Anrate is a professional original manufacturer of IVD biological raw materials in China, focusing on GMP grade recombinant human albumin (rHSA) and protein excipient R&D, mass production for in vitro diagnostic industry. We support full-chain services for IVD reagent development, industrial manufacturing, medical device registration and global FDA & CE export certification. Global IVD manufacturers face universal raw material drawbacks: traditional plasma derived human albumin has unstable global supply chain and volatile market price, with potential HBV, HIV blood-borne pathogen risks, which hinders raw material traceability and overseas medical device regulatory audit. Conventional bovine serum albumin (BSA) causes heterogeneous protein cross reaction, raises non-specific background noise, reduces detection accuracy of chemiluminescence, clinical biochemistry and POCT diagnostic kits. Large batch variation, short reagent shelf life and high QC rework rate also increase overall R&D and production cost for global IVD factories.
Anrate IVD grade recombinant human serum albumin (rHSA) is customized for in vitro diagnostic reagent production, adopting patented independent strain, eukaryotic expression system and five-stage chromatographic purification technology. This plasma-free and animal-free albumin removes impurity protein, endotoxin, host DNA and exogenous residues completely. As premium core IVD raw material, it is widely used for chemiluminescence immunoassay, clinical biochemical kit, fluorescence POCT, colloidal gold rapid test, ELISA, diagnostic calibrator and quality control serum production, complying with NMPA, CE, FDA international IVD medical device regulatory standards.
Core Product Advantages
I.Zero Biosafety Risk, Registration Compliance
Produced by full microbial biosynthesis process without human plasma and animal serum addition, Anrate rHSA eliminates blood pathogen contamination and heterogeneous antigen residue fundamentally. It meets global IVD reagent regulatory requirements and international biological safety inspection standards, simplifies raw material traceability and overseas product registration procedures, and accelerates global market access for in vitro diagnostic enterprises.
II.Ultra-high Purity, Optimized Signal-to-Noise Ratio
With protein purity ≥99% and ultra-low endotoxin index, the recombinant human albumin minimizes impurity protein and host cell residue. It effectively reduces non-specific immune binding and background noise of diagnostic detection, optimizes signal-to-noise ratio significantly compared with standard BSA, and maintains high biological activity of antigen and antibody. It is perfectly matched with high-precision IVD products including automated chemiluminescence immunoassay and fluorescence diagnostic reagents.
III.Multi-functional Excipient, Cost & Efficiency Optimization
This multi-functional IVD protein excipient can replace plasma albumin and BSA completely, serving as protein stabilizer, microplate blocking agent, clinical sample dilution matrix, enzyme protective agent, calibrator substrate and magnetic bead protective material. It stabilizes biological structure of antibody, antigen and active enzyme, slows down protein degradation, extends shelf life of in vitro diagnostic kits, cuts finished product scrappage and realizes formula optimization and cost reduction for IVD factories.
IV.Ultra-low Batch Difference, Industrial Mass Production Support
Produced in 100,000-class standardized GMP production workshop, Anrate rHSA achieves ultra-low batch-to-batch difference in physical and chemical indicators and protein activity, avoiding reagent quality drift and formula debugging troubles in large-scale production. The stable raw material performance adapts to industrial mass production and OEM customized production of global IVD brands.
IVD Application Scenarios
- Immunodiagnostic Reagents: Chemiluminescence reagents, ELISA kits, colloidal gold POCT, fluorescence rapid test reagents, buffer blocking and protein stabilization
- Clinical Biochemical Reagents: Liver function, blood lipid, glucose metabolism and renal function biochemical kits, buffer preparation and serum matrix replacement
- Calibrator & QC Material: Special rHSA for IVD calibrator, clinical quality control serum and artificial serum matrix preparation
- General IVD Excipient: Recombinant enzyme protection, bulk antibody storage, sample diluent and immunomagnetic bead coupling protection
- Global Export: FDA & CE compliant animal-free rHSA, raw material for overseas IVD brands and OEM production
| Product Namber |
Product Name |
formulation |
Purity |
Specifications |
| ART101S |
Recombinant Human Albumin |
Lyophilized powder |
≥99.0% |
10g 100g |
| ART101L |
Recombinant Human Albumin |
Liquid |
≥99.0% |
50ml 500ml |
| ART103S |
Recombinant Human Albumin |
Lyophilized powder |
≥99.0% |
10g 100g |
| ART103L |
Recombinant Human Albumin |
Liquid |
≥99.0% |
50ml 500ml |
| ART201S |
Recombinant Human Apo transferrin |
Lyophilized powder |
≥98.0% |
1g 10g 100g |
| ART202S |
Recombinant Human Holo transferrin |
Lyophilized powder |
≥98.0% |
1g 10g 100g |
Disclaimer
Intended solely for laboratory research, scientific trials and industrial manufacturing. Not for clinical use, nor for administration to humans or animals.
Feel free to contact us
WhatsApp: +85363312841 | Email: sales@bjanrate.cn
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