Pentaisomaltose®

A new golden standard in cryopreservation

Pharmacosmos has for a number of years worked on a carbohydrate-based alternative to DMSO for cryopreservation. We now offer Pentaisomaltose® for testing purposes.

Key Benefits of Pentaisomaltose®:

Clinically Proven Safety Profile

  • Sub-fraction of Dextran 1 – a linear alpha 1-6 oligomer of glucose, average 5 units long
  • Complies with the monographs for Dextran 1 in the European and U.S. Pharmacopeias
  • Dextran 1 has been used for clinical injections for decades as the API in Promit for prevention of anaphylaxis. App. 10 million doses administrated 1983 - 2011 (Ljungström, 1993)
  • Minimizes risk of extractables and leachables as route of entry compared to DMSO
  • Well-defined product, free of animal products

FDA & EMA Approved Production

  • Manufactured at Pharmacosmos’ FDA and EMA approved facility in Denmark
  • Produced under cGMP with strong regulatory supporting data

Regulatory Aspects Well Established

  • Supported by DMF (In preparation)
  • Toxicology data available across broad range of doses

Efficacy as DMSO

  • Efficacy comparable with current golden standard (DMSO) in selected cell types
  • Pentaisomaltose is a non-penetrating cryoprotectant unlike DMSO


Pharmacosmos currently offers Pentaisomaltose® for testing under a Material Transfer Agreement to companies and groups working with cell therapies, or companies interested in commercializing Pentaisomaltose® for the cell therapy industry.

 

Pharmacosmos

Pharmacosmos is one of the world leaders within production and fractionation of carbohydrates in particular Dextran. Pharmacosmos has an unique water-based technology and production platform for polymer fractioning and derivative synthesis.

Approved

Pharmacosmos is the only dextran manufacturer holding certificates from the US FDA and European Directorate for the Quality of Medicines (EDQM)

Quality Delivered

Pharmacosmos delivers a unique dextran quality through a production technology that completely avoids the use of organic solvents and a quality system that meets the strictest cGMP standards for human medicines

Global Service

Pharmacosmos sells and ships directly to clients everywhere in the World. We deliver Pharmaceutical Quality Dextran of the highest standards, including those of the European Pharmacopoeia (EP), the United States Pharmacopoeia (USP), and the Japanese Pharmacopoeia (JP).