The following is a release from BioLife Solutions, Inc:
Bothell-based BioLife Solutions, Inc. announced on July 15 that manufacturing process validation has commenced to support the launch of a new product, BloodStor 27 NaCl, targeting end user cryopreservation applications including freezing of platelets for clinical administration.
In the US alone, over two million doses of fresh platelets are administered annually. Frozen storage of therapeutic platelets could improve logistics in caring for hemodynamically unstable patients, in situations where fresh platelets are unable to be collected or administered following collection.
“We have been monitoring clinical use of frozen platelets for hemodynamically unstable patients and have been in discussions with leading international clinical centers about the need for a stable supply of GMP manufactured, clinical grade freeze media for freezing therapeutic platelets. Additionally, there is clearly strong interest to improve battlefield trauma care for wounded warriors,” said BioLife Solutions CEO Mike Rice. “We believe that we can add incremental revenue by expanding our product portfolio with this new GMP grade biopreservation media.”
Ongoing military research on the use of frozen and thawed platelets includes a US Army Medical Research and Materiel Command clinical trial titled Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets (CPP1-05), to “evaluate the safety of intravenous (IV) infusion of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) in participants with World Health Organization (WHO) Grade 2 bleed in spite of receiving a transfusion of liquid stored platelets (LSP) in the past 48 hours by collecting adverse events (AEs) and by evaluating coagulation-related parameters to assess the evidence of any thrombotic events after CPP or LSP transfusion.”
BioLife is a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and related cloud hosted biologistics cold chain management appfor smart shippers.
