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.

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Discover the mechanisms of action that define Recombumin® recombinant human albumin as a must-have multitool for advanced therapy biopharma, medical device, and diagnostic developers.

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 Benefits Through a Balance of Biological, Chemical, and Physical Properties

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

Adsorption: Non-specific adsorption without Recombumin® vs. Recombumin® preventing non-specific adsorption.
  • Readily adsorbs to hydrophobic and hydrophilic surfaces
  • Forms a single monolayer
  • Prevents nonspecific adsorption

Recombumin® Prevents Aggregation

Aggregation: Aggregation without Recombumin® vs. Recombumin® preventing aggregation
  • Prevents aggregation
  • Disperses uniformly in a solution
  • Minimizes physical drug instability

Recombumin® Prevents Oxidation

Oxidation: Free radicals without Recombumin® vs. Recombumin® protecting against free radicals
  • Scavenges free radicals
  • Protects formulations against modification from oxidation stress
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Recombumin® Acts as a Transporter

  • Forms complexes with metals and molecular entities

  • Transporting these into and out of the cell

Recombumin® Carries Nutrients

  • Binds and transports nutrients

  • Albumin is itself a rich nutrient source for cell

Recombumin® buffers pH

  • Binds to hydrogen ions and buffers pH
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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

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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

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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.

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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.

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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.

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Learn More About Recombumin®

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Optimise your upstream and downstream processes today. Beyond Evolution. Recombumin® - Albumin Revolution by Design.

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Albumedix Scientific Library

Find scientific papers, infographics, and application notes authored and co-authored by some of our leading scientists, collaborators, and partners.

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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 visit our eShop or  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.

Datasheet

Recombumin® - Recombinant Human Albumin

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Recombumin® Downloads

Infographic

Recombumin® Recombinant Human Albumin

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Infographic

Recombumin® Recombinant Human Albumin | Medical Device Applications

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Cell and Gene Therapy

Learn more about Sartorius' contribution.

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Regenerative Medicine

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Viral Vectors

Gene-Modified Cell Therapy

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