Pichia Pastoris RHSA Recombinant Human Albumin Medical Embedding Reagent Plasma Free

recombinant human albumin rHSA medical device coating medical embedding reagent

Product Introduction

Anrate ARTrHA recombinant human albumin is produced via Pichia pastoris expression system. It acts as high-performance embedding and coating substrate tailored for vascular stents, interventional catheters, implant consumables and biosensors. It can fully replace plasma-derived human albumin and bovine serum albumin (BSA), eliminate fundamental biosafety hazards, and significantly boost clinical compatibility and long-term operational stability of medical devices.

 I.Plasma-Free & Animal-Free, Premium Medical Safety Standard

100% plasma-free and animal-free raw materials with yeast fermentation & purification process, blocking contamination risks of HBV, HIV, prion and other pathogens. Endotoxin level ＜0.01EU/mg, compliant with GMP specifications for Class III medical device excipients. Ultra-low immunogenicity effectively lowers postoperative inflammation, immune rejection and thrombosis complications after implantation.

II.Ultra-High Purity, Uniform Coating & Stable Manufacturing Process

Protein purity reaches ≥99.99%, with molecular spatial structure identical to native human albumin. It boasts excellent surface adsorption and coating capacity; a small dosage can fully cover both hydrophilic and hydrophobic surfaces of devices. Minimal batch-to-batch deviation ensures consistent quality in mass production, overcoming unstable activity fluctuations of plasma albumin batches, and perfectly fits automatic assembly line embedding and coating workflows.

III.Superior Biocompatibility, Anti-Thrombosis & Anti-Protein Adhesion

Leveraging albumin’s natural interface protection property, it forms a flexible biological protective film on device surfaces after embedding. It inhibits fibrin adsorption and platelet aggregation, drastically reducing thrombosis when stents and blood catheters interact with blood. It features anti-oxidation as well as pH and osmotic pressure buffering performance, protecting functional coatings and extending the in-vivo service lifespan of implanted medical devices.

IV.Wide Application Coverage

• Interventional Consumables: Coating & embedding for cardiac stents, vascular balloons, dialysis tubes and blood catheters
• Orthopedic & Soft Tissue Implants: Surface modification and coating for implant substrates
• In Vitro Diagnostics (IVD): Blocking and embedding for microfluidic chips, magnetic beads, biosensors
• Pathology Research: Protein fixation and embedding for frozen tissue sections

V.Mass Production, Formulations & Registration Support

Anrate owns a national-level recombinant protein industrial base with stable hundred-ton mass production, supply capacity free from plasma raw material limitations. Two formulations available: 20% sterile aqueous solution and high-purity lyophilized powder. Customizable concentration and sterile packaging are supported. Complete COA test reports are provided per batch, alongside full sets of registration technical documents to help overseas manufacturers accelerate medical device certification approval.