.


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FINdING tHE rIGHtCONtrACt MANUFACtUrErS

invsng n yo own ng n kgngy y b osy wy o oyo n o. in nb o sons,on nng s b oon.

NNe pn n sos so n sn on nng o-gnsons (cmO), n vs son son oss. Bs on o nyys o xn n nbo nss, o gob sn, osnon n nos sso-ons n s o sos o ov wo, w v vs nwok o nsyxs n ons n nsy. in -on o s, w v nb o bbs sos o w on.

W on cmO s o n ony n o x o yo n. mny sos w vvy s qns o cmO.c on n n o onqns, n ngg-onsons o w ons v -ov cmO.

Bs on s w w sn ns o yo, onng o sngs n wknsss, n kng s sy s ossb o yo o k bso.

W so b o ng vss no s o s cmO o vy s n on w n Goomnng p. O os oo bkgon o goy o-s s s iSO n Fda, n son o w xn o wokng nqy n oon.

a n cmO son, w o o yo w on ngoon o ns

yo g bs ossb onons o o-boon w cmO.EU GMP PUSHES tHEUSE OF tECHNOlOGy

t eu Gmps nw annx i, mno S mn pos, sssn oss o z yng.t gons q z- vs osy n g a onons n n osng gvng s o on ssonsn oo nvnons sss s w s

HIGH-tECH ASEPtIC FACIlItyHElPS MEEt rEGUlAtIONS ANdSAvE COStS

inng on n ns ossng y qs vnknowg o vb noogs nng bns n s sw s oog nsnng o gons govn nsy. tsks bnng non on gons w nw noogvons ky ng.

in s-o--, g-s s ns oj n Jn w ov g-oy n noog know-ow o s-o o ns g o o ossnoogy.

Bs nw ns n w sbos o wo k, soy bo w eon, uS n J-ns gons. B so n

on ng: y o n vyov k n so n ojws os-vn.

W so oos bsvb noogs, nng sngrs ass Bs (raBS) noogyov soos wv ossb. ts sn sgnn nvsn svngs. in on,w sgn fows o v g ng v n ooo s n s son sow o n ngy-n y y onhVac nson.

On s sons bn , w o on, bs n sgn n w sonsb o ovoj ngn, nng nsn oss oon. W so n-g bo onson n sgnqon. a oon o y,w so so w s- noson svs.

onns o nvonn, onongn v ngy ssn.

a s ns yo n o ons yonoogy y: is soo noogynssy? W s ss bs(raBS) b sn? do yo n o o- ong n nong o zys? an ow w n soons yo nvsn n oon oss?


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INFUSION SOlUtIONSWOrldWIdE

t nng o osns g sns wn nnng o-on s. evn sbs ons n bn o n xn,b n.

NNe pn s o o n40 ns o nng o n-son soons n o n 30 onswow nng noogy nso sn soons.

O xs ns ns o n-ng o nson soons n ng novos os o y kgng s sgss bos, s bgs n bos (bow s noogy) ngng o 100 o 1000 , o pVc n oyon bgs ogon soons o 5,000 .

OPtIMISEd FOrMUlAtIONdElIvErS CAPACIty INCrEASE

an ng n o oon n b ky o g og nonssn qy. dsgnng n ns-ng syss n n vssbsns n ons w y,by n wo nons qss knowg n oog o-ss nsnng o ons o ss own n nsy o y syss.

W o o sos xnsv know-ow n nson nng noogy,nng:

t gnon n sbon o wo njon (WFi)

Soon on n sog mnng bos o bgs Fng bos o bgs Sson o os inson n kgng

W so ov oon ns (sn- ong os) n qy onons s w s nng o s s n. an w bo snnson n s xn soons nn non soons (nng sons).

t oxy o oon n ngnks s y o n sys

o s ng s o n o nks n g nb o vvs, on-nons, sng ons, . so o nk sys. consqny,nng-n- (cip) n sson-n- (Sip) o nks sy o-n o y o oonoss o n vy -onsng. in , sn on cip/Sip ns n y son o ony 30-40 n o os oons. Oson oons n o

fxb sys w ob nks n o-ncip/Sip, w s sys s o.

d o bov son s, ons on on ooko o soons n ov ny o obn sob ng-ov o os ogoos so (cOGS). to NNe pn, bss o oson s fxby, oogoss nsnng n nsy-sxn. W n ng yo o-on s, qn o n fow no o v o fxb n noon s.

Fo sos w ny n o-s n b szs, w v noofxb syss w ob nks nb kn n n o o oss nn n ss wy o osso n oon o sw o nks. cons w now

o ng w on bn o ong syss os w nbo nks s o oonn. S syss n so v ngo n/o b ono. a NNepn, w v n gyo syss w ng ono, w kng, b o-ng n vn ng qsono n n-oss onos k h, n os.

O ojs ng o s-n og-g oon n o svso oss ngnng o syo o n on nky bss.


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WASH ANd StErIlISAtION AN INtEGrAl PArt OF ASEPtICOPErAtIONS

Fo ons n ossnvov n s n s oon,ws n sson s onsng os v o q-ns o g qy n sy. hvng g qn o yo ns n n w yo xsng oss qn s onson o ny ws n ssonoss.

Ws n sson qn nswsng ns, ovs n osossng qn (cpe). as oos owsng ns n ovs, cpe nb s n non w soo ngnoogy o oss s, bb so-s, ons n gss bs n y ono soo ng ns sngs onns wo bkng css a s nvonn.

a NNe pn, w xn nsgnng n sbsng ws n s-son n o ns o v ngns (api) n soon. W os on oonbwn ws n sson n ooon osss s s ng, qyssn n y s, w ss wok o w o ons n wo ok o n o o v bs soonossb.

FUll-SCAlE dElIvEry OF FrEEzEdryING ISOlAtOr lINE

a on o o sos s, zy s onn o n soo ng n.to k vs n soo nvonn, vs nso n o no z y by n o o sys.t o ong sys s b o o n z y s by s n on-

o nvonn svs by Scada(Svsoy cono n d aqson)sys. W wok w so o o sgn n nonsons.

a ssby vno s, n-ons w s n qn wss o sos s. d o nng n bng onson, qn ws ow og oo no oon . t wg o

COMPlExIty IN FrEEzE dryING

Fz yng s on o os oxosss n n bo- oon, n oss nosnoog n goy ngs ons. tnoogy, osss ng bs ny z s oos o ns

o nson ws o n 30onns. in o o os s n noo , n nsonsn onns w on foobow b n nnn wss ov o oon .

Wn z yng y s o, b s oy by nong sys onsss o

on s b n foo. t ny n n v kg ( s sz) . t vs ov o b ko ns s nong. Fo y oy nso o nn kn o ow ss .

t n nson ws ng,nn n s by NNe pn,n w ns nssy qononon o qn.

w vb o nb zng nyng bvos.

a NNe pn, w v o n25 ys o xn w z yngojs, o s sz o ns (n-ng q nogn oong syss) o g-s oon ns w y oono o ys, nng cnng nSson n p (cip/Sip) n ss.W v os on nns, qy n goy sss, n wobo w ng ss o zys. Ss v ng sn oj ooon, w qy nxs onsny ssss.

O objv s o v ng so-

ons n know-ow n o o n yoo soon s ssnb nnss s o k.


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n y nyss, sono b son vs n os/bn n sk nyss.

3. t non s n w gn o ws v w s o on sy n gn.

4. t von s. Bs on -ons, oss ws sgn o - svn n ys o gn-ng o oy w sos goo 20 n ns n y, ns go ws wn sx onso oon. aongy, sx ons non nw gosw s o oon. ts nvovnsng gn ng oo svn n o 21 ys. tsws n ov os o oowng wo ons. toy, yns soo o 21 ys wo

onng . ts s s n o -y ns o o n 30 n.

Ov, oj ws g sss o so. i n o o b ow-osoj (o onsn os n oss oony ys o oon o ) y vy g ns n y,so ybk ws vy so. F-o, sk ws vy ow o son (ng/sson o w s)bwn bs.

o ng n bn ong ony onb onnon o soo.

t ng n n soo bn o o 2006, w s nsv ovns n vy sbon. B o o ws s snon b ng-ov. Bwn vy b, soo ws onn n ng sys ws n n ss n (cip/Sip). e b ng-ov ookbwn 24 n 30 os.

Bs on s, so nsss o oj: insng o Ov eqn e-

ny (Oee) o soo ng n rng cos o So Goos (cOSG) usng soo ng n s n soo

n no s onvnon noo

W g w oss sss o

y o oj, w ws v noo ss:

1. t s w ojs objvs n s o ov-n.

2. t nyss s w nsng n n bng-ov w o b o olgo boks o vss ng n n soo. ts s so

CAMPAIGN FIllING A MOrE EFFICIENt WAy

Fo ny ons, ks ong ov bwn bs s bonkn oon oss. mos o os bwn bs s o nng,w s ox n -onsng.howv, yo n sv sng gnng.

W gn ng, yo n on on b bwn ssson o nng/onnon. an bwnbs n gn, so nng n b o.

t gn o sns sgn-n oony o ns oss onon-oon vs s s n-ng, sson n n ssby.uy, gn ng n ns nb o bs o y,n s ns yo nn oony.

reguao equiemenaog gn o s nowbong oon n s o-sss, s s k o y bo wgoy os n x ns o von.

