Recombumin® Recombinant Human Albumin
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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Learn how high-quality raw materials simplify the journey of cardiomyocyte therapies from lab to clinical trials.
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.
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.
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.
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.
Forms complexes with metals and molecular entities
Transporting these into and out of the cell
Binds and transports nutrients
Albumin is itself a rich nutrient source for cell
Sartorius Albumedix technical experts can help increase your likelihood of technical and commercial success.
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Get in touch and evaluate a sample of Recombumin® in your process.
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Recombumin® is a multitool for advanced therapy, pharmaceutical, vaccine, diagnostics, and medical device manufacturers, offering benefits through a range of applications.
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Explore the variety of applications that Recombumin® recombinant human albumins can support.
In cell therapy, the source and quality of albumin has proven important for both performance and regulatory purposes. Recombumin® recombinant human albumin products are used in a range of cell therapy media and products offering high performance, consistency and extensive regulatory documentation.
Gene therapies demand stability and utilise albumin to support multiple unit operations across the workflow. Recombumin® offers a high performing, consistent and regulatory supported alternate to serum albumins.
Prophylactic to therapeutic, traditional formulations to viral vector based and oncolytic, vaccines encompass a diverse range of products. Having been safely administered as part of a final vaccine formulation over 210 million times Recombumin® has proven its value to developers and producers by protecting from sheer stress, surface adsorption, and by providing thermal stability to sensitive vaccines.
Optimizing efficiency and performance of protein and peptides can be challenging. Recombumin® has a long history in the stabilization of proteins and peptides by preventing aggregation, surface adsorption and oxidation.
The biocompatibility of coatings is crucial when developing next generation medical devices to avoid to the risk of toxicity and immunological responses leading to device rejection. The natural properties of recombinant human albumins make them a fully biocompatible choice for medical device coatings. Recombumin® supports developers by offering a recombinant, human and animal origin free batch to batch consistent albumin raw material for medical device applications.
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
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.
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.
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 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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Optimise your upstream and downstream processes today. Beyond Evolution. Recombumin® - Albumin Revolution by Design.
Find scientific papers, infographics, and application notes authored and co-authored by some of our leading scientists, collaborators, and partners.
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.
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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.
Improve the stability and post-thaw viability of your cell therapy products.
Learn how you can enhance the stability of cell therapy products with innovative biopreservation solutions.
Learn more about Sartorius' contribution.
Learn more about our single-use technologies and associated services to address the process development and production of viral vectors.
Sartorius offers comprehensive workflow packages for cell and gene therapy research and manufacturing.
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