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Many biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
The many challenges of biologic drug development and manufacturing cannot be resolved by a single company, and, because of this, IQ Consortium’s Biologics CMC Leadership Group and 10 other working groups have made it their mission to facilitate the identification of challenges that impede the development and/or commercial manufacture of biologic products, and to propose broadly applicable solutions to proactively advance innovative, science-, and risk-based strategies. Using a platform developed by the Consortium, the entity enables the pre-competitive exchange of information while addressing a variety of these challenges.
Saroj Ramdas is GSK fellow and director, CMC regulatory strategy and advocacy with GlaxoSmithKline; Renata Varga is principal scientist, Teva Branded Pharmaceutical 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*, email@example.com, is director, product quality, all at Amgen; Jillian Brady is manager, science, regulation & policy, Faegre Drinker Biddle & Reath LLP; all authors are members of the IQ Consortium.
*To whom all correspondence should be addressed.
eBook: Regulatory Sourcebook, March 2021
When referring to this article, please cite it as S. Ramdas, et al., “Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based Strategies," BioPharm International Regulatory Sourcebook eBook (March 2021).