So ons, owv, qny s-ss n goy gs n n y xons o n g-oy os. t Fda g, S dgpos po by as possng,ons Fos sso w ongs n on ossngn n os onnon sk ss ng ogn, Wn o, s sob sbs o s o sossng, n s s So bso by .

eu Gmp (annx i) sy ss, tnv bwn sson n so oonns, onns n qnso b ns n sbj o - o o sog onons.

Successu campaignfing impemenaionin 2006, NNe pn ngn ng n n soo o n snng ony. Fo sx ys y bn n oon, so-


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PACkAGING CHAllENGES

t joy o obs on kgng ns

o oo n n, so son o sgn gss sss. dsgn onsons o nyo so n by o ngqk ng-ov, o n nbwn o bs n n nn n sy n ono nn.

a NNe pn, w v onos yo ss o bo nw nxsng kgng s. in nyss, w n so kgngoonn von n sggs o-s soons n ss. By sng lnnng ons n kgng, w n os yo nnngoon.

Bs o o ny ys o xn n nsy, NNe pn s oogknowg o n kgng -n ovs bo n s o noog- bs n by o nsg ny vs. aongy, wn yo oos ov n qn w bs s yo soon.

W n so yo oos g k-gng o yo oon oss,kgng n n qn, o w n

js yo kgng n o n w yoo n kgng . O w wok w yo on son, n-son n qon o yo kgngqn n osss.

NNe pn so os bo ngo o ngnng n onsng svs o kgng, o x:

lbng n ong on y, son-y n y kgng s ns

Bs kgng o bs, vs, vsn ov kgng

conng n n, n o o fow wn o kng, won nws

cs kng n s boxs o bksns

psng ng o sn-on ts n von noogy nvov

n bov non osss inn o nng, bs, obos

n nso syss pkgng o g ony gs

INSPECtION tECHNOlOGIES

in n bo nng,n y n gs o ns,nson s o nsng ns os s n sy nv o vn qy n sy q-ns. consqny, nson s sbjo nsngy g goy qnso qy. a s nson oss s

ky o nsng qy, b s so o nsng g og. too snson y w o os y ssoy n o so nob s. S s js o no n nov s ow n o b.

NNe pn s xn wn w ng o os (ssnsons, so-

ons, yos) n onns (gs,vs, syngs, os) s w s n-os nson noogs.

O xn ns y ovs nson ns, b nsons,k on (ns o vs nsonso s n ks), os nsonssng g vog, v o snyss, kng o n (v) ss-

bs, OcV (o von) ob ns n ng/kng o x os o vn on os.

W o ny ys o nson no-ogy xn, NNe pn s w n ss o ny n no v on w ovs o oos.W so oon wn oso nw nson noogs, so w nov yo w onsng on on sw s nnovv soons.


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FIGHtING COUNtErFEIt drUGS

Fk gs y n

n bo nss. con ns on vyw n wo, n s oon n vo ons s y n vong ons. ty so xson nn w onss, n goo, ook o s o gsy g no ows b b o o.conng os s -bon o nsy n, y,sos os on o n osns o on gs nn os on nn. in , v n 2007sow n ns o ny 400 no o 2005/2006.

t s o on gs s gowng: n hiV ns, n,n-ssvs, n, og nn o. evn ow-os gn gs nvs n ow-nng sgn sbj o on.

Bogs os ng o no xso ox sbsns o nv,nv ons. ty n s nn , sv sbn, ogn n vn . So onn -, v ngn n ook so so gnn o y v ossons s w s ns. Bn vy s, so s nknown n sonn nb.

enng on gs s ons-b b ng. Nosons y v ws n o yn so o oon n oo on gs, n os,s, sbos n ss os obong on n-on nvs o ono ob.

t vs o on gs , s noos, onss, b so n

bo ons s n on-ng, w s g o bsnssn k. moov, s og-no o o, n sn obvos o o y n o n-on n sy n ono os.

t soon s o k n ossy vb, w so ks s ony k os. mny - ons v vsb sys o kgng. ts n

oogs, bossng, s nk nwo-nson b os. howv, svsb s no ony ov n

sy, y so q n sonno y o non.

mny ons s bos o n-y v kgng bs y w noogy, n bsbos nxnsv o n n y.howv, wn bo s -ns o os kgng, nnob s o ny on osbs y o no ov vnon n ssb o syoon.

mo sos noogs v bn

vo o sy nng nnon. t oon bss o snoogs s o y nq n-on o o nv k, w wb k by s bn on bo snsng o o so. i ss snn n-s o, w gg n ,n s n n nvsgon no so o on o.

ao inons, o ao ids, ys o non ns n, n y n:

Bos two-nson os ro qny non (rFid) gs O c rognon (Ocr)

e y s nb o sb-ys, w v os n ons, vng yo w vs nb o oons n -son o k.

W n yo oos noogy bs s yo ns. W n so yo sgn n nson o k s s y ng w yo oonn. W o oowok o yo gs n bng yo -o-s w o soon.

as w s n v s gnson gs, on nonnoogs sn nb o obns: aon o on gs, s-

y n ngn, vs ogssn nvnoy ono

assn noon s o-y n oy vy

lss nny s noon n bs n n s

lss onoonos n ngy gsonwok

esy k-n- o o s-ns


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MICrOdOSING A NEWSIlICONISAtION tECHNOlOGy

mons o ns ov wo yon y s-njons. ts no ony ks nn on g qy n,b so on sy-o-s s-njon vs nb sy, ono nson.ts qs n vn on bwn ng n gss s ovs og onn.

t on o son o on ns o gss s . i -ns v o ssn n onn,n s onos ow sy o s ov n y njon v. tson ong nss n yng o onn n ns osg osn ws, so ovng sonson s kyo ovng o.

rny, nw sonson noogy o-osng s o no y.

mo-osng nvovs syng son on ns o gss, b n s s synozz s og n ng o

gss n js syng o boo. ts ks y o son on gss ws o no, w so vn on on gss. in ono o oognos sonson, o-osng so s bn o ow ossvon, w s o o onssno qy n os o-n w goy qns.

in on o o ojs w n sonson sys bs on oosng.t so wn o xs-ng sy sonson sys o gsn o o v:

mo oognos g sonson r oss von Fw jsb s long ong n sson

nn

W on o Qy by dsgn nn, NNe pn sovo, sy, s, ns n v nw sonson sys. W so n sos s o s nw sys.

t oj s n sgnn ossovn n g Oveqn evnss (Oee), s n-nn n ns by.

INtErNAl lOGIStICSANd MAtErIAl HANdlING

t sgn o nn ogss n nng s ox xs nvovsonnng nng osss n wy nss g s g g . ts no onys o nso o s nos o n o oon n bso o v n s osss,sog osss n ws nng.

a NNe pn, w v ny ys oxn n nng n nnogss o Gmp nvonns wn n bo nss. an wo w o ngnng n onsngsvs n n soons wn ss, nng ogss sgn, wosyo, sgn o onvys, son oaGVs n o s.

Wn s oon, w x-n n sson o s sso w n sgn ogss n nso-on syss s oo zonngn vn onnon n nng oss o on ss ono.

Fo on o o sos, w sgn nw s-o ogss soon o kgng y on vs w o-on s on s n son foosn n woss, n v n s- s on gon foo. t sgnoss nb o sos soonss s now-s wos, vonvyos bwn gon foo n son foo, n o sgng b ob s n ws sys.

ano so n oy nwogss on n n xsng bng. Wsgn ogss on s o-ss n ngn, ng ovo wos n xsng w-os, n o so n k non,o -sng n sng,o nso o ssby nkgng ns, aGV nso o s-sby n n onvyo n nsoo kgng ns.


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SINGlE-USE IN FIllINGOPErAtIONS: tHE FUtUrE?

co o on snss soss qn, sng-s qnsgnny s sk o onn-on n so s nvsn, nssfxby n ss o k.mny ons wn nbo nss v bn sng sng-so ys n bo ons. an yov -ns oon, nngsng-s noogy n bo xsng nnw osss n yo s bsnssbns n o v oon.

Ov ys, NNe pn s -sgn ny sng-s syss o on,on n ng o w ng

o sos n n bonss.

in s o on, sng-s no-ogy s sb o b szs s n1,000 s. inng sng-s q-n n on ows sns-ng o ow o b on n os sysn nbs s oon.

in on n ng, sng-s qns oy os sys sng

bgs, s oss n s ongs, n nbs on n ngy ss n-n.ps ng s q, owng so b os g a n ovngxn ng y o s vos.

as w ny noogy, sng-s syssv bo vngs n svngs.t svngs n g n oogss n nng o bgs n os, g os b n s nvon-n .

t ny vngs n: mx fxby Fs ng-ov l nng von (no cip/Sip) No oss-onnon bwn

os

low nvsn os So non

t vngs sons w onssng-s noogy o b noogyo . W v wok on nyojs w sng-s noogy no o b bs o, o x n onson o o bo y nbosy v 2 (BSl2) w -ns bson sng-s n on n bssgn o sng-s oon n ng.

