BioPharm International - March 2021

BioPharm International - Regulatory Sourcebook - March 2021

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Page 22 of 47 March 2021 eBook BioPharm International 23 Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science and Risk-Based Strategies Collaborative industry efforts address the safe handling of biologic drugs in closed-system transfer devices and phase-appropriate specifications. T he ma ny c ha l lenges of biolog ic d r ug development a nd ma nu fac t u r ing ca n- not be resolved by a single company. Pre- competitive collaborations have addressed many shared issues, resulting in improved processes to bring therapies to patients. T he m ission of IQ C onsor t iu m B iolog ic s C M C Leadership Group (Bio CMC LG) and its 10 working groups (WGs) is to facilitate the identification of chal- lenges that impede the development and/or commer- cial manufacture of biologic products, and to propose broadly applicable solutions to proactively advance innovative, science-, and risk-based strategies. Previous efforts have focused on comparability, cell-line clonality, detection of sequence variants, phase-appropriate specifications, subvisible particles, and application of quality-by-design principles. In 2019, the LG identified emerging challenges: accel- erated product development, global harmonization, and data integrity. Using the Consortium's platform (1), which enables pre-competitive exchange of information, working groups have addressed a variety of challenges being Paulista - Saroj Ramdas, Renata Varga, Martin Gastens, Twinkle R. Christian, Bharat Jagannathan, Barbara Rellahan, and Jillian Brady; all authors are members of the IQ Consortium. Regulatory Sourcebook Quality Collaboration

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