Translating innovative cell therapies: What is GMP?
The cell therapy sector is growing rapidly and within it, cell-based therapies derived from human pluripotent stem cells (hPSCs) are on the rise. The translation of pre-clinical research to clinical trials requires ‘Good Manufacturing Process’ (GMP) to ensure emerging therapies are safe.
Cell-based therapies are complex precision drugs based on cutting edge science and the manufacturing process is a crucial part of the value chain for these products. Therefore, getting the manufacturing piece right is a major part of the translation and commercialisation of cell-based products.
When it comes to therapies in which living cells are the final product- how can safety of the final product be defined? Unlike biologics and pharmaceuticals, cell-based products cannot be purified, filtered, or sterilized to eliminate contaminants. Therefore, safety is closely tied to control of the manufacturing process and the reduction and mitigation of risk.
So, what is GMP, and how will the requirement of GMP impact hPSC-derived therapies?
GMP is a system of controls by which products are manufactured to ensure they are safe for use in humans. GMP covers all aspects of manufacturing to generate a product; the environment in which products are manufactured, the technologies and equipment that are used, specific gowning required for personnel in the manufacturing suites, the documentation that tracks the manufacturing process, all materials used in manufacturing, analytical testing, and more. These controls are implemented by manufacturing facilities and enforced by regulatory agencies to ensure that products consistently and reliably meet safety and quality standards.
Researchers often underestimate, or simply do not know, the effort required to develop a GMP-manufacturable cell therapy product. It is important to acknowledge that research labs generally will not have the proper quality or control systems required to make a product safe for humans, nor the Good Documentation Practices (GDP) which includes batch records and traceability for all materials and equipment used in the manufacturing process. And this is OK! GMP cell therapy manufacturing facilities exist for this purpose.
GMP manufacturing facilities focus on controlled production of cell-based therapies. They house the GMP qualified technologies and equipment, as well as the expertise to manufacture cell-based therapies for clinical trials in alignment with regulatory body standards.
GMP is inextricably linked to the cell therapy space. How can scientists and clinicians navigate the regulatory requirements for translating cell-based therapies to the clinic? And how does the work undertaken at Cell Therapies Pty Ltd’s GMP manufacturing facility support these activities? This blog series will further explore all this and more. We encourage our audience to stay tuned.
This article and its intellectual property were written by Jennifer Hollands in conjunction with Cell Therapies marketing.