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July 27, 2020

Packaging Containment Solutions for Cell and Gene Therapies

Research in the area of cell and gene therapies started almost 40 years ago, however recently there has been a surge of activity including landmark regulatory approvals for therapies treating chronic and rare diseases. In 2017 and 2018 the FDA approved the first two CART-T cell therapies for cancer treatment and the first two gene therapies for rare diseases. All four of these cell and gene therapies were approved under the FDA Accelerated Approval Program, aimed at expediting approvals for life saving drug therapies. These regulatory programs have the potential to shorten drug development as much as 1-3 years. Currently, there are more than 1,000 regenerative medicine clinical trials underway globally<sup>1</sup>, and the market is expected to grow rapidly over the next 10+ years.
Abigail Hisler

Abigail Hisler

Director, Strategic Marketing, Biologics


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