Gene Therapy Facility CQV Checklist

With the boom in gene therapy demand and production over the last decade, biopharma manufacturers are continually adapting to capitalize on market trends and address necessary equipment and facility upgrades.

The increase in regional cell and gene therapy manufacturing has brought a diverse set of production requirements to life sciences clusters throughout the United States, with the need for specialized, high-tech genetic engineering systems and capacity limitations dictating facility expansions and repurposing.

Gene Therapy Progress and Challenges

At this year’s ISPE-CaSA (Carolina South Atlantic Chapter) Annual Life Sciences Technology Conference, we heard from several experienced, talented, and respected keynote speakers on topics related to the progress and challenges of gene therapy production.

The CaSA conference was a true representation of how scientists, academics, engineers, and manufacturers are working together to solve the complexities surrounding gene therapy innovations and go-to-market strategies.

While the innovations in gene therapy are exciting and moving at a breakneck pace, the regulations, technology, and infrastructure requirements for manufacturing are evolving just as quickly.

CQV Checklist for Gene Therapy Facilities

CQV Checklist for Gene Therapy Facilities

Are you involved in the engineering, quality management, validation, or risk management of a greenfield or brownfield gene therapy project? Whether this is your company’s first gene therapy buildout or not, each is unique and involves specialized knowledge and procedures to ensure the project is completed on time and within budget.

Read our executive brief to learn about commissioning, qualification, and validation considerations for gene therapy production facilities.

Get It Done Right: Contact ICQ to Get Started

Want to discuss your upcoming gene therapy facility project? Get in touch with our CQV experts today.