Do you have any recommendations for transitioning from research use products to cGMP produced products in terms of culture?
This question is part of the following Ask The Expert session:
GMP Proteins for Cell Therapy Manufacturing
Job Title: Product Manager
It’s easiest to transition if you can get GMP from the same vendor that supplies your research use only (RUO) protein. Although the manufacturing process and analytical testing is more stringent, there may be very little difference between the proteins in the vials. It is perfectly valid to ask if the manufacturing steps and materials that are used are essentially the same. If a GMP version isn’t available, some vendors will take on a custom project to manufacture your protein using GMP guidelines. Even though the transition should be seamless in these instances, conducting confirmatory testing by repeating experiments should be done. Have a good understanding of what your needs will be if your therapy is successful. The further you are into clinical trials, the more difficult and expensive it is to change. A simple first step is to submit a questionnaire to the supplier’s Quality Department to ensure that they can meet your minimum requirements. Typically there would also be an on-site audit where you could see the facility for yourself and get more detailed information about manufacturing processes. Speak with your colleagues and look for supplier that has experience. The areas of Cell Therapy and regenerative medicine are so new and evolving, an experienced supplier can add value to the relationship.