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  • Recombinant Albumin

Recombinant Human Serum Albumin

Selecting the right recombinant human albumin for your application

Albumin is the most abundant protein component of mammalian blood serum and plays a multifactorial role in supporting binding and transport of ions, fatty acids, vitamins, hormones, small-molecule drugs, and toxins, as well as in regulating serum pH, osmotic pressure, and providing antioxidant activity. As such a versatile molecule for supporting cell health and growth, albumin is indispensable for various life sciences applications.

Historically, the least expensive and most abundant source of laboratory-grade albumin has been from the serum of cows (BSA or FBS/FCS). However, the sensitive applications used to investigate, develop, and manufacture advanced biologic therapies require human albumin and a greater degree of purity than can be obtained through purification from complex biological sources.

InVitria offers a suite of recombinant human albumin products, each of which is completely free of animal or human components and produced in a scalable, non-mammalian recombinant expression system. InVitria’s recombinant human albumin products are manufactured according to good manufacturing practices at an ISO9001:2015 certified facility in Kansas, USA and are naturally free of prion agents and pose a much lower risk of contamination with other human or mammalian adventitious agents compared to serum-derived components. Their purity makes them ideal for demanding research and commercial applications.

Here’s how to choose the albumin product that is right for your needs:

    • Cellastim® S rHSA is specifically optimized to enhance cell doubling times, deliver essential lipids, micronutrients, and antioxidants, while reducing oxidative stress in cell culture applications. It is of suitable purity for inclusion in serum-free and chemically defined cell culture media. Cellastim S is lipid-enhanced for excellent, consistent growth and directed differentiation of a wide variety of human cell types, including T-Lymphocytes, HEK293, hybridoma/NS0, CHO, fibroblasts, mesenchymal stem cells, hematopoietic stem cells, and virus production in VERO/MDCK cell culture.
    • Exbumin® rHSA has passed regulatory approval in the US and Europe as a final-formulation excipient for therapeutic applications. It is one of the few excipients available to improve viral stability for vaccines and gene therapies. Exbumin is also used to maintain tissue viability during cryo-preservation or storage. It also helps to stabilize cells and tissue used in cell therapy and regenerative medicine applications.
    • Optibumin® 20 rHSA is the highest-purity rHSA available on the market. With exceptionally low levels of albumin aggregates and lipids, and an exceptionally high concentration of free-thiol/Cys-34 mercapto-albumin, Optibumin is optimized for the most demanding of applications, including solubilization or bioconjugation of therapeutic entities in order to improve their pharmacokinetics, inclusion in medical devices, and support for in vitro fertilization and cord blood cryopreservation, as well as iPSC and hESC.
    • Optibumin® 25 rHSA is a high-purity, recombinant human albumin formulated at the same 25% concentration as serum-derived HSA, making it ideal for seamless integration into existing workflows. With the highest concentration of free-thiol/Cys-34 mercapto-albumin and exceptionally low levels of albumin aggregates and lipids, Optibumin 25 is optimized for closed-system biomanufacturing, cell therapy processing, and advanced pharmaceutical applications. It supports drug conjugation, pharmacokinetic modulation, tissue preservation, and cryopreservation of cells and biologics. Optibumin 25 is available in 100 mL bags, ensuring sterility and consistency for closed-system workflows in regulated biomanufacturing environments.

Recombinant Albumin

At a Glance: InVitria rHSA products
AttributeCellastim SExbuminOptibumin 20 / 25
PositioningLipid-enhanced cell culture albuminPharmaceutical excipient gradeUltra-high purity liquid (20% & 25%) and closed-system ready (25%)
FormLyophilized powderLyophilized powderSterile liquid
Protein content>96%>98%>99%
Pack sizes10g, 100g (bulk options)10g, 100g (bulk options)20%: 100 mL, 1 L bottles
25%: 100 mL sterile bags & bottles (bulk options)
Storage−20°C, 4-year shelf life−20°C, 4-year shelf life2–8°C, 2-year shelf life
ReconstitutionSterile water or PBSSterile water or PBSReady-to-use
Key applications• Serum-free media for CHO, HEK293, hybridoma
• T-cell expansion for CAR-T manufacturing
• Viral vector production in VERO/MDCK
• MSC and HSC culture for cell therapy
• Antibody production in hybridoma/NS0
• Vaccine stabilization (viral and mRNA)
• Gene therapy excipient for AAV and lentivirus
• Therapeutic protein formulation and lyophilization
• Injectable biologic stabilization replacing plasma HSA
• Cell therapy processing buffers
• Drug conjugation and pharmacokinetic modulation
• Stem cell expansion (iPSC, MSC, HSC) in defined media
• In vitro fertilization and reproductive medicine
• Cell therapy manufacturing in closed-system bioreactors
• Cryopreservation at high concentration
• Direct replacement for 25% serum-derived HSA
Performance features• Lipid-enhanced delivery of essential fatty acids
• Optimized for cell proliferation with reduced oxidative stress
• Superior viability vs standard albumin in serum-free systems
• Enhanced differentiation support for stem cells
• Regulatory precedent: used in FDA/EMA-approved ERVEBO vaccine
• Pharmaceutical-grade purity with defined sodium specification
• Maintains antigen integrity during storage
• Prevents aggregation in therapeutic formulations
• Highest purity available with minimal impurities and aggregates
• Maximized free thiol content: >0.5 mol Cys-34 per mol albumin (20%); >0.6 mol Cys-34 per mol albumin (25%)
• Ready-to-use format eliminates reconstitution variability
• Closed-system compatibility prevents contamination (25% bag format)
• Process integration matches serum-derived HSA concentration (25%)
Learn MoreCellastim SExbuminOptibumin 20
Optibumin 25

