Human AB Serum, Converted from Octaplas®, Pooled Plasma (Human) Xeno-Free, Virus Inactivated

Human AB Serum, Converted from Octaplas®, Pooled Plasma (Human) Xeno-Free, Virus Inactivated

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SKU: AR1010
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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.

Advantages

Raw Material:

  • 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

Manufacturing:

  • 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

Release Testing:

  • Comprehensive metabolic panel
  • USP testing of pH, osmolality, mycoplasma, endotoxin, and sterility
  • For research or further manufacturing use in ex vivo cell therapy applications

Quality Statement

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.

Size

100 ml