Description
Product Overview
SeamlessBio Human Serum Albumin 20% is a sterile, high-concentration HSA solution for use as an excipient and ancillary material in cell therapy manufacturing and biological product formulation. The 20% concentration is the international industry standard for HSA in cryopreservation, ATMP final formulation, and stabilisation of biological active substances. Manufactured under ISO 13485-certified conditions with full TSE/BSE freedom declaration and complete donor-to-batch traceability from EU-certified donor centres. Available in glass vials and single-use bags — no minimum order quantity, direct EU supply.
Technical Specifications
| Parameter | Specification |
|---|---|
| Concentration | 20% (200 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 |
|---|---|
| Cryopreservation of cell therapy products | Standard additive in freezing media for CAR-T cells, NK cells, MSCs, and HSC. Typical final concentration: 1–5% HSA from a 20% stock, combined with 10% DMSO in serum-free base medium. SeamlessBio supplies both HSA and DMSO from a single source with matched documentation. |
| ATMP final formulation | As an excipient in final product formulation, HSA 20% stabilises the cell suspension prior to filling — protecting against aggregation, oxidation, and adsorption to infusion system surfaces. |
| Process medium & supplement | Concentrated supplement in serum-free and xeno-free cell culture media. Typical final concentration: 0.5–2% HSA. |
| Stabilisation of biological active substances | Protection of antibodies, viral vectors (AAV, lentivirus), and growth factors against degradation through surface adsorption and oxidative stress during storage and freeze-thaw cycles. |
Packaging Options
| Format | Advantage | Typical Use |
|---|---|---|
| Glass vial 10 mL, 50 mL, 100 mL, 250 mL, 500 mL |
Chemical inertness, lab standard, easy handling | R&D, small process batches, formulation development |
| Single-use bag 250 mL, 500 mL, 1 L, 2 L, 5 L (on request) |
Closed system, scalable, GMP-compatible | GMP-adjacent processes, clinical manufacturing, ATMP Phase I/II |
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, 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 (this product) | 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 cryopreservation and ATMP formulation 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 HSA 20% concentration in cell therapy cryopreservation media?
The standard final HSA concentration in cryopreservation media for cell therapy products (CAR-T, NK cells, MSCs, HSCs) is 1–5% v/v — prepared from a 20% stock solution. The most widely used protocol combines 10% DMSO final with 2–5% HSA final in serum-free base medium (PBS or PlasmaLyte A). SeamlessBio supplies both components — HSA 20% and DMSO ≥99.9% — from a single source with matched CoA and SDS documentation, simplifying supplier qualification and GMP-adjacent batch record management.
What formats and volumes is HSA 20% available in?
HSA 20% is available in glass vials (10 mL, 50 mL, 100 mL, 250 mL, 500 mL) and single-use bags (250 mL, 500 mL, 1 L, 2 L, 5 L — on request). Custom fill volumes are possible for both formats. Glass vials are the standard for R&D and process development; single-use bags provide a closed system for GMP-adjacent and clinical manufacturing workflows. Contact us with your required volume and format for availability and lead time.
What is the difference between HSA 20% and HSA 25%?
HSA 20% (200 g/L) is the international standard for cryopreservation and ATMP formulation and is the more widely used concentration across validated clinical protocols. HSA 25% (250 g/L) offers a 25% higher protein concentration, which becomes relevant when total formulation volume is strictly constrained — for example in final drug product fill steps with tight volume specifications. For most cryopreservation applications and process development work, HSA 20% is the recommended starting point. Both concentrations are available from SeamlessBio.
Is HSA 20% suitable for GMP cell therapy manufacturing?
SeamlessBio HSA 20% is manufactured under ISO 13485-certified conditions and is suitable for R&D and GMP-adjacent Phase I/II manufacturing as an ancillary material or excipient. For commercial GMP manufacturing with EP/USP pharmacopoeial requirements, the regulatory framework depends on your specific process and product classification — contact our team to assess the appropriate grade for your regulatory strategy and development phase.
What documentation is included with HSA 20%?
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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