Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 41 A subsequent white paper illustrates how systematic, risk-based development approaches result in a greater un- derstanding of attribute criticality, method performance, and the potential for the process to impact product qual- ity (7). This white paper outlines critical elements and requirements of commercial specifications and explains how attribute understanding can be combined with ICH Q6B and pharmacopeia requirements to provide f lexi- bility for a growing supply chain demand and lifecycle improvement activities while ensuring the product is safe and efficacious. The WG also communicated their findings at major global industry conferences and workshops (14–19) to drive acceptance and application of the approach outside of IQ, including collaborations with the PhRMA Patient Centric Quality Standards team on commercial specifications (18) and a panel discusison with regulatory representatives. Shared authorship of the publications in the WG limited individual effort but also allowed team reviews and dis- tribution of specific sections to respective subject-matter experts. Importantly diverse cross-company participation in the WG facilitated broader access to case studies from IQ company network and ensured output from the WG represented a broad cross-industry position. The publications and conference presentations of the WG helped close the gap in guidance on how to implement science- and risk-based principles for FIH and commercial mAb and ADC products by providing broadly applicable industry standards. These standards can now be applied across biopharmaceutical companies to further develop- ment and acceptance of the approach. The WG's collabora- tion with PhRMA and inclusion of regulatory representa- tives in the public discussions reinforced that the risk- and science-based approach has widespread industry support and inf luenced current efforts to revise ICH Q6 to incor- porate science and risk-based principles. Conclusion T he Bio CMC LG w i l l cont i nue to strategically focus on emerging CMC challenges that are of high priority to the IQ membership to facilitate rapid, nimble responses that foster innovative, science/data-based solutions to support patient access to critical medicines. References 1. M. Faul, et al., Pharmaceutical Technol- ogy Regulatory Sourcebook, 60–64 (Octo- ber 2020). 2. J. Valliere-Douglas, et al., PDA J Pharm Sci Technol. 73 (6) 622–634 (2019). 3. S. Demmon, et al., Biologicals 67 9–20 (September 2020). 4. P. Wu, et al., PDA J Pharm Sci Technol. 74 (2) 264–274 (2020). 5. M. Hubert, et al., J. Pharm. Sci. 109 830– 844 (2020). 6. J. Kretsinger, et al., J Pharm Sci. 108 (4) 1442–1452 (2019). 7. M. N. Ruesch, et al., J Pharm Sci. 110 771–784 (2021). 8. G. Ganapathy, et al., J. Pharm Sci. in press (2021). 9. ICH, Q6B, Test Procedures and Acceptance Criteria for Bio- technological/Biological Products, Step 4 version (1999). 10. ICH, Q8(R2) Pharmaceutical Development, Step 4 version (2009). 11. ICH, Q9 Quality Risk Management, Step 4 version (2005). 12. ICH, Q10 Pharmaceutical Quality System, Step 4 version (2008). 13. ICH, Q11 Development and Manufacture of Drug Substances, Step 4 version (2012). 14. C. Stroop, CASSS NLab Discussion Group (Oss, Nether- lands, 2019). 15. J. Kretsinger, CASSS WCBP (Washington, DC, 2019). 16. B. Rellahan, IABS 2nd Setting Specifications for Biological Products (Rockville, Md., 2019). 17. B. Rellahan, ISPE Global Pharmaceutical Regulatory Sum- mit. (Rockville, Md., 2019). 18. J. Dobbins, M. Ruesch, and J. Stults, CASSS WCBP Strate- gies for Patient Centric Commercial Specifications Work- shop (Washington, DC, 2020). 19. B. Rellahan, 2020 EU CASSS Strategy Forum (Virtual, 2020). PT About the authors Saroj Ramdas is GSK fellow and director, CMC regula- tory strategy and advocacy with GlaxoSmithKline; Renata Varga is principal scientist, Teva Branded Pharmaceuti- cal Products R&D, Inc; Martin Gastens is senior director program management, AbbVie Deutschland GmbH & Co. KG; Twinkle R. Christian is process development scientist, Bharat Jagannathan is process development senior scientist, and Barbara Rellahan * ,, is director, product quality, all at Amgen; Jillian Brady is manager, sci- ence, regulation & policy, Faegre Drinker Biddle & Reath LLP; all authors are members of the IQ Consortium. * To whom all correspondence should be addressed. Figure 3. Phase-appropriate specifications working group accomplishments and impact.

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