Blood-Free Recombinant Albumin

Molecular structure iStock-1263966452

InVitria’s rHSA is derived from a non-mammalian expression system and is Blood-Free and chemically defined.  Blood-Free is a term InVitria applies to its products to add clarity and eliminate confusion about the sources and inherent nature of albumin products.

Blood-Free simply means the components are not derived from, processed with, or packaged in any serum, animal, human, or other blood source.  InVitria’s albumin eliminates adventitious agents stemming from mammalian derived serum and serum proteins, improving patient safety and treatment efficacy. InVitria produces three different rHSA products optimized for different applications:

  • Cellastim S® has been optimized for cell culture applications. It is a recombinant human serum albumin manufactured in a completely mammalian free expression system in a tertiary animal-free production environment. It has been used in countless cell culturing applications and media formulations to provide the qualities of albumin discussed above while eliminating the risks and inefficiencies inherent in animal- and human-derived components.
  • Exbumin™ is the first FDA- and EMA-approved recombinant albumin excipient. This cGMP grade rHSA has been formulated specifically for production environments up to and including the final formulation of biologics. This supports applications in vaccine development and manufacturing, biological formularies, surgical adhesives, medical devices, and regenerative medicine.
  • Optibumin®, the highest purity albumin available, has a lipid-stripped, high-mercaptoalbumin profile, optimizing the binding properties of the albumin. The high-purity nature of this rHSA product makes it uniquely suited for biopharmaceutical formularies, surgical adhesives, medical devices, small molecules, diluents, and in vitro fertilization optimization.

Albumin is a naturally occurring protein in animals and humans responsible for aiding in numerous cellular functions and is integral to the manufacturing of biopharmaceuticals. The various benefits include serving as an antioxidant, mitigating shear stress, controlling adsorption, increasing solubility, promoting transport and binding, among many others.

While this renders albumin as a nearly ubiquitous component used across biotechnology applications, it has historically been sourced from bovine and human donors, wherein albumin is purified from those donor’s blood serum. Eliminating serum and serum-derived components has become an even more pressing matter as regulatory agencies are currently encouraging the use of non-animal derived substitutes. Beyond regulatory suggestions, serum and serum proteins pose risk of contamination via pathogenic adventitious agents, supply chain constraints with increasing demand and deteriorating supply, and therapeutic variability as lot-to-lot inconsistencies translate to inconsistent manufacturing and product purity.

As noted above, we have a range of Blood-Free rHSA products suited for many different processes and uses, from cell culturing to antioxidant stabilization to medical device coatings and everything in-between.  Contact us to learn more about how one or more of these products can help optimize your process.