A collaborative approach to viral vector development and manufacturing

September 6, 2023 by Staff writer (7 minute read)

The gene therapy market size was valued at $1.55 billion in 2021, and it’s projected to grow to $10.1 billion by 2032 — with North America leading the charge. But to successfully treat and/or prevent rare, genetic diseases, gene therapies require viral vectors, which are “delivery vehicles that have allowed researchers and clinicians to develop powerful drug platforms, and have radically changed the face of medicine.”

That said, the development and large-scale manufacturing of viral vectors from discovery to commercialization is a complicated endeavor with many moving parts, and it requires key deliverables and considerations, including:

  • Industry expertise and robust process design
  • Supply chain and technology platform planning
  • Scalability and manufacturing capacity
  • Regulatory and clinical strategy
  • Market access approach

Additionally, there are many challenges that biotechnology and pharmaceutical companies must overcome, such as:

  • Access to manufacturing talent and capacity
  • Ability to scale and standardize methods
  • Reproducible product quality and safety data
  • Raw material supply and quality considerations
  • Regulatory compliance in a revolving environment

Today’s biotechnology and pharmaceutical companies can choose to tackle viral vector development and manufacturing on their own, or they may opt to outsource crucial tasks to third-party CDMOs instead of relying on their in-house resources. By doing so, they stand to realize benefits related to site investments, production timelines, cost savings, quality performance, risk mitigation, and resource allocation.

At Thermo Fisher Scientific, we have 20+ years of viral vector experience supporting a broad range of development and manufacturing platforms. Our end-to-end Quick to Clinic™ program is designed to de-risk and accelerate your gene therapy's journey to market — delivering an all-inclusive solution for your lentivirus and AAV vectors. With 15+ global sites and over 650,000 square feet of development and manufacturing space, we’re well-equipped to handle your viral vector needs and ensure long-term success.

View references
1. Gene therapy Market, Fact.MR, April 2022, https://www.factmr.com/report/4648/gene-therapy-market
2. Viral vector platforms within the gene therapy landscape, Nature, Feb. 8, 2021, https://www.nature.com/articles/s41392-021-00487-6