IPQ Special Report — September/October 2008 in Review

THE IMPACT OF QUALITY BY DESIGN ON BIOTECH REGULATION is growing.  An FDA biotech QbD pilot and industry mock initiatives are getting underway that will build on the experience gained in the small molecule area.  In the biotech context, the focus is shifting to the API and the challenges of defining critical quality attributes and design space for these complex molecules and processes.  How to incorporate risk assessments and the role of “expanded change protocols” are other key regulatory filing issues.  The biotech QbD pilot will leverage the growing knowledge base on comparability protocols, which are finding their way from the postapproval arena into NDAs and BLAs and influencing the IND development process.  Industry associations in the U.S. and EU are also focusing on how the new QbD approaches can be applied to analytical methods to strengthen this link in the control chain.


• FDA biotech regulator Cherney on QbD and the new pilot (pp. 6-13)
• Biogen Idec’s Stella on implementing a QbD submission (pp. 20-23)
• CDER’s Winkle on the significance of the Conformia “ACE” mock initiative (p. 26)
• Summary of biotech CMC Strategy Forum on QbD (pp. 31-44)


2……Forum Assesses Biotech QbD Progress
3……Focus Shifts To API And Its Attributes
5……NDA QbD Pilot Leaves Questions
14….Expanded Change Protocols Discussed
16….QbD Regardless Of Regulatory Relief
17….Genentech Spends Time On CQAs
19….Industry Biotech Mocks Underway
24….EMEA Inputs On EFPIA’s MAb Mock
25….Conformia Biotech Mock Follows “ACE”
27….Value of Comparability Protocols Touted
29….QbD For Analytical Methods In Focus

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