Analytical Development

LTD.WUXIAPPTEC.COMAnalytical Service Unit

WuXi AppTec’s Analytical Service Unit provides analytical

development services for early to late phase programs including

API and drug product release, manufacturing support, IND-

enabling stability studies, reference standard qualification and

impurity/degradation product characterization.

Regulatory Inspections• FDA inspection – March 2014

• MPA inspection – April 2013 & Nov 2009

• CFDA inspection – July 2015 (every year since 2012)

• 100+ client-initiated audits from the US, EU and Japan

since 2006

• Continuous systematic training regimen in analytical

sciences, GMP compliance and workflow operations for

all employees

Service Scope• Method development, validation and transfer for use in

regulatory submissions (API and drug product)

• GMP/GLP release of early phase APIs

• GMP release of late phase and commercial APIs and

drug products

• Drug product manufacturing support

• Impurity/degradation product characterization

Full CMC packages for IND submission are composed by a dedicated technical writing group• For global and China submission

• Standalone CMC packages for IND and NDA

• Regulatory consulting

• Extraction and compilation of information from reports from WuXi

or third parties

• CTA/CTD format ready for filing

• Version controls implemented for easy traceability

• Translation service from English to Chinese or Chinese to English

Regulatory CMC

ASU

2015

09F3

U.S./EuropeTel: +1(651) 675 2000 +1 (888) 794 0077Email: ASU_PMI@wuxiapptec.com

ShanghaiTel: +86 (21) 5046 2477Fax: +86 (21) 5046 1000Email: ASU_PMI@wuxiapptec.com

Contact us

Successful Case Studies

Case 1 - Regulatory CMC filing to the FDA and CFDA for a CTD (category 1.1)

• API development and manufacturing performed at WuXi

• Formulation development and CTM manufacture performed at

WuXi

• Analytical development including API stability and CTM

performed at WuXi

• Regulatory CMC documentation and regulatory consulting ,

assistance in site auditing and regulatory inspection performed

at WuXi

Timeline

• The CMC documentation and regulatory data were completed

simultaneously

Value• Dedicated documentation specialist and experienced

reviewer

• Integrated with API development and manufacture,

formulation development and CTM manufacture,

a n a l y t i c a l d e v e l o p m e n t a n d r e g u l a t o r y C M C

documentation to expedite the clients development

timeline

• WuXi’s in-depth understanding of global and local

regulatory guidelines and successful submission

experience enabled us to assist the client in developing

and implementing an R&D strategy.

Case 2 - FTE-based strategic collaboration for IND‐enabling and late phase programs

• API & drug product analytical packages prepared for IND/CTA

submission

• Integrated a plan for phase I CMC development and

manufacture for 8 compounds in a year

• Calibration for reference standard

• Confirmed compound structure for IND submission

• Stability excursion study for the reference standard for

marketed & development products

• Late phase API and formulation development

Timeline

• Average 4‐6 month from project initiation to CTM delivery with

completed analytical packages

Value

• Large capacity adding flexibility to our client’s projects

• Fully integrated CMC services reduced the development

timeline

• Leveraged knowledge from API development for formulated

products to expedite impurity control

• Service integration saved time and 30‐40% of the total cost