CryoSolve®
Cryopreserve your cells.
Perfect for cord blood.
Akron’s CryoSolve® product is manufactured following all relevant cGMP guidelines for ancillary materials. The formulation contains sterile, filtered DMSO (Dimethyl Sulfoxide, USP/EP) and Dextran-40 (USP/EP/JP). Its packaging design (single-use syringe) supports the quality standards for cord blood processing in a closed system. Our CryoSolve® product maximizes the rate of cord blood processing for storage, leading to a notable impact on time and volume.
Aseptic filling is performed after sterile filtration with Endotoxin, Mycoplasma, and Sterility testing performed per USP on the final product. Our cryopreservation media is packaged in syringes and available in 7 mL and 8 mL aliquot sizes. Akron’s cGMP-compliant CryoSolve® product is intended for the cryopreservation of hematopoietic cells in cord blood.
Raw Material
• Component ratio of DMSO 55%, Dextran-40 5%, and WFI (water for injection) 40%
• Raw materials meet Pharmacopeia standards: DMSO (USP/EP) and Dextran-40 (USP/EP/JP)
• All raw materials are compliant, controlled, and traceable under Akron’s Quality Management System (QMS)
Manufacturing
• Manufactured in compliance with cGMP guidelines
• In-house sterile filtration and aseptic filling
• No animal-derived materials are used in the manufacture of this product
• Meets BLA requirements for ancillary materials used in cell therapy product
Packaging
• Packaged in syringes made from borosilicate glass USP Type I
• Luer-lock syringe tip for ease-of-use and eliminates sharps
• All components and packaging meet requirements of low leachables/extractables
• 7 mL syringe volume: 7.11 - 7.73 mL
• 8 mL syringe volume: 8.11 - 8.64 mL
• Syringe inner diameter: 14.25 ± 0.20 mm
• Syringe outer diameter: 17.05 ± 0.20 mm
• Compatible with syringe pump equipment
Quality
• Relevant cGMP guidelines used in manufacture, testing, and release
• USP <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
• ISO 20399:2022, Biotechnology - Ancillary Materials Present During the Production of Cellular Therapeutic Products and Gene Therapy Products
Stability
• 5-year shelf life
• Store at 2-8 °C
• Transport with cold packs
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
• pH
• Osmolality
• Identification
• Purity
• Cytotoxicity
• Mycoplasma
• Bacterial Endotoxins
• Sterility
Aliquot Sizes & Formats
Syringe Kit (7 mL x 25) Cat # AK8217-2507
Syringe Kit (8 mL x 25) Cat # AK8217-2508
