Description
Product Overview
SeamlessBio Human Serum Albumin 5% is an isotonic, sterile HSA solution for use as an ancillary material in cell therapy development and manufacturing. The 5% concentration matches physiological plasma albumin levels and is the preferred choice for cell washing, density gradient separation, and transfer buffer steps where an isotonic protein matrix is required without high protein load. Manufactured under ISO 13485-certified conditions with full TSE/BSE freedom declaration and complete EU donor-to-batch traceability. Available in glass vials and single-use bags — no minimum order quantity.
Technical Specifications
| Parameter | Specification |
|---|---|
| Concentration | 5% (50 g/L) |
| Form | Sterile solution |
| Purity | ≥96% albumin |
| pH | 6.7–7.3 |
| Endotoxin | ≤5 EU/mL (LAL method) |
| Sterility | 0.2 µm sterile filtered |
| Origin | EU — certified donor centres |
| TSE/BSE | Freedom declaration included |
| Quality standard | ISO 13485 |
| Packaging | Glass vial or single-use bag |
| Documentation | CoA, CoO, SDS, TSE/BSE statement |
Applications
| Application | Description |
|---|---|
| Cell washing & separation | Standard buffer additive for washing T cells, NK cells, and HSC after activation, transduction, or selection steps. Typical working concentration: 0.5–1% HSA final in PBS or PlasmaLyte A. |
| Density gradient separation | Protein additive in the dilution step prior to Ficoll/Lymphoprep centrifugation during PBMC isolation and leukopak processing — reduces non-specific cell loss and maintains viability. |
| Process formulation & transfer buffers | Isotonic base solution for intermediate cell transfer suspensions and process buffers in ATMP manufacturing — prevents non-specific adhesion to surfaces and reduces mechanical cell stress. |
| Post-thaw DMSO dilution | Carrier protein in the post-thaw dilution step to reduce DMSO concentration rapidly while stabilising cell viability during recovery from cryopreservation. |
Packaging Options
| Format | Advantage | Typical Use |
|---|---|---|
| Glass vial 10 mL, 50 mL, 100 mL, 250 mL, 500 mL |
Chemical inertness, established standard, easy storage | R&D, small batches, process development |
| Single-use bag 250 mL, 500 mL, 1 L, 2 L (on request) |
Closed system, no contamination risk, GMP-compatible | GMP-adjacent processes, scale-up, cell therapy manufacturing |
Available Formats
| Format | Volume |
|---|---|
| Glass vial | 10 mL, 50 mL, 100 mL, 250 mL, 500 mL |
| Single-use bag | 250 mL, 500 mL, 1 L, 2 L (on request) |
HSA Concentration Comparison
| Product | Concentration | Typical Application |
|---|---|---|
| HSA 5% Solution (this product) | 50 g/L | Cell washing, separation, transfer buffer |
| HSA 20% Solution | 200 g/L | Cryopreservation, ATMP final formulation |
| HSA 25% Solution | 250 g/L | ATMP final formulation at minimum volume, AAV stabilisation |
Key Benefits
Batch Reservation
Reserve validated lots up to 36 months for reproducible long-term cell therapy process development and manufacturing workflows.
Full Documentation
CoA, CoO and SDS — from ISO 9001 and ISO 13485 certified partner facilities. Additional documents on request.
EU & Swiss Supply
Sourced from certified EU partner facilities — fast delivery across EU, UK and Switzerland.
Frequently Asked Questions
What is the standard working concentration of HSA 5% in cell washing buffers?
In cell therapy manufacturing, HSA 5% is typically used to prepare a 0.5–1% HSA final concentration in PBS or PlasmaLyte A for T cell, NK cell, and HSC washing steps. When using HSA 5% stock directly as the base buffer, it can be used undiluted for short-term cell transfer or diluted to the required working concentration. The 5% concentration matches physiological plasma albumin levels, making it inherently isotonic and gentle for sensitive cell populations during processing steps.
What is the difference between HSA 5% in a glass vial versus a single-use bag?
Glass vials are the standard format for laboratory and process development workflows — chemically inert, easy to handle, and available in volumes from 10 mL to 500 mL. Single-use bags provide a fully closed system with no opening steps during use, which is essential for GMP-adjacent and clinical manufacturing where contamination risk must be minimised. Both formats are filled with the same product and carry identical documentation. The appropriate format depends on your process design and regulatory requirements. Custom fill volumes are available for both.
Can HSA 5% be used in the post-thaw dilution step after cryopreservation?
Yes — HSA 5% is well-suited for the post-thaw dilution step to reduce DMSO concentration in cryopreserved cell therapy products. The isotonic albumin solution stabilises cells during the critical phase of DMSO removal, reducing osmotic stress and membrane damage. A stepwise dilution protocol using HSA 5% (or DMSO-free base medium containing HSA) is standard practice in CAR-T and HSC product thawing. SeamlessBio can supply HSA 5% together with DMSO ≥99.9% and HSA 20% for complete cryopreservation process coverage from a single source.
Is HSA 5% suitable for use in GMP cell therapy processes?
SeamlessBio HSA 5% is manufactured under ISO 13485-certified conditions and is suitable for use as an ancillary material in R&D and GMP-adjacent Phase I/II cell therapy processes. Full batch documentation is provided including CoA, CoO, SDS, and TSE/BSE freedom declaration. For commercial GMP manufacturing requiring EP/USP pharmacopoeial compliance, contact our team to assess the appropriate grade for your regulatory strategy.
What documentation is supplied with HSA 5%, and what is available on request?
Every order includes a lot-specific Certificate of Analysis (CoA) covering albumin purity, pH, endotoxin, and sterility. Additional documentation available on request: Certificate of Origin (CoO), Safety Data Sheet (SDS), TSE/BSE freedom declaration, GMO statement, and donor documentation / traceability report. All documents are batch-specific and issued from ISO 13485-certified partner facilities.
Request a Quote or Sample
48h response · EU & Swiss Supply · Batch reservation available · Full documentation
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