wuxi apptec’s analytical service unit provides...
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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: [email protected]
ShanghaiTel: +86 (21) 5046 2477Fax: +86 (21) 5046 1000Email: [email protected]
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