Beijing Anrate Biotechnology Co., Ltd.
                                                                                                           
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FDA Recombinant HSA Human Serum Albumin For Cell Cryopreservation Animal Free

Price Negotiable
Price: Negotiable
MOQ: 1kg
Delivery Time: 28
Brand: Anrate
Product Description

ART101S Recombinant Human Albumin: The Gold Standard for Cell Cryopreservation, Safeguarding Biopharmaceutical Development


Key Advantages at a Glance

Animal-component-free, ultra-high purity (99.98%), low endotoxin (≤0.1 EU/mg) and batch-to-batch CV < 3%. It raises post-thaw cell viability to over 90% and enables DMSO concentration reduced to below 2.5%. Fully compliant for applications from academic research to clinical-grade production.

Produced by Pichia pastoris expression system, this product is free of blood-borne viruses, mycoplasmas, prions and all animal-derived components. It prevents impurity interference, fits serum-free & animal-component-free cell culture systems, and delivers a stable, pure culture environment with minimized experimental variables.

I. ART101S: Redefine the Standard of Cell Cryoprotection

Developed by Anrate, ART101S recombinant human albumin is the world’s first approved injectable-grade recombinant human albumin. It is specially engineered to tackle bottlenecks in cell cryopreservation and delivers three revolutionary improvements.

Maximum Safety: 100% Animal-component-free Protection

  • Produced via Pichia pastoris expression system, free from blood-borne viruses, mycoplasma and prions (TSE/BSE) risks.
  • Serum-free and animal-component-free, completely eliminating foreign protein contamination and immunogenic risks.
  • Manufactured under full GMP compliance, meeting regulatory requirements of the FDA, NMPA and other global authorities, and supporting clinical trial applications.

II. Application Scenarios: Full Compatibility from R&D to Clinical Production

Cell Therapy (CAR-T, NK, MSCs and other cell products)

  • Clinical-grade cell cryopreservation: Enables standardized serum-free & animal-component-free workflows to support FDA, NMPA clinical trial filings.
  • Lower adverse reactions: Low-DMSO formulations reduce side effects in patients after cell infusion and improve treatment safety.
  • Long-distance cold chain stability: Enhances cell stability during transportation between liquid nitrogen (-196°C) and -80°C storage.

 Vaccines & Biopharmaceuticals

  • Cell bank establishment: Ideal for long-term preservation of production cell lines such as CHO and HEK293, guaranteeing stability of master and working cell banks.
  • Viral vector cryopreservation: Protects activity of adenovirus, lentivirus and other viral vectors to improve transfection efficiency.
  • Vaccine manufacturing: Acts as a lyoprotectant to maintain antigen conformation and immunogenicity.

Academic Research & Stem Cell Research

  • Stem cell cryopreservation: Preserve pluripotency of ESCs and iPSCs and retain differentiation potential.
  • Primary cell preservation: Protect fragile primary cells (neurons, hepatocytes, etc.) and raise post-thaw viability.
  • 3D organoid cryopreservation: Maintain structural integrity of complex organoids for regenerative medicine research.

 III.Application Protocol: Efficient & Easy-to-use Cryopreservation Formulation

Recommended Cryopreservation Medium Formulation (Suitable for most cell types)

Component Final Concentration Function
ART101S Recombinant Human Albumin 5–10% Core cryoprotectant for membrane stabilization and anti-freeze protection
DMSO (Dimethyl Sulfoxide) 2.5–5% Auxiliary cryoprotectant with minimized toxicity
Basal Culture Medium Q.S. Maintain physiological environment of cells
Glucose 0.1–0.2 M Supply energy and regulate osmotic pressure

Standard Operating Procedures

1.Cell collection: Harvest cells in logarithmic growth phase; centrifuge at 300 g for 5 minutes to avoid cell damage from over-centrifugation.

2.Medium preparation: Mix all components at room temperature and ensure ART101S is fully dissolved.

3.Cell resuspension: Resuspend cells at a density of (1 times 10*6 sim 5 times 10*6) cells/mL; pipette gently to avoid bubble formation.

4.Freezing procedure

  • For research use: 4°C (10 min) → -20°C (30 min) → Store overnight at -80°C → Long-term storage in liquid nitrogen.
  • For clinical use: Use a controlled-rate freezer to cool cells at -1°C/min down to -80°C, then transfer to liquid nitrogen for long-term storage.

5.Thawing protocol: Thaw rapidly in a 37°C water bath (1–2 min). Gradually add pre-warmed complete medium, then centrifuge to remove DMSO.

4. Why Choose Anrate ART101S?

✅ Premium global quality: The world’s first approved injectable-grade recombinant human albumin. Completed FDA pre-submission and initiated BLA application in the US.
✅ Reliable supply: World-class production capacity of 50 tons, with single-batch output up to hundreds of kilograms to support continuous R&D and commercial production.
✅ Professional technical support: Dedicated application team provides customized cryopreservation protocols, free sample evaluation and process optimization services.
✅ Full regulatory compliance: Complete quality documentation package available for Master File (DMF) filing and clinical trial submissions.

Take Action Now — Elevate Your Cell Cryopreservation Performance

Target Customers

Cell therapy enterprises, vaccine R D institutions, biopharmaceutical companies, stem cell banks and academic research institutes.
Note: This product is intended exclusively for scientific research, laboratory and manufacturing purposes. It is not for clinical use, nor for application in animals or humans.

Feel free to contact us

WhatsApp: +85363312841 | Email: sales@bjanrate.cn

 

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Company Beijing Anrate Biotechnology Co., Ltd.
Location 4th Floor, Building 2, Courtyard 8, Haiying Road, Fengtai District, Beijing
Contact Person Li

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