Viral vector commercialization – Part 2:

Best practices in process validation lifecycle

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

Category | Advanced therapy

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

  • Process characterization (PC)/process understanding

Stage 2: Process validation

  • PVMP
  • Process performance qualification (PPQ) runs
  • Support PQs

Stage 3: Continued process verification

  • Controlled by trending program
  • Evaluation of process health

We discuss the validation lifecycle stages and best practices for process validation in the video below.

To learn more about preparing viral vector productions for commercialization, check out our full webinar here.