Recombumin® Product Portfolio

Recombumin® Product Specifications:

• The Recombumin® product portfolio are world leading recombinant human albumins (rAlb)
• We use our 30 years experience with albumin to offer ongoing regulatory and technical guidance to customers globally
• Recombumin is the highest quality animal origin-free rAlb product commercially available
• Produced at ICH Q7 cGMP Quality
• Produced in Saccharomyces cerevisiae 
• Product form: liquid
• 50ml vial or 1L BPC (dependent on product)
• Internationally recognized by leading regulatory authorities
• Recombumin is used in the manufacture of approved biopharmaceuticals and medical devices (Pipeline).

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Introduction to Recombumin

When developing an advanced therapy or biopharmaceutical drug, whether a vaccine, cell or gene therapy, protein or peptide or medical device, 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 development and formulation strategy. Albumin is a multi-functional excipient and its stabilization properties have been validated through its long-established use in multiple marketed products. Especially within advanced therapies we are experiencing an increased need to include more defined, consistent, animal free, safe and better performing products.

As a customer with Albumedix you do not only get a high quality product, but our team of experts is ready to help you in the application and documentation as well. Contact us to learn more about how we can help you.  

Functional benefits of recombinant human albumin 

From production to patient use, advanced therapies and 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, cell and gene therapy products from aggregation, surface adsorption, oxidation, precipitation and apoptosis among other things.

Adsorption prevention: Recombumin readily adsorbs to both hydrophobic and hydrophilic surfaces in a single mono-layer, preventing non-specific adsorption of advanced therapies and 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. 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 advanced therapies 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), rAlb offers a reliable albumin source with excellent batch-to-batch consistency and security of supply. To learn more about Recombumin, please read our [whitepaper] or watch our on-demand webinar HERE 

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.