Recombumin® - Recombinant human albumin
When developing a biopharmaceutical drug, whether a protein/peptide, vaccine or cell therapy product, it is important to safeguard the activity and safety of the final therapeutic, to ensure patients receive optimal treatment with maximum effect.
This difficult task can be addressed by ensuring an optimized formulation strategy. Albumin is a multi-functional excipient and its stabilization properties have been validated through its long-established use in multiple marketed products.
As the world leader in recombinant human albumin (rAlb), we have developed a portfolio of recombinant human albumin products collectively known as Recombumin®. Manufactured from our proprietary Saccharomyces yeast strains, at ICH Q7 cGMP standards, Recombumin is the highest quality animal origin-free recombinant human albumin product commercially available. Internationally recognized by the leading regulatory authorities, Recombumin is the first and only recombinant human albumin product used in the manufacture of approved biopharmaceuticals and medical devices (Pipeline).
These recombinant human albumin products have been specifically designed to overcome physical and chemical stress of biopharmaceuticals, which cannot be addressed by conventional excipients.
Ensuring drug stability using recombinant human albumin
From production to patient use, biopharmaceuticals face multiple stressful conditions, which may negatively impact its final therapeutic effect. Recombumin is proven as an effective and versatile stabilizer, with the ability to protect protein, peptide, vaccine and cell therapy products from aggregation, surface adsorption, oxidation and precipitation.
|Adsorption prevention: Recombumin readily adsorbs to both hydrophobic and hydrophilic surfaces in a single mono-layer, preventing non-specific adsorption of biopharmaceuticals during manufacture, formulation and storage. Only 1-2 mg Recombumin is needed to coat 1m2 of surface.|
|Aggregation prevention: Through multiple mechanisms, Recombumin prevents aggregation and particle formation of therapeutic proteins and peptides. By dispersing uniformly in a solution, it affords an insulating quality that minimizes physical drug instability.|
|Oxidative stress prevention: Given its natural free thiol group, Recombumin protects biotherapeutics by scavenging against modification through oxidation stress when in formulation.|
Solubilization: Given its highly specific binding pockets and varying polarity, Recombumin possesses some unique solubilization properties, enabling the prevention of precipitation of otherwise poorly soluble small molecules.
Unlike plasma derived human serum albumin (HSA), recombinant human albumin offers a reliable albumin source with excellent batch-to-batch consistency and security of supply. To learn more about Recombumin, please read our whitepapers or watch our on-demand webinar.
Altogether, Recombumin® recombinant human albumin provides a safe and reliable solution that enables the formulation of otherwise unstable drug candidates, giving confidence in your formulation.