Description
Product Overview
Human Serum Albumin (HSA) — US Origin is a high-purity human plasma protein (purity ≥96–99% depending on grade, endotoxin ≤5 EU/mg) sourced from certified US plasma donors under full traceability and regulatory documentation. Available in lyophilised powder and liquid formats, from 5 g to 1 kg, with research, diagnostic, and pharma grade options.
HSA is the human-origin alternative to BSA wherever bovine-derived proteins are excluded — in human cell culture, drug formulation, IVD manufacturing, and clinical diagnostics. Explore our full HSA product page or browse the complete Human Sera & Plasma portfolio.
HSA vs. BSA — When to Use Human Serum Albumin
Bovine Serum Albumin (BSA) is the standard albumin for most research applications. HSA is required or preferred in four specific scenarios:
- Human cell culture & ATMP manufacturing — where bovine-origin proteins are excluded for regulatory or process reasons; HSA is species-matched and avoids xenogeneic protein concerns
- Biopharmaceutical formulation — HSA is a compendial excipient (Ph. Eur., USP) used to stabilise protein biologics, vaccines, and cell therapy products
- IVD & clinical diagnostics — as a calibration standard, matrix matching protein, or assay component where human-origin matrix is required
- Drug-protein binding studies — pharmacokinetic research where binding affinity to human albumin (not bovine) is the relevant variable
For a full comparison of HSA, rHSA, and BSA — including grade selection guidance — see our rHSA vs HSA vs BSA Guide.
Technical Specifications
| Parameter | Specification | Notes |
|---|---|---|
| Source | Human plasma — US origin | Certified, traceable donor plasma |
| Purity | ≥96% (Research) / ≥99% (Diagnostic/Pharma) | Electrophoresis |
| Endotoxin | ≤5 EU/mg | LAL test per lot |
| Format | Lyophilised powder or liquid | Grade-dependent |
| Available sizes | 5 g, 10 g, 25 g, 50 g, 100 g, 500 g, 1 kg | Larger volumes on request |
| Storage | 2–8 °C (liquid); RT sealed (powder) | — |
| Grades available | Research / Diagnostic / Pharma | Pharma grade on request |
HSA Grades — Research, Diagnostic & Pharma
| Grade | Purity | Endotoxin | Ideal for |
|---|---|---|---|
| Research Grade | ≥96% | ≤5 EU/mg | Cell culture supplementation, blocking, protein standard, drug-binding studies |
| Diagnostic Grade | ≥99% | ≤1 EU/mg | IVD manufacturing, calibration standards, clinical assay components |
| Pharma Grade | ≥99% | ≤0.5 EU/mg | Biopharmaceutical formulation, ATMP stabilisation, GMP excipient (on request) |
Applications
- Cell culture & serum-free media — human-origin albumin supplement for primary human cells, iPSCs, T-cell expansion, and ATMP manufacturing; avoids xenogeneic BSA in GMP processes
- Biopharmaceutical formulation — compendial excipient (Ph. Eur. 0258, USP) for stabilising monoclonal antibodies, recombinant proteins, and vaccines; prevents surface adsorption and aggregation
- IVD & clinical diagnostics — calibration standards, matrix-matching protein for serum-based assays, QC material for clinical chemistry analysers
- Drug-protein binding studies — pharmacokinetic plasma protein binding assays (PPB) where human albumin binding affinity is the relevant parameter; equilibrium dialysis, ultrafiltration, and SPR applications
- ELISA & immunoassay blocking — human-matrix blocking where bovine albumin would cross-react with anti-BSA antibodies present in patient samples
- Vaccine stabilisation — HSA as carrier/stabiliser in vaccine formulations requiring human-derived excipients
Available Formats
| Format | Size |
|---|---|
| Lyophilised Powder | 5 g |
| Lyophilised Powder | 10 g |
| Lyophilised Powder | 25 g |
| Lyophilised Powder | 50 g |
| Lyophilised Powder | 100 g |
| Lyophilised Powder | 500 g |
| Lyophilised Powder / Liquid | 1 kg |
Larger volumes and pharma grade available on request — contact us for a tailored quote and grade-specific documentation package.
Key Benefits
Batch Reservation
Reserve validated lots up to 36 months for reproducible long-term workflows.
Full Documentation
CoA, endotoxin certificate, Certificate of Origin (US), donor traceability statement — ISO 9001 and ISO 13485 certified partner facilities.
EU & Swiss Supply
Sourced from certified EU and Swiss partner facilities — fast delivery across EU, UK and Switzerland, full documentation included.
Frequently Asked Questions
What is the difference between HSA, rHSA, and BSA — and when should I use each?
BSA (bovine serum albumin) is the standard choice for most research applications: Western blot, ELISA, protein quantification, PCR stabilisation. HSA (human serum albumin, plasma-derived) is required where human-origin matrix is needed — human cell culture, IVD manufacturing, and drug-protein binding studies using the clinically relevant protein. rHSA (recombinant human serum albumin) is fully animal-origin-free and preferred for GMP ATMP manufacturing and processes where plasma-derived proteins are excluded. For a full comparison, see our rHSA vs HSA vs BSA Guide.
Is plasma-derived HSA safe to use, and what viral safety documentation is provided?
SeamlessBio HSA is sourced from US-licensed plasma collection centres operating under FDA oversight (21 CFR Part 640). Donor plasma is tested for HIV, HBV, HCV, and other relevant pathogens per FDA requirements. Manufacturing includes viral inactivation steps (e.g. pasteurisation at 60 °C for 10 hours — the established HSA viral inactivation standard). A viral safety summary and donor traceability statement are available on request alongside the CoA and Certificate of Origin.
Can HSA be used as a GMP excipient for biopharmaceutical formulation?
Yes — Human Serum Albumin is a compendial excipient listed in Ph. Eur. (monograph 0258) and USP, and is widely used to stabilise protein biologics, vaccines, and cell therapy products. For GMP use, pharma grade HSA (≥99% purity, ≤0.5 EU/mg) with full regulatory documentation is available on request. Contact our team to discuss your specific formulation grade, batch size, and documentation requirements.
Why use HSA instead of BSA for human primary cell culture or ATMP manufacturing?
BSA is xenogeneic — bovine-origin protein can trigger immune responses in human cells and introduces animal-derived components that complicate GMP documentation for ATMPs (e.g. CAR-T, NK cell therapies). HSA is species-matched to human cells and is accepted by EMA and FDA as a human-origin supplement in ATMP manufacturing. For processes requiring fully animal-origin-free conditions, rHSA is the preferred alternative.
What sizes and grades are available, and is batch reservation possible?
HSA is available in sizes from 5 g to 1 kg in research and diagnostic grade; pharma grade is available on request. Batch reservation is available for up to 36 months — contact our team with your volume, grade, and timeline. There is no fixed minimum order quantity.
Request a Quote or Sample
48h response · EU & Swiss Supply · Research, Diagnostic & Pharma Grade · Full documentation
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