BioLife reports increased use of CryoStor and HypoThermosol biopreservation media products in clinical studies

BioLife Solutions, Inc. (NASDAQ: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers ("BioLife" or the "Company"), today reported several new customer disclosures on the use of the Company's CryoStor and HypoThermosol biopreservation media products in pre-clinical validation projects and clinical trials at the recent International Society for Cellular Therapy (ISCT) conference. Several posters citing the use of BioLife products included:

• GSK – poster: Overcoming automation and formulation challenges in the manufacture and distribution of next generation ex vivo gene therapy products.
  • Gene therapy: GSK2696273 - autologous CD34+ cells
  • Clinical indication: SCID due to adenosine deaminase deficiency
  • BioLife products used: CryoStor and HypoThermosol
  • Results: HypoThermosol enabled stability for 7 days and function for 3 days; At days 14, 21, and 28 DMSO and CryoStor were able to maintain CD34 expression

• HemaCare Bioresearch Products & Services – poster: Cryopreserved Leukopaks (LP) Maintain Cell Viability & Functionality.
  • Source material: leukapheresis collections
  • BioLife product used: CryoStor CS10
  • Results: WBC, CD3, and CD14 counts between fresh and frozen/thawed LP were not significantly different; Viability of the cells was greater than 99% in all cases when gated on FSC/PI; Dendritic cell (DC) generation and purity was similar in all cases

• MaSTherCell (for their customer Imcyse) – poster: Technology Transfer and Process Development for an Autologous Cell Therapy Against Multiple Sclerosis.
  • Cell therapy: Sclerolym T cell therapy
  • Clinical indication: Multiple Sclerosis
  • BioLife products used: CryoStor CS5 and CryoStor CS10
  • Results: "Switch to CryoStor solutions dramatically improved survival of mature DC"; "Sclerolym process was scaled-up, developed, and qualified as to allow timely start in phase 1 clinical studies."

• RoosterBio – poster: Cryopreserved hMSC maintain comparable in vitro functional activity compared to fresh hMSC
  • Cellular product: human mesenchymal stem cells
  • BioLife product used: CryoStor CS5
  • Results: Cryopreservation does not affect IDO Induction by IFN-y + TNF-α or Angiogenic Cytokine Secretion Profile

At the ISCT conference, BioLife also presented and demonstrated the evo smart, precision thermal shipper and it's connected, cloud hosted biologistex application which enables customers to pack, ship, and track high-value biologic based payloads including starting material for cell and tissue based products and manufactured cellular and regenerative medicine products and therapies.

A play on the word biologistics (defined as the processes, tools, and data used to monitor and manage the movement of biologic materials such as vaccines, cells, tissues, and organs across time and space), biologistex is poised to disrupt the 50 year old service chain for delivery logistics of biologic based materials through innovative, smart, precision thermal shipping containers and a cloud hosted logistics management application.

Mike Rice, BioLife Solutions President & CEO, remarked on the 2015 ISCT conference by stating, "This ISCT conference was a tremendous success for BioLife by any measure. We learned of several new groups using our biopreservation media products in clinical applications. Traffic at our exhibit was constant throughout the conference, as interest in our new evo smart shipper and cloud hosted biologistex app was very strong. We captured dozens of qualified leads and this event reconfirmed our belief that we have a phenomenal opportunity to help our customer further optimize yield and cost in the manufacturing and delivery logistics of their biologic based therapies, while improving the quality of their distribution practices."