Viral vector commercialization – Part 2:

Best practices in process validation lifecycle

May 17, 2023 by Staff writer (9 minute read)

Viral vectors are a critical component in gene therapy, gene-modified cell therapy, and vaccine development, offering immense potential to revolutionize medical treatments. However, ensuring the safety, efficacy, and quality of viral vectors requires a robust validation lifecycle with various assessments and studies. The validation lifecycle establishes a strong foundation for the successful translation of viral vector-based therapies from the laboratory to the clinic, and is comprised of three stages:

Stage 1: Process definition