Applications by Industry

Cell Culture & Biomanufacturing

InVitria rHSA products support serum-free and chemically defined media formulations for mammalian cell culture, including CHO, HEK293, and hybridoma cell lines. The animal-origin-free profile eliminates regulatory concerns while providing consistent performance.

Cell Therapy & Regenerative Medicine

Optibumin products are specifically designed for cell therapy processing buffers, stem cell expansion, and cryopreservation applications where regulatory compliance and lot-to-lot consistency are critical.

Drug Formulation & Stabilization

Exbumin is the only FDA and EMA-approved recombinant albumin excipient, providing superior protein and viral stabilization for vaccine formulations and gene therapy applications.

 

rHSA vs. Plasma-Derived HSA vs. BSA: Technical Comparison

Specification InVitria rHSA Plasma-Derived HSA BSA
Source Recombinant expression Human plasma donors Bovine serum
Animal/Human Components None (animal-origin-free) Human-derived Animal-derived
BSE Risk None None Potential risk
Lot-to-Lot Variability Minimal (controlled expression) High (donor variability) High (batch variability)
Viral Safety No viral risk  Potential risk  Potential risk
GMP Suitability Designed for GMP Available Research grade typical

 

Regulatory Documentation

  • Certificate of Analysis with batch-specific data
  • Animal-origin-free certification
  • TSE/BSE compliance statement
  • Regulatory support documentation for submissions
  • ISO 9001:2015 manufacturing certification

Recombinant Human Albumin FAQ

Product Selection & Comparison

What is recombinant human serum albumin (rHSA)?

Recombinant human serum albumin is produced using recombinant DNA technology in non-animal expression systems, providing the identical amino acid sequence as native human albumin while eliminating animal-derived contamination risks.

Can recombinant albumin replace BSA in cell culture?

Yes, rHSA can directly replace BSA in cell culture applications. rHSA provides human-sequence compatibility, eliminates BSE contamination risk, offers superior lot-to-lot consistency, and is suitable for GMP manufacturing environments.

Which InVitria rHSA product should I choose?

Product selection depends on your application: Cellastim S for lipid-enhanced cell culture, Exbumin for FDA/EMA-approved formulations, Optibumin 20/25 for highest-purity applications requiring minimal aggregates and optimal free-thiol content.

Technical Specifications

What makes InVitria rHSA superior to plasma-derived HSA?

InVitria rHSA eliminates donor-to-donor variability, provides consistent lot-to-lot performance, removes viral contamination risk, and offers animal-origin-free certification for regulatory compliance.

Is rHSA suitable for GMP manufacturing?

Yes, all InVitria rHSA products are manufactured under ISO 9001:2015-certified, cGMP-compliant conditions with comprehensive documentation packages supporting regulatory submissions.

