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 with animal- and human-derived components.
- Exbumin™is the first FDA- and EMA-approved recombinant albumin excipient.3 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-mercapto 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 numerous cellular functions and is integral to the manufacturing of biopharmaceuticals. The various benefits include serving as an antioxidant, adding stability to cell culturing, 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. Removal of serum or serum-derived components is essential in a manufacturing setting due to risk of contamination from pathogenic adventitious agents, supply chain constraints due to high demand and limited global supply, and unintended changes to the cell product due variable degree of composition observed in serum. Currently, regulatory agencies are encouraging the use of non-animal derived substitutes.
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.