Viral vector commercialization – Part 3:

Specialized regulatory support

June 22, 2023 by Staff writer (9 minute read)

Category | Advanced therapy

Specialized regulatory support plays a crucial role in the commercialization of viral vectors, especially considering the accelerated pace of cell and gene therapy product development. As these innovative therapies rapidly progress, it is essential to have regulatory frameworks specifically tailored to the unique challenges posed by viral vectors. Specialized regulations address critical aspects such as vector design, manufacturing processes, safety, and efficacy, ensuring a comprehensive evaluation. By providing clear guidelines and protocols, specialized regulatory support can expedite the approval process without compromising safety standards. This enables timely market access to these promising therapies. In addition, this focused regulatory approach encourages collaboration between regulatory agencies, researchers, and industry stakeholders. This fosters a conducive environment for innovation and the advancement of viral vector-based therapies.

When preparing viral vectors for commercialization, keep these regulatory considerations in mind to mitigate unnecessary risks:

  • Compressed timelines
  • Assay challenges and variability
  • Raw materials using tumorigenic cell lines
  • Limited batches available at commercial scale

We discuss the details of each considerations, as well as best practices for addressing them in the video below.

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