Related Resources

Resource Type Title Cell Lines Relevance
Application Note Preserving Lentiviral Titer During Sterile Filtration Using Recombinant Albumin T Lymphocyte Excipient-grade rHSA preserves lentiviral titer through sterile filtration.
Application Note High-Resolution Analytical Characterization of Optibumin®: Structural Homogeneity and Functional Consistency Compared to Plasma-Derived HAS — High-resolution analytical comparison of recombinant vs plasma-derived HSA.
Application Note Recombinant Albumin as a Carrier Protein Improves Cytokine Recovery and Functional Stability at Dilute Concentrations — Cytokine carrier function: improves recovery of dilute formulations and unlocks room-temperature stability.
Application Note A Binding Advantage: Optibumin® Demonstrates Enhanced Drug Binding and Consistency over Plasma Albumin — Drug-binding affinity, aggregate burden, and Cys34 redox state vs plasma HSA.
Application Note Cellastim S – Reconstitution Application Note Mesenchymal Stem Cells, Hematopoetic Stem Cells, T Lymphocyte, HEK293, VERO Cellastim S liquid stock preparation for cell culture applications.
Application Note rHSA Reconstitution Video Protocol — Video walkthrough of rHSA reconstitution.
Application Note Thiol by Combat: Enhanced Covalent Conjugation with Recombinant Albumin Compared to Human Plasma-Derived Albumin — Cys34 redox state and covalent conjugation performance vs plasma HSA.
Application Note Superior Cryopreservation of T Cells in Low-DMSO, Animal-Origin-Free Formulation Using Optibumin® 25 and PentaHibe® Base T Lymphocyte T-cell cryopreservation: matches CS10 at significantly reduced DMSO concentrations.
Application Note Improved iPSC Cryopreservation with Optibumin® 25: Enhanced Viability, Expansion, and Pluripotency iPSC iPSC cryopreservation with reduced DMSO and maintained pluripotency.
Application Note Low-DMSO Cryopreservation of MSCs with Optibumin® 25 Recombinant Albumin Mesenchymal Stem Cells Low-DMSO MSC cryopreservation with recombinant albumin.
Application Note Retain and Protect Final Cell Product with Optibumin®, a Recombinant Human Serum Albumin (rHSA) T Lymphocyte T-cell wash buffer performance vs clinical HSA.
Application Note Enhanced Cryopreservation of T Cells Using Optibumin®, Recombinant Human Serum Albumin (rHSA) T Lymphocyte T-cell cryopreservation performance with rHSA.
Application Note T Cell Cryopreservation Using Exbumin®, Recombinant Human Serum Albumin, and Reduced DMSO T Lymphocyte Exbumin in T-cell cryopreservation: reduced DMSO and improved viability.
Application Note Maintaining Viable Cell Count in Primary T Cells During Cell Washing Using Optibumin® T Lymphocyte T-cell wash buffer performance with rHSA.
Application Note DMSO-Free Cryopreservation of Human T Lymphocytes in Chemically Defined Systems T Lymphocyte DMSO-free T-cell cryopreservation with rHSA.
Application Note DMSO-Free Cryopreservation of Mesenchymal Stem Cells in Chemically Defined Systems Mesenchymal Stem Cells DMSO-free MSC cryopreservation with rHSA.
Application Note Exbumin – Reconstitution Application Note — Exbumin reconstitution protocol for excipient applications.
Application Note Exbumin – Stabilizing Virus with Albumin to Improve Yield Application Note HEK293, VERO Excipient-grade rHSA stabilizes viruses across multiple production cell lines.
White Paper High-Quality Recombinant Human Serum Albumin (rHSA), Exbumin™, for Improved Cell Wash Buffer Preparation — Excipient-grade rHSA in cell wash buffer preparation.
White Paper Optimizing the Performance of LNP and Liposome Therapeutics with Blood-Free Recombinant Albumin — rHSA in LNP and liposome therapeutic formulations.
White Paper Emergence of Blood-Free Recombinant Human Albumin — Foundational platform overview of rHSA across biomanufacturing applications.
White Paper Cellastim S – Recombinant Human Serum Albumin in the Generation of Functional Cardiomyocytes from Pluripotent Stem Cells iPSC, ESC rHSA in pluripotent stem cell differentiation to cardiomyocytes.
Poster Enhancing Cell Therapy Consistency and Safety: Recombinant Human Albumin as a Defined Alternative to Plasma-Derived Albumin in Wash and Cryopreservation Workflows T Lymphocyte, Mesenchymal Stem Cells Structural homogeneity and functional validation in T-cell and MSC workflows.
Poster Stronger Cells for Safer Therapies: Low-DMSO, Animal-Origin-Free T Cell Cryopreservation with Optibumin 25 and PentaHibe T Lymphocyte Low-DMSO T-cell cryopreservation with rHSA poster.
Poster Better Cells, Better Outcomes: Improving CAR-T Manufacturing with Animal-Free Cryopreservation and Wash Solutions T Lymphocyte CAR-T-specific wash and cryopreservation data.
Poster Advancing Vaccine Excellence VERO Recombinant albumin in vaccine cold-chain stability and excipient applications.
Poster Addressing Vaccine Stability And Cold Chain Challenges With Recombinant Human Serum Albumin To Enable Global Administration — Vaccine cold-chain stabilization across multiple virus types.
