Navigating The Complex Testing Strategies For Viral Vector-Based Gene Therapies

By Robert Cartee, PhD- Senior Director, Biopharmaceutical Services, SGS North America, Inc.

Gene therapy, a promising field in medicine, faces challenges in effectively delivering therapeutic genes into cells. Viral vectors, derived from viruses, have emerged as efficient tools for this purpose. Different viruses, such as adenoviruses and retroviruses, have been engineered to carry therapeutic genes. However, the development and manufacture of viral vector-based gene therapy products require rigorous testing to ensure safety and quality.

Testing includes identity testing to confirm the correct nucleic acid sequence, content/potency testing to determine the amount of infectious viral particles and their ability to infect cells, and quality testing to evaluate physicochemical properties and impurities. Safety testing checks for microbial contaminants and replication-competent viral vectors. Containment closure integrity testing and extractable and leachables testing assess the integrity of the container closure system and potential migration of compounds. Stability testing analyzes the product's potency and quality attributes over time.

Given the complexity of viral vectors and the importance of thorough testing, biopharma companies need to choose a Contract Research Organization (CRO) with expertise in viral vectors and gene therapy. The CRO should possess regulatory knowledge, sufficient capacity, agility, and clear communication to support the development and market release of viral vector products.

To ensure the success of gene therapy, learn why it is crucial to partner with a CRO that can navigate the challenges of viral vector development and testing.