Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies Proceedings of a Workshop (2017) / Chapter Skim
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1 Introduction
1 Introduction
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In addition to relying on scientific experts in the drug and biotech industry, those involved in the research and development of regenerative medicine therapies are increasingly drawing on the unique expertise of regulatory scientists, engineers, physicians, and patients to inform an integrated and efficient development process. Although regenerative medicine has great potential for producing both health and economic benefits, this relatively new field faces unique regulatory and manufacturing challenges.
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Forum members were interested in examining issues related to CQAs for cell-based therapies and also how deep characterization of cells could potentially lead to a more streamlined manufacturing process. Therefore, on June 26, 2017, the Forum on Regenerative Medicine hosted a public workshop in Washington, DC, titled Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies in order to examine and discuss the challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies.4 The goal of the workshop was to learn from existing examples of the manufacturing of early-generation regenerative medicine products and to address how progress could be made in identifying and measuring CQAs.
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Thus, it was hoped that by bringing the regenerative medicine community together to discuss the development of common approaches and standards for crosscutting tools, measurements, functional assays, and manufacturing platforms, the community could identify common challenges and share innovative new practices that might help advance the field and support valuable collaboration. The workshop also addressed the challenges of designing and adhering to standards as a way of helping those who are working to scale up processes and techniques from a research laboratory to the manufacturing environment.
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The incident gave rise to the Biologics Control Act of 1902, which mandated that vaccine producers be licensed annually, undergo regular inspections, and implement new labeling protocols for their products.6 This regulation was followed by the Federal Food and Drugs Act of 1906, which outlawed the production of any foods or drugs that were produced using inferior or impure ingredients or that 6 More information about the Biologics Control Act of 1902 can be found here: https:// history.nih.gov/exhibits/history/docs/page_03.html (accessed August 22, 2017)
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This can only be addressed by controlling the manufacturing process, controlling raw materials, testing donors, and developing standardization processes and reliable assays to characterize the unique markers of consistency, efficiency, and potency for a product, said Siegel. Additional unique factors are spurring the rapid evolution of the regenerative medicine industry, said Claudia Zylberberg, workshop co-chair and the president and chief executive officer of Akron Biotech.
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This chapter discusses methods and processes used to identify and measure CQAs for raw materials and regenerative medicine products. Chapter 4 describes various technologies that facilitate the efficient and cost-effective development of products that meet manufacturing and regulatory standards, and it explores opportunities for new technologies and manufacturing models to increase efficiency and quality.
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