By Sarah Sheridan, Technical Consultant, MilliporeSigma
A vital step in a biologic drug’s path to market is product-release testing, such as for biosafety and characterization, which assures the safety, identity, strength, purity, and quality of a drug product before it is administered to the patient. This comprehensive evaluation of all materials and intermediates used during manufacturing is based on expectations and guidelines developed from decades of knowledge and experience accumulated by the industry and regulatory bodies. As the complexity and diversity of modern biologics increase, the challenges of entering a new frontier in patient care are raising new questions on how to effectively execute these critical activities.
For gene therapies specifically, the regulations and guidances around biosafety testing and characterization are still evolving. In addition, not only is the volume of materials for testing of these products in short supply, but gene therapies must also be administered back to the patient or moved forward for additional processing quickly, limiting the time available for testing.
Therefore, as you consider entry in this exciting market, here are four points to consider when planning product-release testing of your gene therapy product