Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage

By Abigail Hisler Director of Strategic Marketing, Global Biologics, West Pharmaceutical Services, Inc.

Recently, there has been a surge of activity in the area of cell and gene therapies, 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.

As more of these life changing therapies are granted, accelerated approvals and the speed of development increases, it is critical to plan for your packaging decisions early in the development cycle to avoid potential delays.

Learn more about a biotechnology company with a recently approved gene therapy product that partnered with West to select a packaging solution that would allow them to meet their needs for storage at low temperatures and still get to market quickly.