Post on 09-Apr-2018
8/8/2019 Scale Up & cGMP Manufacturing
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Scale Up & cGMP ManufacturingYou have taken your drug candidate as ar as you can. It
is time to scale up your process rom the bench to clinical
or commercial size batches. But is your process robust
enough? Will it stand up to a 5, 10, 50 or 100 times scale up?
Who can you turn to or protein and antibody scale up and
cGMP manuacturing experience? Therapure is your trusted
partner who can meet your process scale up and cGMP
manuacturing needs.
Therapure Biopharma operates a 130,000 t2 world-class
acility with over 28,000 t2 o cGMP manuacturing space.
Operating a range o classied suites rom Grade A
(Class 100:ISO 5) through Grade C (Class 100,000:ISO 8),
Therapure maintains utilities compliant to USP and EP
including Water or Injection, Puried Water, Clean Steam
and Oil-Free Compressed Air.
During process scale up, Therapure keeps its clients
engaged in the project, actively soliciting decisions onraw materials, components, consumables, process
specic Standard Operating Procedures (SOPs), Batch
Production Records, Analytical Test Methods, Product
Specications and Process Flow Diagrams. We work as
an extension o your organization, adding value as your
trusted manuacturing partner. When batch manuacturing
starts, we encourage clients to be onsite, observing the
manuacturing runs with us. Upon completion, we review
the run with the client, going through every technical aspec
o the batch records in order to ne tune the process orthe next run.
Therapure has experience utilizing a variety
of different sources of API including:
nWhole Blood and Plasma
nMammalian Cell Culture
n Primary Cell Culture
Scale Up & cGMP Manuactur
8/8/2019 Scale Up & cGMP Manufacturing
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Highlights of our manufacturing capabilities and capacities:
Tissue Processing
n Dedicated Grade C (Class 100,000:ISO 8)
suites through congurable HVAC systems
Protein Manufacturing
Upstream
nMammalian cell culture processes (CHO,
HEK-293, Hybridoma, etc.)
nMicrobial processes (through strategic partnerships)
nMaster Cell Bank (MCB) creation
n Seed train rom 5L to 500L Single Use Bioreactors
(SUBs)
nMedia preparation up to 6,000L batches
Midstream
n Harvest by nominal fow ltration, tangential fow
ltration or centriugation
n Viral inactivation tanks (pH, solvent-detergent,temperature)
n Nanoltration
Downstream
n Dedicated ‘non-live’ processing area
n Chromatographic volumetric rates rom 10mL/min
to 10L/min
n Ultraltration / dialtration up to 100 m2 o membrane
n Protein modication (conjugation, reolding,
enzymatic conversion, etc.)
n Buer preparation up to 6,000L batches
n Bulk lling Therapure Biopharma Inc. 2585 Meadowpine Boulevard,
Mississauga, Ontario Canada L5N 8H9
Telephone: +1 905 286 6200
Fax: +1 905 286 6300
www.therapurebio.com
your trusted partner for contract protein development & manufacturing