Human-plasma derived cGMP albumin optimized for cell therapy manufacturing.

Akron’s Human Serum Albumin (HSA) 25% Closed System Solutions™ (CSS) is manufactured, tested, and released following relevant cGMP guidelines for blood-derived ancillary materials. The HSA substance is supported by a Type II Master File (MF) on file with the FDA which can be referenced during your drug or biologic application process. Akron’s HSA 25% CSS is specifically formulated for sterile closed-system cell and gene therapy commercial manufacturing.

HSA 25% CSS uses raw material sourced from US donors, collected in FDA-licensed facilities adhering to all donor screening and virus testing legislation set forth in US 21 CFR 610. Redundant pathogen testing occurs during the manufacturing process to ensure safety. Akron’s HSA 25% CSS solution does not contain stabilizers typically found in other pharmaceutical albumin solutions. Because these substances (caprylate & acetyltryptophanate) have been shown to interfere with relevant cell culture, their exclusion allows for an HSA supplement that promotes optimal cell culture performance for the human cell therapy industry. Akron’s cGMP HSA 25% CSS can be used in a wide range of applications such as cell culture supplementation, assay standardization, protein stabilization, and product formulation.

The HSA 25% CSS product is packaged in a sterile single-use bag with weldable tubing, allowing for easy incorporation into modern closed-system cell culture bioprocessing protocols. HSA 25% CSS increases safety and ease of use by allowing for the introduction of supplement material into culture media in a fully contained manner. The final product undergoes Endotoxin, Mycoplasma, and Sterility testing.