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, Optimised with Recombumin®
After almost forty years advancing albumin science, we continue to reveal the breadth of its biological potential. Its unique architecture enables broad ligand binding and transport, antioxidant defence via a reactive thiol, metal‑ion chelation and detoxification, and surface protection that limits aggregation and non‑specific adsorption—in vivo and throughout bioprocessing. Click the image below to uncover some of the key properties of albumin.
From Evolution to Precision: Recombumin® Albumin by Design.
Through evolution, nature has shaped albumin into a multifunctional molecule whose unique properties have supported biopharma for decades. Yet human serum albumin (HSA) from pooled plasma can carry in‑vivo‑acquired heterogeneity—truncation, glycation, oxidation, aggregation—and variable residual ligand loads from its transport role. Built on decades of innovation, Recombumin® provides animal-origin free recombinant human albumin with high purity, batch‑to‑batch consistency, and a controlled ligand profile, overcoming the variability associated with serum‑derived HSA. Harness the potential of high‑quality recombinant albumin—translated into optimised, consistent performance across formulations and processes where it matters most.
Functional Benefits
Balanced biological, chemical and physical properties for robust performance
Manufacturing, formulation, storage and dosing expose advanced therapies to various stresses (e.g., shear, freeze–thaw, interfacial contacts, pH and ionic shifts) that drive aggregation, adsorption and degradation. Recombumin®-a chemically defined recombinant human albumin—serves as a formulation and process stabiliser for proteins, peptides, vaccines, and cell and gene therapies. As a supplement to cell culture media, its defined nature helps optimise media composition and reduce batch‑to‑batch variability, supporting robust growth and consistent performance. It helps minimise aggregation and particulate formation, limits interfacial and surface adsorption, and reduces chemical/oxidative degradation; in cell applications, it enhances viability under process stress.
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
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
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.
Explore Our Range of Albumin Based Solutions
Sartorius Albumedix technical experts can help increase your likelihood of technical and commercial success.
Get in touch and evaluate a sample of Recombumin® in your process.
Discover our proprietary drug delivery technology platform, Veltis®
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® Applications
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.
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
Established in the UK in 1984, Albumedix, now a part of Sartorius, has supported its life science partners to deliver hundreds of millions of doses of clinical and marketed therapeutics, globally. The Recombumin® portfolio of recombinant human albumins includes the world’s only USP-NF compliant recombinant human albumin.
Recombumin® recombinant human albumin products are produced in a proprietary yeast strain (Saccharomyces cerevisiae) to ICHQ7 cGMP standards, formulated in the United Kingdom, and distributed worldwide to support our customers.
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 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.
