Pharmaceutical Technology - March 2021

Pharmaceutical Technology - Regulatory Sourcebook - March 2021

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36 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2021 P h a r mTe c h . c o m Quality Collaboration T he many challenges of biologic drug development and manufacturing cannot be resolved by a single company. Pre-competitive collaborations have ad- dressed many shared issues, resulting in improved processes to bring therapies to patients. The mission of IQ Consortium Biologics CMC Leadership Group (Bio CMC LG) and its 10 working groups (WGs) is to facilitate the identification of challenges that impede the devel- opment and/or commercial manufacture of biologic products, and to propose broadly applicable solutions to proactively ad- vance 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 quali- ty-by-design principles. In 2019, the LG identified emerging challenges: accelerated product development, global harmo- nization, 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 faced by bio- technology companies and communicated proposed solu- tions through peer-reviewed position papers, conference workshops and presentations (2–8), webinars, and collabora- tion with other industry and stakeholder groups, including regulators (Figure 1). The activities of two working groups—on the safety han- dling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate spec- ifications—illustrate the value of pre-competitve collabora- tive efforts of the IQ Consortium. Biologic drugs and CSTDs in healthcare settings Closed-system transfer devices (CSTDs), when appropriately designed and used, offer enhanced protection to healthcare workers against potential occupational exposure to hazard- ous drugs during clinical preparation and administration. Al- though there has been much focus on CSTDs in the context of Saroj Ramdas, Renata Varga, Martin Gastens, Twinkle R. Christian, Bharat Jagannathan, Barbara Rellahan, and Jillian Brady; all authors are members of the IQ Consortium. PAULISTA - STOCK.ADODE.COM Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based Strategies 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.

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