Each batch of cell and gene therapy product is a massive financial and logistical investment that patients are depending on, so it’s critical that manufacturers get it right at every step, including their choice of containers for bulk drug substances.
A U.S.-based biopharmaceutical company with a significant emphasis on AAV-based gene therapies was looking for a storage solution for bulk drug substances in their relatively new gene therapy applications. Though these substances are not the final processed material, they are still the product of a huge investment of time, money, and specialized effort, making any container breach a significant loss. The Company’s choice would have to ensure that every drop could ultimately reach patients in a safe and sterile fashion.
An early interest in the capabilities of Flexible Freeze products by the leader in Pharmaceutical Development at the Company was shared with his colleagues. The visual impact of a video showing a Flexible Freeze bag being dropped while frozen without any breakage or leaking gave a striking positive impression. Continue reading to learn how the company has not only selected the right product for their needs by choosing to use Flexible Freeze containers, but the right service partner as well.