Human and bovine serum albumin have been integral to cell therapy manufacturing for years given the unique chemical properties and benefits to cell populations during manufacturing. Cell growth and processing solutions utilize albumin for a variety of functions, however, animal and human-derived components pose a serious risk to the safety, quality, and consistency of final drug products. The need for an alternative source is imperative given the proliferation of cell therapy programs.
Recombinant human serum albumin is a safe, consistent, and well-defined alternative to its serum counterpart, facilitating more reliable and scalable cell therapy manufacturing processes. InVitria leverages a plant-based expression system to produce high-quality recombinant albumin at large scale that eliminates the unnecessary risks associated with serum-derived albumin. The highly scalable and sustainable system can respond rapidly to increasing demand while eliminating the risk of adventitious agents. The recombinant technology also removes lot-to-lot inconsistencies, facilitating a more reliable manufacturing process. InVitria’s excipient-grade recombinant human serum albumin, Exbumin™, is the first and only cGMP, excipient recombinant albumin approved for use in biologics by the FDA and EMA. Exbumin can facilitate the replacement of serum-derived albumin in downstream processing formulations and advance innovations in chemically defined, animal-origin-free cell therapy manufacturing.