Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based Strategies

March 16, 2021
Saroj Ramdas

Saroj Ramdas is GSK fellow and director, CMC regulatory strategy and advocacy with GlaxoSmithKline.

,
Renata Varga

Renata Varga is principal scientist, Teva Branded Pharmaceutical Products R&D, Inc.

,
Martin Gastens

Martin Gastens is senior director program management, AbbVie Deutschland GmbH & Co. KG.

,
Twinkle R. Christian

Twinkle R. Christian is process development scientist at Amgen.

,
Bharat Jagannathan

Bharat Jagannathan is process development senior scientist at Amgen.

,
Barbara Rellahan

Barbara Rellahan, rellahan@amgen.com, is director, product quality, at Amgen.

,
Jillian Brady

Jillian Brady is manager, science, regulation & policy, Faegre Drinker Biddle & Reath LLP.

BioPharm International, BioPharm International-03-15-2021, Volume 2021 eBook, Issue 1
Pages: 23–26

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.

Read this article in BioPharm International's Regulatory Sourcebook March 2021 eBook.

About the authors

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*, rellahan@amgen.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.

Article Details

BioPharm International
eBook: Regulatory Sourcebook, March 2021
March 2021
Pages: 23–26

Citation

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).