CONtAMINAtION FINdING tHE rOOt CAUSE

evy now n n, nx obso vns o n ny y o oon s n oo o qy. ao-s nsngy o nbo ons sonsb o n-ng n onng oo ss o ss-s n oon.

W n o obs s s sy o onnon s sy o ny,ons on k oos n know-ow q o nvsg so o ob n s n v wy.W o vs oss knowg n ovnos, w n o yo vb son nvsgon o oo ss.

O o s bs on so- roocs anyss (rca). ts s s o ob--sovng os nyng oo ss o obs o vns. rca

s bs on b obs bssov by ng o o o noo ss, s oos o y ssng

obvos syos.

rca ns n oos s s iskw o, o sbon os,w s n nnony ogns qysk ngn oo o snnsy (ich Q9). i n b s vs oo ooks ng o ony oo s, nng:

msn mn (n o) mn mo N (oss nvonn) m mo

r n ng on son n g onvsgng s, NNe p-n ovs oos n song osbj xs. e b

s xs n on o o o s s.as s, oo s nvsgon ss n sys, nsng

xo n .

O rca kg ns woksoso k yo nvov ogo ossn o s ooogy n nngsso yo q o w ng o oog nsnng o oss n ny sks nvov. W w wokosy w yo o vo os -on n ong w os s o non o oo s.

Measurement Man Machine

Mother Nature Material Method

Problem


38/154

RUSSIA. After years of decline,the tuberculosis incidence has doubled during

the 1990s and Russia is now among the 20most affected countries in the world.


39/154

Vaccines 37

V

The hae eoltose theaet

teatmet, bt to tl eaate seases,

aes mst be aalable a aoable

eehee. O mola egeeg

oet s esge to altate ths.

Th o wo o pht ttt

wo b thkb wthot v. Th

goo o toy o how ew J 1796

th obvto tht k typy vo

pox b thy h b xpo to

th owpox y gg o hth wo wh t bt.

it w-kow tth tht pvto

hp th ttt, th who v

b vg xp o wht th y

. i t, v hv hp

pvt o v t b o o

th ogog t otg

o o wo. nw pog v-

vopt tht y ov o

o th h bggt .

Toy, th v ty wth

o , gg o

thogh top pt v-

to pog to v , th

tt gowg gt th pht

ty.

i a yt gg oo,

v o v v ot xy.

shot o HiV , both o whh hv

yt o v, gg oo y

q pt v. i thv w otty, thy o hp

t k o th ot-

t.

Howv, bo th hpp, th p o

th v t b ow thy t b

vb vywh. at nne Php, w

vop o v t, whh w

hp tt th, by povg ot-tv

ttv to g to o.


40/154

38 Vaccines

V

Bl ae maatg s sbjet to

ma halleges a a eelomet

qe to aes. Beg o to o that

eelomet e oe a e age o

sees to mae se o ll be too.

Th poto o bk v vov h-

g tht ot ot

oth pht poto, h gg-

b po, ott boty,

owt po tht ot

xv to v poto.

V poto o th 100 y o

w-tbh thoogy. Howv, -

t y hv t vopt

poto thoog. Fo t,

v poto h gow ty,

th by th g w o

th o p pp. eh

y, th WHO f whh v t

b po. Th pot to b y fv

oth t. i gg th wo o-

t, to ow-ot v to o v. i t y, b o

ot g vopg ot

wokg o g th ppy h thogh

o poto ot ppot by th

WHO. a to t tht o-jtb

v (.g. tbt h) g-

g ovt ft wy o -

g wth o , pt g.

aoth ttg vopt th g-

to o v to oth : v

(thpt hopy pvtv) o

o th py gowth ph toy;

bo, pp to wtht boog-

to ttk; po v.

nne Php h b vov oth wokg o gt b o th

g v po wow, o

ooptg wth WHO to tbh ft

v poto. O t -

g v xpt wth y y o ty

xp.

W hp yo tbh th vt po-

tt o ot-tv gob bk

v tg whth t o

ty, pg o xpo g

t-tk pojt tpot t,po vopt -p o po

tobhootg. W o vop o

v t b o v botyp.


41/154

Vaccines 39

nne PHarmaPlan serVices FeaTured in THis cHaPTer:

Mltot BSL2 ae alt

Establsh mltot oto

Staase ae altes a e oet

Theaet aes a the omse o the te

Egg-base ae altes

Halg GMO aoals

Bosaet & boset

Gettg state th maatg om ea to oeato

Lea ae oto

Teh tase a matte o o-ho

Meetg the ee o aes

eo tme

Bv no to to xtg

pht poto bg to

qf w ty o th poto o

t v gt pox. Th ty h to

b y vy t o to pov tht Bv

no o po th v o t rFP3

o vto o th poto o v

o gy th us.

A ll moese, alate alt

Th pojt ty p o thpvo pht poto po. a

xtg to w th po-

to w oh g

vto w po bo th ot-

to o w po poto .

nne Php hp th to wth

ph o th pojt o y ttgy

t to to opto opt

th pojt jt 11 oth o b g to

hov. nne Php w o pob

o pog bg vot pt poto pt o boog gt.

i o to hv th t-tk pojt

xto, hot o tg k: sg thoogy mvy p pojt xto itv tbg vovg ,

g otto

Ese aat

Th t o th pojt tt-o-th-t,

t-poo ty, whh o ot h

otto o pob t xp-

o. Wth poto pty o

40 o o p y, th o-

py h th ppy o t t t v t bty to t gowg

.

Bv no ow pott pp

o pox v to v govt,

ot otby th us. a th opy h

oth v th pp, py b

o th ptt mVa-Bn thoogy. Th

b o v pog wth

bo, thpt v

to . Wth th v,

Bv no o hp o oth wo ot pg hth .


42/154

40 Vaccines

ESTABLiSH MuLTiprOducTprOducTiOn

i o to owt t g gt xbty b oop tht po v ookgto tg w, o pgg xtgt, wth tpot t opto o qt.

ao, ott bg g-y hgh t, qg opx

yt h HVac k yt, yop wt to pov th g to th tpot t. a o, th t t o th potopo t kow wh tyg bg. a t, op xb tpot t whth thy w o toft.

at nne Php, w ook to th -

bty o tofttg xtg ty og to tpot, vt ow ott ttg h -to ow vtgt th pob-t o g xb qpt ttgh g- qpt.

Th ppoh pty pott whookg t pgg pot t, ht oth t, bt thopt b th wy thoghth pot y.

MuLTiprOducT BSL2vAccinE fAciLiTy

Wh v t ppoh wth tght o tbhg w tpot v ty opwth qy tght o bggth ft pot to kt, t w tht otty og o obt opt yot bg totyw pott pt o th oto.

W ot o ot- wok-hop ovg GmP, ott/boty

thoogy opt to t gtoo tppo poto. a w t 3d g y o th yot po o to oot ootpt tt.nne Php pobty o pojt ph th wy o o-pt, b t g thoghpot ppot, otto tto gt to oogpvo qfto. at qf-to, w po po qfto po vto v, wokg PQ/PV pojt g/tto to th ty opto o tb bth.

a Bsl2 ty (boty v 2), thpoto t b o toow, pt to pooo o ot oo xt v h oo.Th qpt opt ob t- t t/g g-thoogy, wth g- thoogy oboto, b ppto,owt pog ttpot tog.

sg gv th ty b ovtg:

Fxbty o g o potopto

mob t pt t

dowt tppo t m wh tto

to m b y

sv t pot bpo th ty t y gv t.aogy, th ty t hot o

qt g tht th oo-otto btw pot;kpg po pot vg o-wy ow; kpg thpoto oo ; fyg tht th o ottoo th og.

at opto, poto pogvy by wthot otto oy o, th to w b tot th poto .


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Vaccines 41

THErApEuTic vAccinES AndTHEir prOMiSE fOr THE fuTurE

Thpt v w pt fyo th p my 2010 wh docop. y obt ppov o tpott v Povg, whh

xt th v o wth vpott . W t xpt to othpt v o o th woto th v kt bt th v- kt o pvtv v,h th HPV v.

Fghtg pott to oth v ty th how byth b. Gob ttt how tht thk o gttg bo th g o 75 18.7 pt, th fv ot ootyp o wo g,bt, oot, toh pott (Gobo 2008 ttt).

Th pptv o vopg

v hg!

at nne Php, w hv wok wth b o op tht wth - thpt v, h Bv no-, ak Thpt Oo Thpt.O p kowg both th yot th optg oto o -v poto hp th tt-p op- o g- v bothxp h pov o th tpo o pvtv v.

STAndArdiSEd vAccinEfAciLiTiES A nEw cOncEpT

Fo to o to to ofg.nne Php vtg ppgo v ty opt, go v botyp.

mo v t gv yo th hto t-tk yo pojt ow yo -vtt. Hvg ot o th g woky p tht th oy jotk th f g tg to t ojt v o. Th o o-pt b yo to ott yo vt-t w t o -ho t poby t ow vtt ot ow yo to po o p-yt, h poto t ov o th th wo.

