DMSO

DMSO: An effective cryoprotectant with several safety issues

The traditional compound for cryopreservation has for decades been dimethyl sulfoxide. This organic solvent, even though well-known to most in the cryopreservation area, has a number of short-comings:

  • Reports of severe adverse reactions, such as cardiac or respiratory arrest, neurotoxicity and epileptic seizures 1

    • From the USP: DMSO is associated with risk of predictable dose-dependent gastrointestinal, cardiovascular, and neurologic toxicities that typically are ascribed to histamine release 2

  • Changes in the cellular epigenetic state

    • DMSO shown to induce hydroxymethylation (5hmC)  and reduce methylation (5mC) in pre-osteoblastic MC3T3-E1 cells 2

    • Increase expression and activity of de novo methyltransferase 3

    • Directly cause methylation of cytosine 4

  • Strong and unpleasant smell which is a nuisance for staff, patients, and their surroundings

    • From the USP: DMSO is categorized by ICH as a Class 3 (relatively low risk) solvent or excipient in pharmaceutical products, and amounts of up to 50 mg/day, or less, are considered acceptable without justification (see ICH Q3C) 2 Cryopreserved cellular products frequently contain 10–20 times this amount unless they are washed after thawing.

  • Requests from regulators for alternatives 5

1. Gao d. et al. Bone Marrow Transplant. 2014 Apr;49(4):469-76      
2. From the USP 38 <1044> "Cryopreservation of cells" (p. 827)         
3. Kung A.W.C et al. FEBS Lett. 2006 Jan 9;580(1):121-6
4. Robertson K.D. et al. Bioorg Chem. 2004 Aug;32(4):234-43
5. Kasai H. et al. Bioorg Med Chem Lett. 2010 Jan 1;20(1):260-5
6. Cox M.A., et al. Cell Tiss Bank, 2012, 13(2):203-15

 

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)

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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

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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).