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 Practice’ (GMP) to ensure investigational therapies are of sufficient quality, so as not to risk patient safety due to contamination or batch inconsistency.
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.
GMP covers all aspects of manufacturing a cell-based therapy, often described as the “5 P’s”: Products, Processes, Premises, People and Procedures.
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.
At Cell Therapies, we are experts in this standard of manufacturing. Our facility houses GMP qualified technologies and equipment, as well as the expertise to manufacture cell-based therapies for clinical trials, in harmony with regulatory standards.
Interested to learn more about how we manufacture GMP-ready products? Explore our facility: celltherapies.com/facility/
Author Notes
This article and its intellectual property were originally written by Dr Jennifer Hollands PhD in conjunction with Cell Therapies, and adapted by Ryan Harding.