Poster Cryoprotectant Additives, Including rHSA, Improve iNK and iT Cell Health & Viability During Cryopreservation T Lymphocyte, Natural Killer Cells, iPSC Excipient-grade rHSA improves iNK and iT cell cryopreservation outcomes.
Poster Virus Yield Improvement for Downstream Processing: Exbumin®, Excipient Recombinant Albumin — Excipient rHSA in viral downstream processing and final formulation.
Poster DMSO-Free Cryopreservation Formulation As An Alternative Cryopreservation Method For Cell-based Therapies — DMSO-free cryopreservation alternative with rHSA.
Poster Cellastim S – Optimizing Antibody Production in Animal-Free Media with the Supplementation of Recombinant Human Albumin CHO, Hybridoma rHSA performance in CHO mAb production: IVCN, titer, long-term passaging.
Case Study How Merck Used Recombinant Albumin in ERVEBO to Establish a Novel Excipient Pathway — First FDA-approved novel excipient pathway for rice-derived rHSA in human vaccines.
Journal Articles (DOI Links) Rapid Quantitation of SARS-CoV-2 Antibodies Using an Electrochemical Sensor — Diagnostic application: rHSA reduces non-specific binding in electrochemical antibody sensors.
Journal Articles (DOI Links) Utilization of Recombinant Albumins in the Expansion of Human T Lymphocytes T Lymphocyte Peer-reviewed publication on rHSA in T-cell expansion.
Journal Articles (DOI Links) Accurate nanoelectrode recording of human pluripotent cell-derived cardiomyocytes for assaying drugs and modeling disease iPSC, ESC rHSA in pluripotent stem cell-derived cardiomyocyte applications.
Webinar GEN Webinar: Why Cell Quality Erodes During Downstream Processing — and How to Prevent It — How rHSA mitigates shear and oxidative damage in downstream processing.
Webinar Accelerating Vaccine Development Through Use of Blood-Free Components — Webinar on rHSA in vaccine development.
Infographic Optimizing CAR-T Manufacturing with Defined, AOF Components T Lymphocyte Visual guide to rHSA across CAR-T manufacturing.
Blog Beyond Synthetic Surfactants: The Case for Recombinant Human Serum Albumin (rHSA) as an Ideal Alternative to Poloxamer 188 CHO, T Lymphocyte Mechanistic comparison: shear protection, antioxidant capacity, and metal sequestration vs P188.
Blog Replacing the “Necessary Evil”: Recombinant Human Serum Albumin as a Chemically Stable Alternative to Polysorbates in Biopharmaceutical Formulation — Stability comparison: polysorbate degradation vs rHSA in biologics formulations.
Blog The “Cheap” Albumin Paradox: The Actuarial Cost of Serum Albumin in Biomanufacturing CHO, T Lymphocyte Actuarial cost analysis: viral risk, variability, testing burden, regulatory delay, supply fragility.
Blog Supply Chain Resilience: The Fragility and Finite Nature of Serum-Derived Raw Materials — FBS, plasma, and donor supply fragility — strategic case for recombinant alternatives.
Blog Safety and Contamination Risks: The Testing Burden and Persistent Threats — BVDV, TSE/BSE, CJD/vCJD: the safety case for recombinant alternatives.
Blog Variability and Failed Lots: The Hidden Quality Control Challenge of Serum & Serum-Derived Products — Protein heterogeneity, oxidation state, bound ligand variation — recombinant alternative case.
Blog Consistency Is the New Compliance — Regulatory shift toward defined materials and the implications for albumin sourcing.
Blog Albumin in Drug Delivery: Cancer’s Unexpected Achilles’ Heel — Albumin in oncology drug delivery: Abraxane, GLP-1, siRNA conjugate examples.
Blog Cryopreservation Just Got Better with Optibumin® 25 T Lymphocyte Optibumin 25 in T-cell cryopreservation: expansion, DMSO reduction, memory phenotype.
Blog How Regulatory Bodies Are Driving the Shift to Animal-Origin-Free Solutions in Cell Therapy and Vaccine Development — Why FDA, EMA, WHO and PMDA are driving the shift away from blood-derived albumin.
Blog Innovative Solutions in Closed-System Biomanufacturing: Exploring the Tools and Technologies Driving Sterility and Efficiency — How closed-system biomanufacturing tools integrate with rHSA supplementation.
Blog Evolving Challenges in Closed-System Biomanufacturing — Closed-system manufacturing challenges and the role of recombinant raw materials.
Blog Optibumin vs Traditional Albumin: Comparing Performance in Cell Wash Applications T Lymphocyte Recombinant vs plasma HSA in cell wash applications.
Blog Scaling Innovation: How DiscGenics and InVitria are Leading the Future of Cell Therapy Mesenchymal Stem Cells Customer story: scaling allogeneic cell therapy manufacturing with rHSA.
News InVitria Launches Optibumin 25 rHSA — Launch of the first 25% recombinant HSA solution.

InVitria rHSA Products

  • Cellastim® S – Recombinant human albumin
  • Exbumin® – Recombinant human albumin excipient
  • Optibumin® 20 – Recombinant human albumin
  • Optibumin® 25 – Recombinant human albumin

The only rHSA excipient approved by FDA and EMA

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