Human AB Serum is an ancillary material used in cell therapy manufacturing. It lacks antibodies to blood types A and B antigens and is used to minimize immune reactivity in cell culture. Manufactured using xeno-free components, this product is considered an alternative to Fetal Bovine Serum or other animal-based supplements. Akron’s Human AB Serum leverages Octaplas®, pharmaceutically licensed, virus inactivated plasma as a raw material, offering greater batch-to-batch consistency and a unique safety profile.
- Pharmaceutically licensed, pooled plasma from US licensed plasma donation centers
- Donor screening and viral testing per 21 CFR 610.40
- Donors also undergo NAT testing for HIV, B19, HAV, HBV, HCV, HEV
- Prion reduction step to reduce risk of BSE/TSE transmission
- Inactivation of enveloped viruses by Solvent/Detergent treatment
- Immune neutralization of enveloped and non-enveloped viruses
- Sterile microfiltration minimizes the presence of bacteria and parasites
- No animal derived materials are used in the manufacture of this product, reducing potential for genetic or immunologic incompatibility and decreasing the risk of contamination
- Final product is 0.1µm sterile filtered and filled to 100mL in Nalgene® bottles under aseptic conditions
- Comprehensive metabolic panel
- USP testing of pH, osmolality, mycoplasma, endotoxin, and sterility
- For research or further manufacturing use in ex vivo cell therapy applications
This product is manufactured, tested and released following the relevant cGMP guidelines. Akron follows ISO/TS 20399-1-3. No animal-derived materials were used during manufacturing. USP chapter <1043> Ancillary materials for cell, gene, and tissue engineered products has been considered in the manufacture of this product.