Integrating Savsu emperature-controlled shipping containers with BioLife’s biopreservation media
BioLife Solutions, which has carved out a specialized niche in providing media to preserve refrigerated or frozen cells, is acquiring the remaining 56% of Savsu that it doesn’t already own. Together, the companies will offer research and commercial biopharma clients a one-stop shop for media and for containers, which range from controlled room-temperature, to refrigerated, to cryogenic. This capability becoming more important as research on cellular and genetic therapies has exploded, and as FDA approves a trickle of new CGT therapies (the latest being AveXis’ Zolgensma [onasemnogene abeparvovac-xioi], a genetic therapy for pediatric spinal muscular dystrophy—a product that Savsu says it was involved in the development of).
Until the CGT field began expanding, most work with cryogenically preserved biomaterials involved the use of traditional dewars, which tend to be heavy, metallic bottles that run the risk of tipping over in transit, which affects their performance. Savsu developed a tailored solution, combined with an IT system to automatically track and monitor a shipment. BioLife and Savsu had announced, in 2015, the Biologistex service for managing the entire shipping process, but that offering appears to have faded away, with the Savsu depending on relationships with several express couriers instead.
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.
Is Compounding the Answer to the Semaglutide Shortage? Experts Weigh In
October 30th 2024In this Q&A, Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, of the Alliance for Pharmacy Compounding discuss the challenges faced by patients and healthcare providers due to drug shortages, particularly for semaglutide and other medications.