cGMP CryoSolutions™ 100%
Simple. Clean. Pure. DMSO.
Akron’s CryoSolutions™ 100% product is manufactured following all relevant cGMP guidelines for ancillary materials. The formulation contains sterile, filtered DMSO (Dimethyl Sulfoxide, USP/EP), highest purity grade >99.99%. Post-thaw viability is comparable or superior to the leading DMSO-containing cryomedia. Our CryoSolutions™ 100%, DMSO solution allows for flexibility when using multiple dilutions or working with a variety of cells and tissues.
Sterility and Bacterial Endotoxin testing are performed per USP/EP on the final product. Our cryopreservation media is packaged in glass vials and available in a 100 mL aliquot. Akron’s cGMP-compliant CryoSolutions™ 100% is intended for cryopreservation of biological cells in cell culture, stem cells, mammalian cells and biological tissues.
Raw Material
• Negligible BSE/TSE risk from all media components
• Low Endotoxin (≤ 1 EU/μg)
• High Purity (≥ 97%)
Manufacturing
• Manufactured in compliance with cGMP guidelines
• No animal-derived materials are used in the manufacture of this product
• Packaged in vials made from borosilicate glass USP Type I
• Septum stoppers and flip-off seals – certified, sterilized - designed for aseptic operations
Quality
• Relevant cGMP Guidelines Used in Manufacture, Testing, and Release
• USP <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
• ISO 13485:2016, Medical devices - Quality Management Systems - Requirements for Regulatory Purposes
• ISO/TS 20399-1-3:2018, Biotechnology - Ancillary Materials Present During the Production of Cellular Therapeutic Products
• High Purity, Low Endotoxin - Endotoxin and Sterility testing per USP/EP
Stability
• Store at room temperature
• Transport ambient
For Use Statement
For research use or further manufacturing use in ex vivo cell therapy applications. This product is not intended for direct in vivo use or for direct clinical use as a drug, therapeutic, biologic, or medical device.
• Appearance
• Acidity
• Water %
• UV Absorbance (270-350 nm)
• Identification (IR)
• Identification (Chemical)
• Refractive Index (at 25 °C)
• Specific Gravity (at 25 °C)
• Freezing Point
• Limit of Non-Volatile Residue
• Purity (anhydrous basis)
• Related Substances
• Bacterial Endotoxins
• Sterility
Aliquot Sizes & Formats
Vials (100 mL) Cat # AK8899-0100