O o opt o v t b o ty botyp o ttht h v tok o togt to th photyp f-to pp o bt v.Fty botyp tgt boty v oto gt, bkgo pogo oo, po t opto htt oty, whh o gv yoth o xbty to xp. it o tkto ot th ht ot btwgg o boott ggo GmP, pog g o tp po-t, bg ot wth g.

ug tpy g, w oo b o , g: ggth ov yot o pt typ o

po o ty; g xb g- qpt xtvy; og thpo h pob. Th w hgh fto oo ow th o tt k WFiwh t gvg yo th y pty.W bt th o ow-otot, ow th g yotot by py g o bttg -v o to bg to - yo gt th ght ty t ob p.

W o bv tht th ppoh byo to pov g o obv.

rotavirus

Example

lagovirus

poliovirus

yellow fever

rubella

HIV-1

coronavirus

ebola virus

rabies

Hantavirus

Influenza A

measles

Lassa fever

Parvo virus H1

JC virus

adenovirus

hepatitis B

herpesvirus

ranavirus

baculovirusVaccinia

Infectious bursal disease virus

Genomesize (kb)

22-27

8

7-8

10

2

3,5-9

16-21

12.7

13-16

13.5-21

13.6

16-20

10-14

5

5-8

36-38

3.2

120-200

150-350

100130-280

7

Strand

ds

(+)ss

(+)ss

(+)ss

(+)ss

(+)ss

(+)ss

(-)ss

(-)ss

(-)ss

(-)ss

(-)ss

(-)ss

ss

ds

ds

ds

ds

ds

dsds

ds

Family

Reo

Calici

Picorna

Ravi

Toga

Retro

Corona

Filo

Rhabdo

Bunya

Orthomyxo

Paramyxo

Arena

Parvo

Papova

Adeno

Hepadna

Herpes

Irino

BaculoPox

Birna

H

H

I

I

C

DNA

Icosahedral/helical/complex

RNA

Naked/enveloped

N

E

E

N

E

N/EE

E


44/154

42 Vaccines

BiOSAfETy & BiOSEcuriTy

i th wo o v, ot t

q o g o ott p tvto o wt, h t o wt.

nne Php h xp wth fttgott t p to Bsl3+/Bsl3agv to xtg bg o oth ttp, w t th tt pf hg h pojt po.W hv wok o th pojt y o th wo o o wth oty-pf gto govgth typ o pojt.

i to, w o o o boty, tk-g to ot th v oty w g w g g.i eop, th g b o thut nto sty co roto1540, ttg tht t tht o b to vop wpo o t-to boog wpo tb gt qto o oppo.

Fo both boty boty, w o- o th th g yot o thty. W o o o tht otb th bg o ggoto, bt t to b tgt toth wok ot o pop vov.

Th oto o v ottpojt th k t o boty boty w oow th oy, th wy thogh to vyy ty .

a o o, w o o oty oboth boott boty -pty o h oth q.

HAndLinG GMO ApprOvALS

Wh ookg to th wo o w v-, yo tht g b b o gty of og(GmO) o o ot, o xp th

o t o th v. Th

EGG-BASEd vAccinE fAciLiTiES

Wh th zg tt, t y toot to gt th o hot b- vy y, th o v vt wth tht y t, po o jt t o .

Th joty o hot t po gg-b t, whh tt btot w thoogy. Fw o th v po t, v w oth typ o tv gt, h v-k pt o oth w ggthq.

ug gg wok w o o v.Bt o th p tto, wh ot ov vy hot t ,

th o o ppoh gybtt t to v th y o th t vb.

dgg gg-b t q k gg hg th pf pogq, h hg btgo o gg o v poto.a th p pt o th v-twt q p hg oto po y-to-h wtt.

W hv xtv xpt th ,g o o g- pojt w oth gg-b th-oog k ceF (hk byo fbobt), .g. Bv no t-tk -tg ty.

tht t both h bo-to - tg t t vy pf GmO qt.

Wth xtv xp GmO q-t ppov, w b to vt

GmO qt og y othott-t qt.

W o hv xtv xp o p-pov o GmO pojt poto whh, w ty ppov, oq o wokg wth GmO gt. W hp yo pp pf xtvk t, w yo poo th hg o gt, p, t xt tpot, wt oth po-to t.


45/154

Vaccines 43

GETTinG STArTEd wiTHMAnufAcTurinG frOM idEATO OpErATiOn

a tt-p opy tg vy ot tgg to f pop wth hgh g o p kowg. ith , nne Php hp. O-ho xpt yo w wyhv to th ppot yo whttg p yo ty.

TEcH TrAnSfEr A MATTEr Of knOw-HOw

mot op kow how h t bto f th ght thoogy o pfpot, o t o to t th-oogy o t to t o o pttto ptt, o xp wh tkg pot o - botoy wokto pot- vopt poto.

nne Php hp. O t h tog bkgo th v t t ogto. ao o po ott b to po ft thoogy cmO h (cott mtgOgto). W o hp yopo thoogy t.

W k tpy t v-b to yo tht p vpo ott-t ,g th hg o th htot btw Goo mtgPt (GmP) ott.

LEAn vAccinE prOducTiOn

i g, b ggt tht o-

p potvty by o20-30 pt by ptg l ph-ooph, thq too l v hp boot poy tto.

Th l too box g, bt t nnePhp, w ob l wth -pth kowg o hg, po ow,wt ow, GmP/GmO/Bsl qt th oth pf tht tth t o v poto. Th w wok wth yo o th y g

ph to tbh th bt wy o yo tobft o th l too thq.

a o o o l pojt, whl to opt xtg po-, w hp yo by tkg th o ohg gt. Wh wokg hggt, w ppot yo by:

spyg optg wokow V t ppg Otog ppot to iptg tot qpt copo tvt ctg tg wokg po

O pbt ov th tt-p kow-g yo , o ppg btyt b tg t, to gg ty opt ppg t o tt-p.

a b th t tt-p o qpt k, w o to hp wth og-to vopt tg, wtg ot optg po (sOP), q-fto vto, thoogy t v poto.


46/154

USA. Cardiovascular diseases cause 40%

of all deaths in the United States. This is more

than all forms of cancer combined.


47/154

phArmAceuticAls 45

paaa

Tdas pamaceutica mauactui is

me cmpicated ta ee. We e a

uiue mi ca ad a epeiece

t ep u ecme cuet ad utue

caees.

t o oy o a o a-

aa a 1899, w Bay wa

awa a o A. s , a

a oo a o qa-

y o o ay o by o a

o oa a o a w a oa.

i a, aoa aaa oy

a ab o a y o a o-

way o ak , w w

y o a a o o yay .

toay, ay aaa oa a

a a xy o a o a

oo bo o a

o. t ao aaa

bo by oo a oa a o o o ao

wo. t o o- o-

o o a a w a o o

a o o o qay. t

aaa y o o

o w qay aa, o

oo a o o-

y a.

t a o aa aoa aa-

a bo o -a,

o a y o y a o

o aaa oa. nw

o aw aa, oa o o o-

a aa, a ay ao-

a y a, o ak, y ba

z, ao, ab o aab-y q a j o xa.

t xy o a a aa y

a o bokb

a. ioao- aaa o-

a a ook o ay a

aaa b ba .

W kow a ay o o o

a a w o o ay

aa. A a oba oay, w oow

a oo o ao, b-a y aa a ooy

o o oba wok. A o -

oay, w o oay o o

ay o, aa o yo oa a

w a yo oba a.


48/154

46 Active phArmAceuticAl ingredients

A aaa

Cuet teds i actie pamaceutica

iediets (API) sw iceasi s-

i actiities ad simutaeus adaces i

pduct ad tec. We ca ep u

dea wit t.

t y o a ba a-

o o bk o a aaa

. t ajo bokb

a o by w-ab o, a

ay o a o o a -

x o w x x w ya.t a o a , a -

a a o o a a

o o o- aa.

i a o, a o a

b o Api a. B

o o, aay Aa,

ow a b a o a

o oo, a o a o-

o o aaa. B a

aay , boo Aa

aa y a a

ooy a, a o a

gmp oa.

Fo a o , ajo o

o a. t aay ow a oqy

ao eo a us a

y . B w, yay o a,

aaa o a o.

t w a a oo,

a a o ox

oa q, o oaoaaa, o o o a

a a a w aao o o-

ao o aoa .

A nne paaa, w a o x

w a b o a o, -

y a xao o. W ao

o a kow o oa o-

o a k o ooy a a

ay o o- oba Api bk

aa.


