Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies Proceedings of a Workshop (2017) / Chapter Skim
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6 Potential Next Steps for Supporting the Development, Manufacture, and Regulation of Regenerative Medicine Therapies
6 Potential Next Steps for Supporting the Development, Manufacture, and Regulation of Regenerative Medicine Therapies
Pages 67-76
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From page 67... ...
. These areas included emerging technologies and scientific challenges, developing standards and a regulatory framework, interdisciplinary collaboration, workforce training and management, the role of the patient in the discovery and development process, and planning for the future in the regenerative medicine industry.
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From page 68... ...
• pplying an interdisciplinary approach using mathematics, engineering, and A scientific principles to the discovery and development processes will generate transformative technologies and regenerative medicine therapies. (Kamen)
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From page 69... ...
, FIRST was created to bring industry, universities, parents, teachers, and governments together to create a fun environment in which children, particularly women and groups underrepresented in the STEM fields, would see science and engineering as attractive fields to pursue, said Kamen. The intent is that BioFabUSA will follow a similar growth trajectory as FIRST, resulting in a thriving collaborative effort that will advance innovation in the field of regenerative medicine, he said.
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From page 70... ...
"Along the way, we are going to build a coalition that will be the next big advance in health care." REFLECTIONS AND TAKE-AWAY MESSAGES FROM THE WORKSHOP Scientific Challenges and Emerging Technologies The biggest opportunity to move the field of regenerative medicine manufacturing forward lies in robotics and automation, Anne Plant said. Successful automation would not only help control the manufacturing process and improve the quality of measurements, but would also provide clarity about what parameters affect the clinical potency of a product, she said.
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To move the field forward, researchers and manufacturers must understand that product identity is not potency and that the process is not the product, he said, emphasizing that a list of a product's characteristics does not necessarily indicate its potency and that following a manufacturing protocol does not necessarily yield an effective product. Vanek agreed, adding that it will be vital to improve techniques for characterization, process development, and assay development for measuring comparability.
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FDA has provided tremendous assistance to the biotechnology industry as biological therapies such as monoclonal antibodies were developed, even before the science of these therapies was well understood, Siegel said, citing FDA's mission statement that includes the responsibility to "advance public health by helping to speed innovations that make medical products more effective, safer, and more affordable by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health."2 Cell therapy is following a similar pathway to that of monoclonal antibodies, Siegel said, adding that his hope is that it will lead to improved manufacturing processes, more automation and standardization, and a detailed understanding of the CQAs that will accelerate the process of bringing products to market. In addition, he said, the ongoing efforts to create standards and invest in the science and automation will get the field to where it can generate therapies much faster.
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From page 73... ...
It will be important to engage the STEM community and instill a sense of ownership and passion for this work, Vanek continued, and it will require companies to think creatively about the range of skill sets and expertise levels needed to support the manufacturing process. The manufacturing environment is challenging, Preti added, and advancing the potential for companies to develop innovative products will be dependent on bringing together individuals with the right expertise rather than on relying on generalists to carry out the full development process.
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Once the field starts prioritizing collaboration and applying a design framework to the development and manufacturing processes, he predicted, progress will accelerate to a degree that it will take a mere 20 years for regenerative medicine to become a dominant part of therapeutics.
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From page 75... ...
"From the regulatory perspective," he said, "we whole-heartedly agree that [science-based approaches] should guide us as we move forward with any of the manufacturing problems we want to deal with in this regenerative medicine therapy product space." There are differences in the ways that regulatory agencies around the world think about manufacturing processes and quality assurance, and in turn, how manufacturers approach their processes as a result of these differences, Oh said, agreeing that the field needs to consider how to narrow those existing gaps between regulators and manufacturers.
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