Description
Product Overview
SeamlessBio Human Serum Albumin 25% is the highest-concentration HSA liquid formulation available, providing maximum cell protection and stabilisation at minimum added volume. Manufactured under ISO 13485-certified conditions with full TSE/BSE freedom declaration and complete donor-to-batch traceability from EU-certified donor centres. Supplied as a direct alternative to branded HSA 25% for research, process development, and GMP-adjacent Phase I/II manufacturing — with no minimum order quantity and no sales intermediary.
Technical Specifications
| Parameter | Specification |
|---|---|
| Concentration | 25% (250 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 |
|---|---|
| ATMP final formulation — tight volume limits | In the final formulation of CAR-T cells, NK cells, and other ATMPs with defined infusion volume specifications, HSA 25% delivers maximum protein protection at minimum volume contribution — a 1% final HSA from a 25% stock requires only 40% of the volume of a 20% solution. |
| Cryopreservation — high-concentration protocols | For cryopreservation protocols requiring maximum albumin-to-DMSO ratio, HSA 25% allows reaching the target final HSA concentration with a lower total volume addition to the freezing medium. |
| Viral vector stabilisation (AAV, lentivirus) | High-concentration HSA effectively protects viral vectors against aggregation and activity loss during storage and freeze-thaw cycles. Recommended as a standard stabiliser in AAV-based gene therapy product formulation. |
| Direct branded HSA 25% alternative | SeamlessBio HSA 25% is designed as a direct replacement for branded HSA 25% for R&D and GMP-adjacent Phase I/II processes — shorter lead times, no minimum order quantities, direct point of contact. |
Packaging Options
| Format | Advantage | Typical Use |
|---|---|---|
| Glass vial | Chemical inertness, lab standard | R&D, process development |
| Single-use bag | Closed system, GMP-compatible | Clinical manufacturing, scale-up |
Available Formats
| Format | Volume |
|---|---|
| Glass vial | 100 mL, 250 mL, 500 mL, 1000 mL |
| Single-use bag | 250 mL, 500 mL, 1 L, 2 L, 5 L (on request) |
HSA Concentration Comparison
| Product | Concentration | Typical Application |
|---|---|---|
| HSA 5% Solution | 50 g/L | Cell washing, separation, transfer buffer |
| HSA 20% Solution | 200 g/L | Cryopreservation, ATMP final formulation |
| HSA 25% Solution (this product) | 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 ATMP formulation and process development 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 advantage of HSA 25% over HSA 20% in ATMP formulation?
HSA 25% provides a higher protein concentration in the same volume, which is critical when total formulation volume is tightly constrained — as in many CAR-T and NK cell ATMP drug products with defined infusion volumes. Using HSA 25% instead of 20% reduces the volume of albumin solution added to the formulation by 20%, allowing more precise control of the final product volume while maintaining the same level of cell protection. For most standard cryopreservation and cell culture applications, HSA 20% is sufficient; HSA 25% is specifically relevant for final formulation steps with strict volume specifications.
Is SeamlessBio HSA 25% a direct replacement for branded HSA 25%?
For research, process development, and GMP-adjacent Phase I/II applications, yes. SeamlessBio HSA 25% is manufactured under ISO 13485-certified conditions with full TSE/BSE freedom declaration and EU-origin donor traceability — matching the key quality parameters of branded HSA 25% for R&D and early-phase clinical use. The main practical advantage is availability: no minimum order quantity, no sales pipeline, direct delivery from EU stock. For commercial GMP manufacturing requiring EP/USP pharmacopoeial compliance, please contact our team to assess the regulatory pathway together.
Can HSA 25% be used in cryopreservation medium together with DMSO?
Yes — HSA 25% can be used as the albumin component in cryopreservation media for cell therapy products. The standard protocol combines 10% DMSO with 1–5% HSA final concentration. Using HSA 25% stock instead of HSA 20% allows achieving the same final HSA concentration with a proportionally smaller volume of albumin solution added — an advantage when total freezing medium volume is constrained. SeamlessBio supplies both DMSO ≥99.9% and HSA solutions from a single source with matched documentation for simplified GMP-adjacent batch records.
What container formats is HSA 25% available in, and what volumes can be ordered?
HSA 25% is available in DMSO-resistant glass vials (standard sizes: 100 mL, 250 mL, 500 mL, 1000 mL) and single-use bags (250 mL, 500 mL, 1 L, 2 L, 5 L — on request). Custom fill volumes are available for both formats. Contact us with your required volume and format and we will confirm availability and lead time. Standard delivery from EU stock in 2–5 business days within Germany, 3–7 business days EU-wide.
What documentation is supplied with HSA 25%, and what is available on request?
Every order includes a lot-specific Certificate of Analysis (CoA) covering 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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