49/154

Active phArmAceuticAl ingredients 47

Fm dieta suppemet t

pescipti medicie

caoaa a a 17.1 o a

ya wow o a ay o a.

may o o b a w a

a , ao o -a a

a o oa-3 ay a.

t nowa oay pooa Bopaa

oy o o a a-oa

oa-3 o o a oba eu a

FdA aoa o o , w

a a o y aa oay o o o-yoaa

ao. t o ba a Oao

eo a Aa, a loaza us.

t aao o Oao/loaza a -

o pooa Bopaa w a

b o a. F o a, goo ma-

a pa (gmp) a o

. soy, a ak -

a a o a , qk a o-

o aay. nne paaa a x

o oay bo a.

t ooao a 2006 w nne

paaa a pooa Bopaa w

a xao a a o pooa x

a sajo, noway. W a

oo o pooa Bopaa a o a

xao o oo aay o

w z, nne paaa wa aa

o o , a a da ao wa oo oay oo a o

noway.

t oo o oo

ay Kabo ow jo a-

o a o- -o ao-

. nne paaa wa a o oj

xo o o o co-

a d, da d, coo,

coo & Qaao, po vaa-

o a Aoao ao.

nne paaa a a ky aaa

-o, w

a fxb oj oaao a a o-

ak. t nne paaa oj aa

a a o w pooa oj a,

a a o o a o y

a o a oo. t o

ky ak o oj aa wa o ak

a oy o

nne paaa o dak, gay,

ca, ia, sw a us w o-

ay k o a o o a ow o.

t w a-o--a a ob pooa

x oo w a oa oo

aay o 1,200 o ya. t oj

wa o w b a oy 20

o wk aa o !

nne phArmAplAn services FeAtured in this chApter:

Tec tase: cmii state--te-at wit ca pactice

Secui pduct uait we si

Upadi Idia API aciities

Eciet i-ctaimet API aciities

Dectamiati d aciities

Maste Iie w t impe mii iuids

Ctaimet i a feie pit eimet

A eee utue: te eaissace stesis pducti

Autmate t ptimise: te wa t me cst-eectie CIP


50/154


SECUrIng ProDUCT qUAlITyWhEn oFFShorIng

d a ya, a ao- a aaa oa aa o o - qay o aw aa a oaa o w ow qayaa (gmp aa). A a, oa a bo o awao oa oo b o o- o o oo oo o o.

A nne paaa, w a oa a ab o o yo oayw a a, ok -o a a aay o b- ay o, ia a ca.

W wok o w yo a qaya o o a a qayoao o o a b- o oo a a yoxao.

O o a o by oa -oy wo ak aa a ooo kow o oa a Wqay aa. t a o a a qay aa a a oaboa w oa oa o a o ob ab a a. uay ao aa o o o wo a o o oab-.

A , nne paaa a o ca (taj, gazo asaa) a ia (nw d,moba a Baao). tyay, w wo a a o aobao o oa a aoao, a w a ooy woko x o a y aay b o o a o o o

ao wo.

aa a. O xow a ob W a oakow-ow ky o ,o w a o a o o o a o aa.

t a a ayoa o oa w w-kowo a a o o a abo o o a. i a, ayay ya o kow-ow o o-, o a q, a w o b o o oaa a.

mo o a o kow-ow o, w ak b-, aay a o oo kow ( oo o a a) .

eab oo aay aooy a w ao oay. i q - o, o,ooy a q aa w a oa b a a

a a aoy .

nne paaa a oaa a oo ooy awa a a a eo o coo. t aa o -a o w oa aoyq ab a ooy aa o aooa oa ooa o aoa qa-y aa.

TECh TrAnSFEr: CoMbInIngSTATE-oF-ThE-ArT WITh loCAlPrACTICE

i oay oba b o, aa a z aaa oa- a a aoy a a ay o o a y o ay aa- o o a iao ca. t a a a ao ao o aoy ao o ay a o qay ob a -aa oo o o. A xa a 2007-2008. t ao a o o ao o oa aao a w a w oo.

t a oa a ao o a y x w ao, o-o o a ooy -a ao. Aoy, a okow, o a qay aa a a o ay W oa

a wa o wok w c o iab-.

W 10 ya o a x ak, nne paaa a a boawok o oa w a a-o a oa aaa oa ay o, ca aia. W a wok w ay o oo o a y o kow-ow(ao kow a a) oow bo oo oj a oa


51/154


EFFICIEnT hIgh-ConTAInMEnTAPI FACIlITIES

W a w oo o -o a aaa ,ay a aoy oa a ky

ao. t a o o o-o a a o a a a o o o boaa.

W b, a qay oao , nne paaa x gmpoa a -o ooyak ob o a o Apia, a a a oa a ao w bo eoa a us-FdAgmp q.

a. A a aa a o b a o o a. do b, ia Api oaq a aoo a b w x ay a a a a xo.t a a , a aoo -q a hvAc oo a a ao a w b.

t ab o a aoo oa by a a ay Apia ia a o o aa , wa y ay, a a by a ay o.t a a a y -o qo ay o bok ay, w o o a bok, aow o .

UPgrADIng InDIAnAPI FACIlITIES

ia Api oa a ow a ow- a oo of o qay aa a w aa o bo oa aoba ak. A ia Api ak aa by oo, aa a o a aoj a o o oa-.

so a a o o o-o a a b a w ay, ia oa ay oo o ooa oo o a- x a. B aoo oo ay o a oa a oo o W ooyaa a aoa ao o .

A nne paaa, w a a o ab o ay a a oj o o ia. i a o oj, a b a baa o o, a o ia ak o aby o o a a ow . i ao,o ia o wa o aaay a fxby o o ab o a w o aa-.

t a a a iaApi a o aoa aoyaa a a y w oay wo ay aoo o o-

A ab o aoo ax ay q a o b o, a oo ow a-b. W a baway b o ia oj, oo o a ky a o a oa.

i o a, o o a w: o o oo,xo o aay a FdA oa.t oo q aa bokw a aa wa o b aba o a . to aa a ooao, nne paaaaa o oo -ow o oy 2-3 ay.

mo a o a a w oa q. i a b aa a x ay, b oooy a k aa x- o ak ob o o -ow oa a.

i a oj, w w ab o a o a -oaa w a o o o y o w ay boo.


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MASTEr InlInE hoW ToIMProvE MIxIng oF lIqUIDS

t x o q aoay aby ba o x y. Boy a aaa a:

sow iaay

loa o w x h

A nne paaa, w a oay oaao oj a w - oaao a a aa obo a o y o a o.O oaao oa oa oow ba : , a ka o y oa oaa-o k, o a oq. O ba o k a, w oa oaao a a bqy,

DEConTAMInATIonoF olD FACIlITIES

r a x aaa ayo a w o ay a a - aa o ab a w ay w o y o wa b o a b oyo ay. Aa o ay , ay a oaoo a b , a o oay. e aw aa a a a, o x a a a a aao o ab a aao.how, bo ay w o a bo o a x aaay, ay o oaa ay q a y o o-oaao bw x o- a w o. d o o qo, q ooaa a o ay a b y, ay a o abo aoo.

Fo a oo y,oaao o a a q o o a aa--a (cip) o. A ,oaao o baa oow cip a a o o ooo a-.

sa oo sy o aao no-ooo x iaby

nne paaa a x a wx y a w a ma i. ty a oa o o y. ma i x q

a x oo w a fow a

InlineBatchMasterInline

x5

w w o a/oaa-o a. t oow by aa aao, a ay a aao o a a o o a -ab .

W yo wok w nne paaa, yow a oaao oo a o o yo ao.

a o, o oaaa.

F o a, w o o o- aby .. xy aa oo oh (h o 0.01) a/o oao o ba, o o w ooa o w oao o ha o o aby a h aa-

o owa a b qa a.Ao aaa a o o a a by wa o oa a o- y o a, oo . i a-o, ma i w aq o o o a aq, a x a oaak, oo b aao w a o a x a a o ob q o a a ay a b aa o.


53/154


ConTAInMEnT In A FlExIblEPIloT EnvIronMEnT

h oa a oo fxbya o o o b wo, ayx aa obj a oo o. B oa- a a a aa o aoo y a o o a a a o a q a- kow-ow. t aay w o o o a.

By a, a o a b fxbo o aooa -ooo o a ay o x oa , o kow, o.O o a, aa o oa o qx o o o oa- a a, , oaao o a o. i ao, w aay a a w a o o, ao o b xoo-oo.

Ba o nne paaa o x oa , o o oo awa a ky oa o a o o a.

t a a nne paaa a o oj o a ky ba wa y b-a o o, a y oy o a w o . W w o-b o a oj a a ook a o aa. A a , ky oo a y ooab oo o o.

AUToMATE To oPTIMISE ThE WAy To MorECoST-EFFECTIvE CIP

coa a y o aay oaa--a (cip) ay aoo ay a-o oo a a o ay a o aa 100 oy o o a qo x. so aa cip a a a o o o-o , a oo a o b o a o, w aak wk.

ua o y-aoa cip oo b oo o ak a o aa oa x cip o. A nne paa-a, w a x o a w a

o cip-a oj aa abo .

ry, o o o o o o oo o a aa oo aay a aa o a. t ay wa o aa aa o a boaa o o. cabw oo ba a o aa wa o aa ox.

t cip q a o b fxb o oo a a a o-, a o b ab o aa o o q, o xaak a/o , a o ao oy a a a. t aa- o wa oa by a a oo o a a k o xoo. t a oo o b o.

nne paaa a cip qo b y aoa. W ao a o o oa ao a oo a w o a wao o-.

t wa a a cip o wk o wo ay, a bo q o a a a oo o 80 .

A grEEnEr FUTUrE:ThE rEnAISSAnCE oFSynThESIS ProDUCTIon

A o a aaby abo o aa oba ooawo, w aa a boaa, y oo aoba a owa a ao.A a , y a a akao o y oo obooo ya a w aa a a b az o aaa y awow.

nne paaa o a a a oa o kow a xw y oo a w a aoo, o y o o,a wa oa a y-aa, a a y o-a b a aab oo.

i oo w ab o xaa y oo, w a b a aaboaboao a wo a yo ow o x a b wa a o o ay o a b ob oo.

nne paaa a a a a, ay

a o (hse) o, w o oaboao w yo a yo q- a o a aaboo a o o-, y-a a o-y y oo.


