Description
Product Overview
SeamlessBio rHSA Premium Grade is a high-purity, animal-free recombinant human serum albumin expressed in genetically modified rice endosperm (Oryza sativa). A three-step chromatography purification process delivers ≥99% purity and ultra-low endotoxin <0.125 EU/mg — meeting the most demanding quality requirements of serum-free cell culture, ATMP manufacturing, IVD reagent production, and biopharmaceutical formulation.
Structurally identical to native human serum albumin. Free of all blood-derived contaminants, TSE/BSE agents, and human or animal raw materials. Available as lyophilised powder from EU stock. For cost-sensitive IVD and cosmetic applications, see the rHSA Economy Grade. Explore the full Human Sera & Albumin Portfolio.
Technical Specifications
| Parameter | Specification |
|---|---|
| Expression system | Rice (Oryza sativa) endosperm — 100% animal-free |
| Purity (SDS-PAGE) | ≥99.0% — 3-step chromatography (HYC002M01) |
| Protein content | ≥90.0% |
| Bacterial endotoxins | <0.125 EU/mg (LAL method) |
| Dimer + polymer (non-reducing SDS-PAGE) | Specification >2.0%; typical ≤5.6% |
| pH | 6.0–8.0 |
| Appearance | Light yellow crystalline powder |
| Form | Lyophilised powder |
| Reconstitution | Sterile PBS or 0.9% NaCl; fully soluble within 15 min |
| Storage | 2–8 °C; shelf life 5 years from manufacture |
| TSE/BSE status | TSE/BSE-free — no animal raw materials used |
| Manufacturer | Wuhan Healthgen Biotechnology Corp. (Oryzogen); distributed under SeamlessBio label |
| Regulatory | For Research Use Only (RUO). CoA, CoO and SDS on request. |
Applications
| Application | Function of rHSA Premium Grade |
|---|---|
| Serum-free & xeno-free cell culture | Lipid and hormone carrier; protects CHO, HEK293, hybridoma, and Vero cells from oxidative stress and shear damage in defined media — replaces plasma-derived HSA with full lot traceability. |
| ATMP & cell therapy (CAR-T, NK, MSC) | Xeno-free supplement meeting GMP-compatible purity and endotoxin requirements for clinical cell therapy manufacturing and lentiviral/AAV vector production. |
| IVD reagent manufacturing | Ultra-low endotoxin blocking agent and stabiliser in ELISA kits, lateral flow assays, and immunoassay reagents — minimises background interference in sensitive diagnostic formats. |
| Biopharmaceutical formulation | Stabiliser for therapeutic proteins, vaccines, viral vectors, and antibody-drug conjugates in formulation buffers and drug product development. |
| Cryopreservation | Animal-free replacement for plasma-derived HSA in GMP-compatible freeze media for cells, tissues, and biological materials. |
| Cosmetics & dermatology | High-purity, animal-free protein ingredient for premium skin care, wound healing, and dermatological formulations. |
Complete SeamlessBio rHSA Portfolio
| Grade | Purity | Endotoxin | Best For |
|---|---|---|---|
| rHSA Premium Grade (this product) | ≥99% | <0.125 EU/mg | Cell culture, ATMP, IVD |
| rHSA Economy Grade | 90–99% | <5 EU/mg | IVD blocking, cosmetics, method dev |
| rHSA CHO-Expressed | ≥95% | <1 EU/mg | ADME, drug formulation |
Available Formats
| Format | Size |
|---|---|
| Lyophilised powder | 10 g |
| Lyophilised powder | 100 g |
| Lyophilised powder | 500 g |
Key Benefits
Batch Reservation
Reserve validated lots up to 36 months for reproducible long-term workflows.
Full Documentation
CoA, TSE/BSE statement, CoO and SDS — from ISO 9001 and ISO 13485 certified partner facilities. Additional documents on request.
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 makes rHSA Premium Grade different from rHSA Economy Grade?
rHSA Premium Grade is purified via a three-step chromatography process to ≥99% purity (SDS-PAGE) with endotoxin <0.125 EU/mg — making it suitable for serum-free cell culture, ATMP manufacturing, and stringent IVD applications where endotoxin <1 EU/mg is required. rHSA Economy Grade uses single-step chromatography and reaches 90–99% purity with endotoxin <5 EU/mg — sufficient for IVD blocking reagents, diagnostic matrix proteins, and cosmetic formulations where the tighter endotoxin specification is not required. Both grades are expressed in rice endosperm, fully animal-free and TSE/BSE-free.
Is rHSA Premium Grade suitable for GMP ATMP and cell therapy manufacturing?
rHSA Premium Grade is supplied as RUO (Research Use Only) and is widely used in pre-GMP and GMP-compatible process development for CAR-T, NK cell, and MSC expansion protocols. With endotoxin <0.125 EU/mg, ≥99% purity, and full TSE/BSE documentation, it meets the critical quality attributes required in most xeno-free ATMP media formulations. For formal GMP manufacturing requiring a GMP drug master file, contact our team to discuss documentation and supply chain options.
Can rHSA Premium Grade replace plasma-derived HSA in cryopreservation media?
Yes — rHSA Premium Grade is a direct functional replacement for plasma-derived human serum albumin in cryopreservation formulations. It eliminates the lot-to-lot variability, TSE/BSE risk, and viral safety burden associated with blood-derived HSA. Its defined purity and ultra-low endotoxin make it the preferred choice for GMP-compatible freeze media in cell therapy and biobanking applications.
What pack sizes are available and is batch reservation possible?
rHSA Premium Grade is available as lyophilised powder in 10 g, 100 g, and 500 g pack sizes. Batch reservation is available for up to 36 months — contact our team with your required volume and project timeline to reserve a validated lot across your production programme. Custom quantities may be available on request.
What documentation is supplied with rHSA Premium Grade?
Every order includes a Certificate of Analysis (CoA) with lot-specific test results. Additional documentation — including TSE/BSE statements, Certificate of Origin (CoO), Safety Data Sheet (SDS), and sterility certificates — is available on request. Products are manufactured at ISO 9001 and ISO 13485 certified partner facilities.
Request a Quote or Sample
48h response · EU & Swiss Supply · Batch reservation available · Full documentation
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