The expanding field of peptide and protein therapeutics gives promise for improvement of treatments against several diseases. Many of the biopharmaceuticals found to be efficacious continue to face ex vivo instability challenges despite advancements in protein and peptide engineering. In this respect a lot of the drug development efforts are devoted to pre-formulation and formulation studies aiming at maximizing the stability of the biopharmaceutical. This is not an easy task and therefore, they form a critical objective of any drug development program.
It is well-known that recombinant human serum albumin can stabilize proteins in solution preventing adsorption, aggregation and oxidation. The stabilizing ability stems from some of the roles albumin performs in blood, such as a carrier of small hydrophobic entities, participation in the control of pH and osmotic pressure and affording the majority of the antioxidant capabilities present in blood. Recombinant human albumin is therefore a promising stabilizer for hard-to-formulate biopharmaceuticals.
In this talk we will illustrate the use of Albumedix® Recombumin®, a recombinant albumin product, as a stabilizing agent for model biopharmaceuticals. We will present data on the use of Recombumin showing its versatility as an advanced excipient.