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52 Oral SOlid dOSage

O so os

Increasing demand and competition or

Oral Solid Dosage (OSD) prodcts orce

manactrers to optimise prodctiit and

cost-eectieness. NNE Pharmaplan oers

to acilitate.

OSd poucts th omnnt phmcutc

pouct om ssn n o s-

ss n w known s w s comotb

om o mcton.

Th busnss mwok o th phmcutcnusty hs chn n cnt ys wth mjo

nunc on th mnuctun n mktn

o so os poucts. exp ptnts o

bockbust poucts cs th mkt o

popty poucts n ncs th mkt o

ncs. Th ck o nw chmc ntts s

to ck o oow-up poucts. Cost ncss

n th hth c sctos o th wstn wo

combn wth th sp o us to mo n

mo pop n ss op counts mk

pcs s.

Ths stuton hs n s to mjo chns n

th poucton mthoooy s w s sup-

py chn o so os poucts. as hs

ncs ts poucton cpcty mtcy

scn both oc xpnn mkts n th

st o th wo. Fc comptton btwn

mnuctus hs so sut n xb mut-

pupos cts n mo mn o ow

unt cost o th poucts.

in th nc u scto, mnuctus n-

cs poucton cpcty tkn o popty

poucts. Th tton B Phm compns

n th xpnc n know-howto mkt quty bn ncs.

Spcs nw us such s sustn s

omutons n combn aPi poucts s

w s optms tons o xstn us

ntouc to th mkt to ntt th

supps o so os oms. Hh potncy

poucts n nw oncooc poucts, qu-

n hh opto potcton, nt th mkt.

NNe Phmpns s py no n th

opmnt o both so os tchnoosn th ncs poucton cpcty n euop,

th US n not st as.


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Oral SOlid dOSage 53

Ho to pgrade GMP

and maintain ll prodction

How cn w nsu poucton uns smoothy

wh ou poucton cty s mp? Ths

s th chn Mz goup Scs n g-

mny psnt to NNe Phmpns nn-

n n constucton mnmnt.

Mz goup Scs h poucton cty

o oms o non-st os, ncun w

n o o poucts tht t n to mk

uy gMP compnt n t ws mpt

tht th pojct not supt poucton.Mz goup Scs sk NNe Phmpn

o suppot n pnnn n xcutn th

pojct n to hp mntn poucton

cpcty thouhout th up so mkt

mn cou b mt.

at NNe Phmpn, w b th bss o

smooth pojct xcuton s cos coopton.

an, wth th cty n opton thouhout

th pojct, y tm h to ct qucky ncsy. W coont th poucton,

constucton n nstton tms to mk

su ths hppn.

in cs o sun s n mn, th cty

wou h to b b to mt t wthout

suptn th up pojct. NNe Phmpn

pouc s scnos, ch wth ts own

sk ssssmnt. Ths nb Mz goup

Scs to mk th bst cson, wthout

osn sht o th os.

Th NNe Phmpn pojct mn xpns:

Cos coonton n oo communcton

wth th custom th ky succss ctos n

th pojct. Thnks to th ptnshp w h

op, i most k pt o th Mz

goup Scs tm.

NNe PHarMaPlaN ServiCeS FeaTUred iN THiS CHaPTer:

Cost-ecient OSD acilities

Prodct optimisation and deelopment

Mltiprpose high containment acilities

Lo cost prodction technolog transer

Optimising pacaging and logistics

Radiopharmaceticals

Optimising material and personnel fo

Process Analtical Technolog (PAT)

Ne trends in manactring o OSD


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sy to xtn ncssy. Th bunscnt tchnc s cn b ccss wth-out cossn poucton s, so mnt-

nnc cn b c out wthout suptnpoucton.

To s th nw yout, NNe Phm-pn us 3 o 4-sht mo to ch stpws ncs n poucton cpcty,pc o poucton qupmnt n nstton qupmnt n th s swthout ntuptn poucton.

Fom sttn cpcty o 2.5 bon tbts y, th poucton cmb to mss12 bon y.

PRODuCT OPTIMISATIONAND DEvELOPMENT

Fomuton n so os oms un constnt opmnt ssnssus k toxcty, conto s ncountt.

COST-EICIENT OSD ACILITIES

a o ou O So dos (OSd) customs

sk o nw pojcts sn o th bstbnc btwn nstmnt n unnncosts. in ton, thy qu th btyto ncs cpcty n xbty wthoutsuptn th onon poucton.

in o to uf thos mns w ppymny nt mthooos such s iT smuton o poucton euton o nt tchnc soutons

un sn phs leaN sn estmton n optmston o

poucton cost rmp up consutncs

Fo custom n gmny, w stt ounnn xcuton by mkn poc-ss smutons o nt pouctonscnos, tkn nto ccount tonsn yout, sht mos, poucton tm,mntnnc tm n btch szs. intnsto n tns cpcts w sotkn nto ccount.

Th sut ws n OSd poucton bunwth tc mt ow tht wou b

counttn by n ch btch unqufnpnt. Ths fnpnt s not just onpckn mt, but on o n chnu tbt. Tkn such msus cnhp uc th conomc sk.

Whn th mnuctu n th n-n stt opn nw pouct ombotoy to poucton, thy h thoppotunty to combn NNe Phmpnsknow o th tst ncs n qup-mnt tchnooy wth th own schn ct hhy comptt cty omon os oms.

NNe Phmpn os n o soutonso tton pojct xcuton, ncunstnston, optmston ln po-mnc n Sx Sm stus. W so osoutons tht o bo n byon thmttons o stn nnn, hpnou customs o mo thn my owth b n fx costs. Ths s whNNe Phmpns unqu nshts nto thphm nusty tu u to younw poucton cts.

NNe Phmpn s b to suppot mnu-ctus n to ths opmnt. Wo hp to fn nw omutons nos oms, o xmp psonstbts to ncs tcbty n spys ostps wth ct pnt aPis. in ton,nnotchnooy w to mo scupoucton pocsss, hpn to pnt


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MuLTIPuRPOSE HIGHCONTAINMENT ACILITIES

dun th st 10 ys, th phm nustyhs sn snfcnt s n th numb ohh-potnt ct phmcutc n-nts (aPis) s w s oncooc poucts.Th tm hh potnt chctss sub-stnc tht poucs mk phmco-oc, physooc n/o toxcoocct n th cpnt n n sm mounts.

app t th coct os, such sub-stncs bnfc to th hth o ptnt. But s un th mnuc-tun pocss, thy my h s ctson th hth o th optos. Ths mnstht qumnts o goo Mnuctu-n Pctc (gMP) s w s Hth, Styn enonmnt (HSe) must b tkn ntoccount. an bcus ths ut bytwo nt st bos, th qu-mnts o not wys conc, so soutonsh to b sn to stsy th ns oboth gMP n HSe.

Bcus th nw aPis n oncooc po-ucts tn to b mo hzous thn thpcusos, th qumnts o potctono optos n th nonmnt h so

LOw COST PRODuCTION TECHNOLOGy TRANSER

Mny phm compns c th ch-n o tnsn poucton qupmnt,poucts o know om on cty tonoth xstn o nw cty. You mywsh to sc up om pot cty to -sc poucton. You cou so h ob,ophcy ntt pouctoncts o wnt to mo poucton costo you customs to uc tnspottoncosts. Oth puposs cou b to cttyou contct to oc uthots n buys

o to mnms bou n w mt costs.

Th tchnc tns pocss nos -mnts such s gMP compnc, utoymns n tchnc know-how. But soth humn soucs tht not b nth xstn poucton onston.

Thnks to ou tuy ob psnc, NNePhmpn cn suppot such tnss by:

ncs. du to th mt knowo nw substncs chctstcs n thopmnt phs mny o thm w bcssf s potnty hzous o stysons. Hh contnmnt stts wtho b ntu pt o th phm-cutc opmnt wok n poucton.an thts not . appyn th tst skssssmnt mthos to xstn aPis counow cssy mny o thm s potntyhzous.

Substncs w b cssf bs on thmss t tks to cus hzous ophmcooc/toxcooc ctty n thcpnt. Such cssfctons xpsss th Oel (Occupton exposu l) oth OeB (Occupton exposu Bn). Thw-known BUCK pym s us to xpss

th OeB coss f bns, om OeB 1 toOeB 5 wh th OeB 5 s th most hz-ous on.

Th tns tows hh contnmntmutpupos poucton y chn thcontnmnt stty ns cty. Hnfn known hzous nomtonb n th phmcutc pocsssn, t s mpotnt to bnc optonnss nst opto sty, coss-contmnton, compxty n optoncosts. Ths wy w ct th ncssy nsufcnty contn qupmnt souton.

Th o s wys to o pson potc-ton un th pocss optons n tontt contnmnt n CiP n th pocssqupmnt s s possb.

