Analytical Development for GMP Viral Vector Production – CQA (Safety and Stability)
The complex nature of viral vectors and gene therapies poses challenges in achieving consistency, stability, and safety. Analytical development (AD) is crucial for overcoming these challenges and ensuring the highest quality viral vector product for effective gene therapies. While the industry discusses standardizing analytical methods, achieving this remains a goal due to the high variability introduced by specific engineering for individual therapies. Despite the time needed for standardization, a well-conducted AD process can significantly reduce production risks, making it a vital component in the gene therapy development and commercialization roadmap. Key considerations include defining critical quality attributes, establishing comparability, and minimizing analytical variability through method validation.