Article first published in Genetic Engineering and Biotechnology News: https://www.genengnews.com
Considerations for getting started in manufacturing with GMP
Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology they concurrently evaluate whether or not to manufacture the therapies onsite.
A manufacturing transition mandates compliance with current good manufacturing practice (cGMP) to ensure that the treatment is safe and meets quality standards.
“Compliance with governmental regulations is not something you choose to do. It is something you must do if you plan to produce cellular therapies. Although challenging, the process is not difficult. If a laboratory has even an inkling that manufacturing may occur they should start to plan and organize their body of work in a compliant manner,” explains Helen Huls, Ph.D., independent consultant.
“It is never too early to start as regulatory approval is needed before a product can be infused into a patient. All relevant requirements must be met and a safe-to-proceed letter received from the appropriate government authority.”
Enforced by the FDA in the US, cGMP provides a general regulatory framework that ensures the quality of manufactured human drug and biologic products as well as the proper design, control, and monitoring of manufacturing processes and facilities.
The requirements are minimal and purposely flexible in order to allow manufacturers latitude on how to best implement the necessary controls as well as to provide for continual improvement. Similar regulations enforced by other countries and international organizations are typically referred to as GMP.
Following is a guideline of how and when to get started.