Pojct mnmnt n souc oc-ton, both ntn n xtn

Mppn oc supps o w mtsk f, bns, ubcnts n aPis wthth ht physc popts

Mppn th xstn poucton stupsuch s nuton pncps ntbt tchnoos

Mppn th oc supps componntn pouct ow to nsu optmumy o xcpnts n oth wmts n tms o ostcs

Mnn th momnt o qupmntwhn n

int-cbtn tst qupmnt estbshn tnn n tnstons o

stn optn pocus Stt-up o poucton n qufcton

o th tns pocss

Whn xpnn you xstn busnsss ontn nw mkts, w cn so hp youons th know-how pos o younw poucton cty bo, bs on ouob ntwok.


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OPTIMISING PACkAGINGAND LOGISTICS

W h pon tck co o hpn cus-toms op concpts o th pcknmts n sn, pckn pocss nny t ntn n xtn ostcs. Ountt ppoch s to optm tnspotn sto unts, fcnt us o spc oostcs n ct whous hnn.

W nys th conomc spcts o no soutons to ch bnc btwnopton fcncy n nt outy. Ounns ccut ows n spc o ptsn coss-cot ythn om chtc-tu n bun scs to gMP compnc.Ths unts you unnn pckn nstht cost-fcnt n s.

OPTIMISING MATERIALAND PERSONNEL LOw

Som O So dos (OSd) ctsh own o mny ys sutn nnfcnt n somtms non-tnspntpctcs. an OSd sts my not hfx ows bcus ch buk pouct hsto b tns om on stp n pouc-ton to th nxt. dnt mthos nhnn concpts cn b us n p.at ch poucton stp, buk mt hsto b sto n ntm sto s. any hou, somon hs to chck th sttus.

dun ctys cyc th hs to bn pton o cpcty, tchnooy nonston. Ths sy ns up n wcombnton o css-coss ows t ss o compomss n sn, youtn pocu. in ty, th s otn ot o oom o mpomnt.

a typc NNe Phmpn gMP-uppojct wont just tck th HvaC nmp th xstn pmss; t w soncu chns to mt n psonnow. Fo xmp, stbshn cownn n ock pocy mnts coss-contmnton, ss th compnc nucs th n to us pcous stospc n th poucton . a poposchns h to b compnt wth u-tons n tchnoos.

RADIOPHARMACEuTICALS

On o th most mpotnt constons sth potcton o optos n thnonmnt nst oct contmn-ton. du to th octty o thonucs, optos h no ct

Fo nstnc, NNe Phmpn cs out ostc nyss o customs xstnwhous. Th o s to optms ntnostcs n pp s yout wth shot ow n ss tm. as sut,th custom w s spc n mony.Th spc tht s up w b us toct nw pocss wthout th nto bu costy xtnson.

Bss tton nnn mthos,w cn so hp you combt counttnwth mon pncps n tchnoossuch s ss unqu 2d con. Thsnbs smss tcbty om pmypckn to co pt, so tht chpouct cn b qucky ntf n ft y st o th pckn n ostcschn.

contct wth, o ccss to th pouctonnonmnt. a hnn pocus c out usn mnputos o utomtsystms n hot cs. Th opto s potc-t om oct contmnton by shn, ncun ss wnows. atNNe Phmpn, w tk ptcu cto mk su o th poucton nstchnc componnts n soutons b.

its n ssnt qumnt to mk sumntnnc cn b c out sy nsy. On wy to ch ths s to pcctc nsttons wh th s nooctty. anoth wy s to snsmp, obust componnts o th o-ct tmosph tht sy to mntnn pc usn mnputos. Th sko oct k om th hot cs smnt wth nt pssu n oub-unncy hnn systm.

Poucts n th ophmcutc nchncu cpsus to tt thyo sss,tumou-skn st njctbs n tnymc cs whch cn b njct ctynto mnnt tumous.

Snc 2002, w h bn no n spojcts tht us octty to tct ntt spcfc mc contons wth phn mm tn sotops. dsnn

poucton ns o th poucton o -ophmcutcs qus spc know-how.Most poucton ns sn omsctch bs on th ptcu qumntso th onucs thy w hn.

NNe Phmpns xpnc n know-howcn b us to pouc ophmcutcssuch s: St oct us roct mc cs roct us o o os


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NEw TRENDS INMANuACTuRING O OSD

To mt th ncsn comptton on thmkt n th tns tows mo potntus n mut-pupos nc poucton,t s mpotnt to ocus on:

Pocss qupmnt sutb o ntpoucton mthooos n btchszs

Pocss qupmnt wth shot chn-o tm btwn nt poucts sw s ct n sufcnt cnnpocsss ntt n th qupmnt

Contn pocss qupmnt o p-son potcton, on coss-contm-nton

Opton xcnc ncun lnn ct suppy chn mnmnt

Sustn s omuton to n-tt nst th compttos

ln xtnson poucts to ncs th cyc o th aPi

Combnton poucts o btt th-putc cts

Smt n s pckn cs tonsu th bst hnn n us o thOSd pouct

instmnts n ths s toth wthbnchmkn w to mo cost-fcntpoucton n ow unt costs.

Mny OSd mnuctus s th -fcuty o mpon th busnss ptomon th own n tho us consutnts.Contctn wth us to nstt n fnth oppotunts o ncsn you op-ton xcncs w nsp you ons-ton to mo ow n th ht cton.

PROCESS ANALyTICALTECHNOLOGy (PAT)

Pocss anytc Tchnooy s powutoo o opn O So dos (OSd)poucts. Commony pp un pouctomuton n th opmnt o thmnuctun pocss, t s so usu ncommc mnuctun o montono conton pocss n pouct-ctcquty ttbuts such s ntty, pp-nc, ssy, contnt unomty (CU), putyn ssouton.

in opmnt, PaT toos us to nknow o pocss qucky n systm-tcy. Ths toos ncu: dsn o expmnt (doe) pnnn

too tht poposs s w xpmnts spossb to sn th pocss, ntyctc pocss pmts n th nsthy cn opt wthn to thht pouct

Pocss nyss, ncun both smp,un pocss snsos such s tmp-tu n mostu, n mo ncpocss nyss such s n n(Nir), n, rmn n ocus bmctnc msumnts

Mutt t nyss us to nyst om th ous pobs, sutnn pocss tck, msumnts o n-pocss mt chctstcs o ms-umnts o pouct quty ttbuts

actn s consutn ptn to th phmnusty, NNe Phmpn hs wth opctc xpnc n PaT om dsn oexpmnts, mutt t nyss nth ntfcton n mpmntton oonn pocss nyss. dsnn obust

OSd pocss upont w nsu you sttun on nstmnt (rOi) on you nst-tons. at NNe Phmpn, w ct s youpctc ptn who ntfs th ppochtht w to cost uctons om bo-toy to ptnt. Fo nstnc, w consut ob ky ccount wth to sconypocss utomton. Tht s th ky ssuo mnmsn costy n unpctb r&dunctons.

in most css, ct PaT ppctons mpmnt n mnuctun, contonpocss pmts o mt ttbuts.ino n s PaT ppctons, w hxpnc o usn Nir to nty w m-ts n th spnsn , to conto thbnn o nuton n-pont, to ms-u ssy, CU n ssouton t comps-son o to conto th mostu n u-b nuton pocss thouh utomtjustmnt o th nt tmptu.


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58 Medical devices and drug delivery systeMsDR CONGO. Millions of people are injuredand infected through unsafe injections every year.WHO, UNICEF and UNFPA have a joint policy to useauto-disabled syringes when administering vaccines.


61/154

Medical devices 59

M

Medca deces ae a wde range o

appcatons, bt t reres epert

nowedge to deeop and mproe tem.

NNE Parmapan can assst o wt a

sses eer step o te wa.

M p o m -

. t p-

m o, o

w o m om po

o pmp.

ao m mm ,

q om ommo o x-

p. Fo xmp, k m

w mpo o po

qpm; wo poo o-

boo k opm

po; wokfow m poo

o w o ;

m poo o b

o o- gMP omp.

M o - po

, iv b w -

o o . O xmp

m , , jo m

, o-m qpm

o moo m, w

-wo po mp

o oom .

gow opm

o po w o-

o mpom b o w ,oo m.

a nne Pmp, w o p-

po p o m -

, om opm p w o

bm mpom o po-

o . a w kow ow o opo

o po opm o

o, o- .


62/154

60 Medical devices and drug delivery systeMs

M m

Brngng medca deces rom concept

to maret wt ast, reabe and nnoate

sotons s one o NNE Parmapans

speca competences and eds o

eperence.

W o ob p oo

pm bo , nne Pm-

p w k o omp

m pomm, om

po opo o m-

po w o mk .

nne Pmp b -o -

o p o noo nok

m . O

, w o o w

mk b w om

o pmo w

o o wo- jo

. to w ppo noo nok o

o.

nne Pmp mo 75

w m poo kow-ow.

W o w o omp po

w p om o oo.

O kow b o o xp

w m , omp .

W o o o wok o

o w o om r&d oo

w po w o o

m m.


