Table 1.
Commercially available CPAs and excipientsa
| CPA | Supplier | Comments | Web address |
|---|---|---|---|
| Dimethyl sulphoxide (DMSO) | |||
| BloodStor® 100 | Stem Cell Technologies | >99% DMSO, meets USP, manufactured under cGMP quality system compliant to 21 CFR 820 | www.stemcell.com |
| Cryopure™ | OriGen Biomedical | >99% DMSO, meets USP and EP, sterile, aseptic filtered, CE marked under EU Directive 93/42/EEC | www.origen.com |
| cGMP CryoSolutions™ | Akron Biotech | >99% DMSO, meets USP, EP and JP, sterile, meets cGMP guidelines for ancillary materials (USP 1043) | www.akronbiotech.com |
| Cryosure-DMSO | WAK-Chemie Medical GmbH | >99% DMSO, meets USP and EP, sterile mycoplasma-free, aseptic filled under GMP, CE marked under EU Directive 93/42/EEC | www.wak-chemie.net |
| Other cryoprotectant solutions | |||
| CryoStem™ | Biological Industries | Chemically defined, xeno-free, protein-free, containing DMSO and methylcellulose. Sterile, manufactured under ISO13408 in cGMP facility, CE marked for use as an ancillary material in cell and tissue-based therapies | www.bioind.com |
| CryoStor® | StemCell Technologies / BioLife Solutions | Chemically defined, serum-free, animal component-free containing DMSO (2, 5 and 10% versions). Sterile, meets USP, cGMP manufactured under 21 CFR 820 compliant quality system, Drug Master File registered with FDA | www.stemcell.com / www.biolifesolutions.com |
| Stem-CellBanker® | Amsbio / Zenoaq | Available in DMSO and DMSO-free formulations, chemically defined serum-free, xeno-free, meets USP and EP, GMP manufactured, Drug Master File registered with the FDA (MF# 15785) | www.amsbio.com / www.zenoaq.jp |
| Vehicle solutions and alternatives to serum | |||
| HypoThermosol® | FRS BioLife Solutions | Intracellular-type hypothermic storage solution. Serum-free, protein free, sterile, meets USP, cGMP manufactured under 21 CFR 820 compliant quality system, Drug Master File registered with FDA | www.biolifesolutions.com |
| PLTGold® (Clinical Grade) | Biological Industries | Human platelet lysate, serum-free, xeno-free, heparin-free supplement. GMP-manufactured. US donors meeting AATB / FDA eligibility standards. Drug Master File registered with the FDA | www.bioind.com |
| nLiven PRTM | Cook Regentec | Human platelet lysate. Sterile, mycoplasma-free, heparin-free, validated pathogen reduction process, GMP compliant, US donors meeting AATB / FDA eligibility standards | www.cookregentec.com |
| GMP PLUStm | Compass Biomedical | Human platelet lysate. Serum-free, xeno-free, sterile, mycoplasma-free, heparin-free, available in bags, prepared under cGMP, US donors from FDA-registered blood banks. Drug Master File registered with the FDA | www.compassbiomed.com |
a
The list is not intended to be definitive. All information is taken from supplier websites. Only CPAs indicated as intended for use in therapeutic applications are listed.