CryoSolve™

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
• Syringe volume: 8.20 ± 0.10 mL or 7.20 ± 0.10 mL
• Syringe volume: 8.20 ± 0.10 mL or 7.20 ± 0.10 mL
• Syringe diameter: 14.25 mm ± 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
• EP 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal 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

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.

Certificate of Analysis (CoA)
TSE/BSE Statement
Certificate of Origin (CoO)
Safety Data Sheet (SDS)
Product Page

• Appearance
• pH
• Osmolality
• Identification
• Purity
• Cytotoxicity
• Mycoplasma
• Bacterial Endotoxins
• Sterility