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Medical devices and drug delivery systeMs 61

nne PharMaPlan services Featured in this chaPter:

Prodct nctonat testng n R&D

Estabsng sem-atomated and g-speed prodcton nes

Reampng estng prodcton nes

Medca dece adaton

Te trobesootng process and ts mpact

Speccaton and estabsment o pot epment

Goba transer o tecnoog and epment

Rs assessment o prodcts and prodcton

Assessng medca dece CMO enronment

Epment spper recommendaton

Desgn patorms and febe prodcton aots

Streamnng goba prodcton set-p

Data-dren prodct deeopment

Srnge desgn tat maes a derence

u jo p pobm

op o. s o

mp m, ob o p o -

aids hp B,

mo o mo .

uo, ob oo

b .

t Wo h Ozo (WhO) kw

o-b wo ow

p o boo bo o

op o. so o p p oo, WhO o nne Pmp o

xp poo ppo. O -

op o o-b

w o-w mk

mpob o mm

q b o .

O o ow b

uniceF.

to po , nne Pmp

m p w o om MedecO om

u ab em. B poj

q mo j poo

mpmo; p om o

nne Pmp kow q

k poj o b w

ab db. Poo 2003

MedecO b

pm o o-b o

uniceF.

a xmp o

m ,

o-b po .

uniceF o o p o, po-

o w xp 2006 2007

o o poo .


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ESTABliShiNG SEMi-AuTOMATEDAND hiGh-SPEED PRODuCTiONliNES

yo m / ombopo w o o q-m. yo o o b b poo o w -o wo m o wokfow

o o mb o ok opo m . O ppo o oo p o bw mb o ob qq .

W o , nne Pmp xp o b m-omo -p poo o, bo ob ox o m-ppo .

O xp o p o po-o p, po-o b o, p qm,o ompo fow, qpmpo o o qpp. W o wok o w pp- w o qpm o poo mb .

W omb o pm pokow w o xp xpoj. W w om o o q-m po o pooqpm po o bo-o. a nne Pmp, w o ko o qpm pom o qpm mb o q. u o, w po Fo s ap t(Fat & sat) io, Opo

Pom Qo (iQ, OQ & PQ).

yo o mpo w o b-om m w o w qpm, ow poo mpo o ppoo w p o pom pop m- o o poo qpm.

no o ppo opoo ; o o -o-- oo b o op mp-p o poo.

REvAMPiNG ExiSTiNGPRODuCTiON liNES

a q o omp oo w m o opooo, o m o mp omo o x poo m qpm. t po,ow, o mo omp om xp mp o ox poo p o o-o p.

t m o o. doo w po o ooo po? do o o-m po po o x qpm? a p?

io w po ompo w p m o -omjo-mo o wjo mo m w -p w pp. yo w o oo w o m oo w, p omo it p. a w p qo b o m po om o w mo jo mo o p p, o-o o p, bmb, pk o w po, - po erP m w o b o o P 11.

a nne Pmp, w ook opoo fow o w qm o p po oo mpm o o - o o gMP. W po o o-p omp o opm fow o mp.

PRODuCT uNCTiONAliTyTESTiNG iN R&D

a nne Pmp, w po p o m poj. W om o o o po poop,om o k o p m p r&d o opmp o poo-kom .

W po -p, qpm o wok-k m-k mo.W b po po o

po opbw o qm pm. B m p w mm m opoop, w b o opm o m. t o bw po pm b o o o o.

O o o p o m p pb o r&do. a w o b po - o ppo b o d osx sm (dFss) d o expm(doe).

Feasibilityand

proposal

Deviceplanning

Launch(scale-up)

Designand conceptverification

Developmentengineeringprototypes

Detaileddesign

verification

Productvalidationand pilot

production

Businessopportunity

21 3 4 5 6


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Bring focus on production backto early stages of product development

Production

considerations

(EUR,allocated)

Project execution [time]

Impact onproductioninvestment

Focus onproduction

MEDiCAl DEviCE vAliDATiON

v m o

o- gMP omp p o opm. tpo b w k o po poo qpm, om b o o mp o o poo qpm.

nne Pmp o o bopm o 820 gMP: Po -

ThE TROuBlEShOOTiNGPROCESS AND iTS iMPACT

W op w o o po-o- , o o o omo om q j bo o nne P-mp o p.

F, w w o bmb m- po pb o p q oo .W po p om pp.

t om o opm-o m mpom,b p q w o q o po. t mo oo o p w pb, o w

w p b o o m- po kow. t oow ompo m w o b o poqm m o b pomm w.

to m qm, oo po p jm. W -

o p j-o mo oo. t om k nnePmp o oo m, w mpm- opmo o p ooo. W m w pp p o d o expm (doe).

B o mpom, om q 30 p mpom mopo .

SPECiiCATiON AND ESTABliSh-MENT O PilOT EquiPMENT

a m m, o o b b o kow om or&d o o poo qk pob o o mjo mpo o poo m.

a nne Pmp, w o xpom poo po opm o ppo oom w o p b po qpm. Po qpm p o m- poo, po .B o o m ompoob -p poo. t po mo, jo-, oo mb.

u po qpm, po o b poo-k o-m. Po qpm o o - poo q -p. c po b ? i o,w po ompo o mk wok.nne Pmp o o owok o w o om r&d o-o. B oo d oM (dFM), F Mo, e, c a (FMeca), d oexpm (doe), v c a co Mo w b r&d po-o o. O o w ppo q, poo poo po, po o p. i , w m o o o omw m m poo qpm op b p o 30p.

eb po qpm mjom o poo

p.

o q o po w o b b bqpo .

t k-b ppo ow 820 gMP. W po ow ow w o oow o o p p xo o q k mo x pom o -q o o po oo.

AIs process

outputverifiable

BIs verificationsufficient andcost-effective

D

ValidateE

Redesignproduct and/or

process

CVerify andcontrol the

process

Yes

No No

Yes

Process adaton decson tree


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o po o poo po, mo pb o poj w b.

a nne Pmp, w o , o w w woko w o o mxmmpb w o k m oo,

Fta (F t a) FMeca(F Mo, e c a) o xp om w o poj.

ASSESSiNG MEDiCAl DEviCECMO ENviRONMENTS

i mpo o b oopo w o m x om po opm omk nne Pmp p.

O o o om w ook o o m o m .t k o m o owo oo o p woo o o m. Oom o po-o qpm m p o q, o m o o opm, b poj p o o mm poj k.

W wok o o w oom po o m- o q o po-o p, po qp. O o w o q po omo oob , poo qpm -

m, po o poj xop.

d po, w o o om-mo o o om- oo p opm pm. a w m w om w , om nne Pmp o oow p o o m b.

Customer Equipmentsupplier

Componentsupplier

CMOknowledge

Projectmanagement

CMO

Drugsupplier

RiSk ASSESSMENT OPRODuCTS AND PRODuCTiON

i oo bw o m o po o m po? doo poo p k p?

h o o po oo o poo po?

t o po oo k o o qo o m . too w pooo ob wok,w oo m po oo o o. i o poo po- q m po oo, mb pob o mpo o oompo. t mo o kow bo

GlOBAl TRANSER OTEChNOlOGy AND EquiPMENT

a om po, o omp w pobb o po-o qpm kow o w. Pp o o -ppoo om po o o -, ob poo .O mb o w o mo pooo o o om o o poo o ow o o b. O mb mo w b o mm bo w m o.

a nne Pmp, w o obp o ppo o o . O mpp

o--pp o oo o n P vo o opo; o mp x poo p m o po-o pm, op po,qpm o. W o ompp o ompo pofow m o o. a w bo m oo o qpm mpo qpm. i -o w o o p w -b qpm, osOP (s Op Po).


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DESiGN PlATORMS ANDlExiBlE PRODuCTiON lAyOuTS

M m m q fxb o m m o mp ppo. to opw , nne Pmp wokw pom op opmpoo o o o o qqm. t m m -ppoo w p fxb, o ow- poo w o m-om o m bmbo.

W k o o oo opoo o b pp mo moo o o -o o w , o xmp b p- o o w o. ao, o b o fxb, o w o z o b o p ow o mp ow po-mm o w ompo.

EquiPMENT SuPPliERRECOMMENDATiON

a ow o o o owp oo poo qpm k p- w wo- pp. a nnePmp, w wok qpmbkow o qpm pp o op poo .

W pp o ob m gob spp l, w o b o pp omo.W pp o w m w om, oowb om pp , w om bk w o po ommo.

W o b o pom qoo pp qpm, k o m o q o omo gMP-.

W xp bo w omo bm o w poo mp o x o,k qpm po ppo o poo qpm jo mo, p, opo qpm, oo, mb,pk o.

DATA-DRivEN PRODuCTDEvElOPMENT

to poo om m- b k pom o (KPi) , owm, p cO

2

mo. top mm m

pb o po op-m poj. i , KPi poom o po -opm om. do mkw o kow bo, o xmp, mb o poj mo m o- o po w mm. t o w o kow owm opm poj po- , o ow m o po mpo om omp .t o o.

a nne Pmp, w omp- o mpm - o po opm o o ppo opm o o, mp o- op w owop mm b.W o b oo k d o

M (dFM), po k -m (Fta & FMeca), d o sx sm d o expm (doe).

t o mo o oo m. how, m-om, o po mp xpm k o bomo. u doe, w -o mo o opm. W o wok o w

o w o po q p o po opm omp-.

STREAMliNiNG Gl

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