Recombinant Human Albumin
Validated Through Application in Clinical and Marketed Therapeutics
The Recombumin® portfolio offers high-quality, animal and human-origin-free recombinant human albumins. Recombumin® is a multifunctional excipient, ancillary, and raw material, and its stabilizing properties have been validated through years of use in multiple life science products. Sartorius Albumedix recombinant albumins provide high purity and consistency, offering a multifunctional ancillary, excipient and raw material that delivers dependable performance.
Scientific Foundation of Recombumin®
Albumin – Designed by Nature, Enhanced by Sartorius Albumedix
With close to four decades of experience working with albumin and its biology, we have only just begun to unlock the vast potential of this unique molecule and its exceptional biological relevance. The structure of albumin gives it excellent stability, making it resilient to environmental stress both outside and inside the body; click the image below to uncover some of the key properties of albumin, and to find out more visit the Albumedix scientific library.
Beyond Evolution. Recombumin®- Albumin Revolution by Design.
Nature, by evolution, has developed a versatile molecule, albumin, with unique characteristics and properties. Through revolutionary approaches, Sartorius-Albumedix has perfected what nature created to enable effective applications of albumin that support the development and commercialization of an array of life science products. These enhancements and the high levels of consistency Recombumin® offers overcomes the limitations that blood derived albumin can present.
Human Serum Albumin (HSA) prepared from plasma presents different genetic variants and exhibits varying degrees of N-terminal truncation, glycation, oxidation and aggregation due to the extracted albumins' extended residence time in the body. Also, albumin is a natural transporter and readily binds to ligands; in blood-derived albumins this intrinsic property however manifests as varied ligand profiles. Unlike HSA, recombinant human albumin (rAlb) products have a remarkably high and consistent quality profile.
Functional Benefits
Delivering Stability While Avoiding Aggregation and Oxidation
During manufacturing, formulation and dosing, advanced therapies and biopharmaceuticals are exposed to stressful, non-natural environments/conditions that may have a detrimental effect on quality/safety, consistency and therapeutic effect.
Recombumin® is an effective and versatile stabilizer for protein, peptide, vaccine, and cell and gene therapy products. It has been proven to ensure a natural micro-environment from lab to arm, protecting biopharmaceuticals against aggregation, particle formation, surface adsorption, chemical degradation, and apoptosis.
Recombumin® Prevents Adsorption
- Readily adsorbs to hydrophobic and hydrophilic surfaces
- Forms a single monolayer
- Prevents nonspecific adsorption
Recombumin® Prevents Aggregation
- Prevents aggregation
- Disperses uniformly in a solution
- Minimizes physical drug instability
Recombumin® Prevents Oxidation
- Scavenges free radicals
- Protects formulations against modification from oxidation stress
In cell therapies Recombumin® goes beyond its three core mechanisms of action:
- Recombumin® transports and forms complexes with metals and molecular entities, forming an optimal microenvironment
- Recombumin® acts as a rich nutrient source, particularly during cell expansion/proliferation
- Recombumin® functions as a pH buffer, preventing unwanted effects during cell differentiation
A Multitool Solution Across Modalities and Applications
Recombumin® Product Benefits
Recombumin® is a multitool for advanced therapy, pharmaceutical, vaccine, diagnostics, and medical device manufacturers, offering benefits through a range of applications.
- Chemically defined culture; Consistent Performance
- Extended cell viability window; Maximize therapeutic effect
- Longer in-liquid stability; Extended shelf-life
- Adsorption prevention; Improved dose control
- Minimize aggregation; Enhanced safety profile
Recombumin® Specifications
Attribute | Specifications |
|---|---|
Manufacturing Organism | Proprietary genetically modified yeast strain |
Manufacture Quality | ICHQ7 cGMP Facility |
Format | Liquid Product |
Presentation | 50ml Vials | 1L Bioprocessing Bag (depending on Recombumin® product line) |
Stability | 5 years when stored at 2 °C - 8 °C |
Product Use | For further manufacture in advanced therapy, pharmaceutical, vaccine, medical device and diagnostic products |
Drug Master File(s) | Extensive regulatory support packages can be provided for the Recombumin® range |
Your Choice of Albumin Matters
Recombumin® a Multifunctional Excipient, Ancillary, and Raw Material
Addressing the Need for Stabilization
To ensure that patients receive the most from an advanced therapy or biopharmaceutical, it’s essential to maximize the activity and safety of the final therapeutic product. Optimizing your development and formulation strategy can help address this challenge.
The Recombumin® Solution
Recombumin® recombinant human albumin is a multifunctional excipient, and its stabilization properties have been validated across multiple products. For complex biopharmaceuticals, such as advanced therapies, Recombumin® addresses a growing need for chemically-defined, consistent, animal- and human-origin-free, and high-performance products.
The Albumedix Customer Journey
When you choose Recombumin®, you get a high-quality biopharmaceutical enabling solution along with expert support for your application and documentation. Contact us to learn more about how we can help with your specific needs and goals.
Albumedix, Now Part of Sartorius
Albumedix is a science-driven company and recognized leader of best-in-class albumin-enabled solutions. Established in the UK in 1984 with a mission to empower excellence, Albumedix has supported life-science partners across nearly four decades to deliver hundreds of millions of doses of clinical and marketed therapeutics worldwide.
Learn More About Recombumin®
FAQs | Recombumin® Recombinant Human Albumin
Recombumin® is our portfolio of recombinant human albumin products. Recombumin® recombinant human albumins provide high purity and consistency, supporting advanced therapies at every stage of their journey - from research and development to in-human application.
Please contact us to place an order or for additional product information.
Recombumin® is manufactured at a purpose-built manufacturing site in Nottingham, UK. Recombumin® recombinant human albumin is manufactured in a proprietary Saccharomyces yeast strain using ICH Q7 cGMP standards.
Recombumin® is a versatile stabilizer already in-use across multiple application areas. You can use it to address formulation challenges for peptides and proteins, vaccines, cell therapies, and medical device coating.
Yes. Recombumin® recombinant human albumin is already used in two marketed vaccine products; Merck Sharpe & Dohme Corp.’s M-M-R®-II and ProQuad® childhood vaccines. Since Recombumin® was introduced in the M-M-R®-II vaccine in 2006, more than 200 million doses have been administered to children worldwide.
Recombumin® is also used in several medical devices.
Recombinant human albumin is consistent human and animal origin free albumin protein expressed by a genetically modified host.
Recombinant human albumin is produced by expressing the relevant genes in a genetically modified host, for example, Saccharomyces Cerevisiae yeast.
Recombumin® Infographics
- Recombumin® - Batch-to-Batch Consistency PDF | 171.3 KB
- Recombumin® - Comparing Albumin Manufacturers PDF | 1.2 MB
- Recombumin® - Improving Diagnostics PDF | 2.0 MB
- Recombumin® - Medical Device Coating PDF | 841.3 KB
- Recombumin® - Vaccine Stabilization PDF | 886.7 KB
- Recombumin® - Cell Therapy Processing, Cryopreservation and Formulation PDF | 907.2 KB
