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Animal-Free Recombinant Proteins for CGT Manufacturing

50-Ton Annual rHSA Capacity. Animal-Free. Industrial Scale.

Animal-Free Recombinant Proteins for CGT Manufacturing

50-Ton Annual rHSA Capacity. Animal-Free. Industrial Scale.

Animal-Free Recombinant Proteins for CGT Manufacturing

50-Ton Annual rHSA Capacity. Animal-Free. Industrial Scale.

Animal-Free Recombinant Proteins for CGT Manufacturing

50-Ton Annual rHSA Capacity. Animal-Free. Industrial Scale.

  • ART101S Recombinant Human Serum Albumin(Ultra Pure, Solid)
    ART101S Recombinant Human Serum Albumin(Ultra Pure, Solid)
    ART101S Recombinant Human Serum Albumin(Ultra Pure, Solid)
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  • ART101S Recombinant Human Serum Albumin(Ultra Pure, Solid)

    ART101S Recombinant Human Serum Albumin (Ultra Pure, Solid) is manufactured to pharmacopoeia-grade formulation, expressed in Pichia pastoris using an animal-free production system, with HCP ≤ 10 ng/g. It is suitable for stem cell (MSC, ESC, iPSC) culture, immune cell (NK, T cell) culture, and cell therapy process development, and can also serve as a biopharmaceutical excipient for drug formulation. With an ultra-low impurity background, it provides a safe albumin component for serum-free/low-serum media and pharmaceutical formulations. Lyophilized powder form, shelf life 36 months at 2–8°C.

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    Product Introduction

    ART101S Recombinant Human Serum Albumin (Ultra Pure, Solid) is manufactured to pharmacopoeia-grade formulation, expressed in Pichia pastoris using an animal-free production system, with HCP ≤ 10 ng/g. It is suitable for stem cell (MSC, ESC, iPSC) culture, immune cell (NK, T cell) culture, and cell therapy process development, and can also serve as a biopharmaceutical excipient for drug formulation. With an ultra-low impurity background, it provides a safe albumin component for serum-free/low-serum media and pharmaceutical formulations. Lyophilized powder form, shelf life 36 months at 2–8°C.



    Background

    Human serum albumin (HSA) is synthesized by hepatic parenchymal cells and is the most abundant protein in human plasma. It functions as a carrier for fatty acids, amino acids, and other nutrients, while regulating plasma pH and maintaining plasma oncotic pressure. Recombinant human albumin (ARTrHA) is a recombinant human serum albumin expressed and purified from Pichia pastoris using genetic recombination technology. ARTrHA does not contain animal-derived components, carries no risk of blood-borne virus infection, and has high batch-to-batch stability. It can be used as an excipient to replace serum-derived albumin and has a variety of applications in biomedical fields.

    Product Advantages

    • Pichia pastoris-derived, green manufacturing, animal-free

    • No TSE/BSE, no antibiotic contamination

    • ISO 9001:2015 certified

    • Manufactured and QC tested in a GMP-compliant facility

    • Multi-ton production scale, stable and reliable supply

    • Purity greater than 99.0%

    • High batch-to-batch consistency

    • Rigorous quality testing and release

    Product Specifications

    Parameter

    Specification

    Ordering   Information

    Product   Name

    Recombinant   Human Albumin, rHA

    Synonyms

    Recombinant   Human Serum Albumin, Albumin, rHSA, HSA, ALB, Albumin

    Product   Number

    ART101S

    Specification

    10   g, 100 g

    Specification   Parameters

    CAS

    70024-90-7

    MDL

    MFCD00081418

    Source   of Product

    Recombinant   Pichia pastoris

    Appearance

    Off-white   loose powder

    Protein   Content

    95.0–110.0%

    Purity

    ≥   99.0% (USP-NF2023)

    HCP

    ≤   10 ng/g (ELISA)

    Molecular   Weight

    66.5±6.7   kDa

    pH

    6.4–7.4

    Endotoxin

    ≤   0.5 EU/mg


    Directions for Use

    This product is in lyophilized powder form. It is recommended to reconstitute with sterile PBS or other suitable buffer to prepare a stock solution at 200 mg/mL.

    After complete dissolution, further dilute to working concentration using culture medium. The sterile solution can be stored at 2–8°C for 36 months. Aliquot for single-use storage to avoid repeated freeze-thaw cycles, maintaining product activity and stability.

    Optimal albumin concentration may vary across different cell types and culture systems. Optimization and validation based on specific culture processes and experimental objectives are recommended to achieve the best culture results.

    Transport & Storage

    Ice pack transport.

    Store at 2–8°C, protected from light, moisture-proof, and sealed. Reconstituted sterile solutions are recommended to be aliquoted and stored at 2–8°C, stable for 36 months.

    Applications

    Recombinant human albumin (rHSA) consists of 585 amino acids, structurally identical to naturally circulating HSA, and performs multiple critical functions in cell culture: maintaining medium osmotic pressure, serving as a carrier for nutrients such as fatty acids and amino acids, scavenging free radicals to reduce oxidative stress, and providing cells with an in vitro growth environment free of blood-borne virus risk.

    Widely used in:

    • Mesenchymal stem cell (MSC) culture

    • Induced pluripotent stem cell (iPSC) culture

    • Embryonic stem cell (ESC) culture

    • NK cell, T cell, and other immune cell culture

    • CAR-T, CAR-NK cell therapy process development

    • Serum-free/low-serum medium core component

    • Biopharmaceutical excipient and drug formulation

    • Cell cryopreservation

    • In vitro diagnostics and vaccine production

    The pharmacopoeia-grade formulation and ultra-low HCP background (≤10 ng/g) ensure this product meets the stringent requirements of processes highly sensitive to impurities, such as cell therapy, while also complying with pharmaceutical-grade excipient standards.

    Precautions

    • This product is intended for research, process development, and biomanufacturing use only. Not for diagnostic, therapeutic, or clinical use in humans or animals.

    • Use the product as soon as possible after opening. Unused portions should be promptly sealed and stored under recommended conditions.

    • Maintain aseptic technique throughout reconstitution and handling to avoid microbial contamination.

    • Aliquot for single-use storage to avoid repeated freeze-thaw cycles that may compromise product activity.

    • Optimal albumin concentration may vary across different cell types and culture systems. Determine optimal usage conditions through preliminary experiments.

    • Read the product technical datasheet carefully before use and follow relevant experimental protocols.


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