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Your Position: > Protein > Thrombopoietin > GMP-THNH25

GMP Human Thrombopoietin Protein

인기 제품 추천:
PG version THN-H5216 is now available for seamless transition.
This product is still under development. Please contact us if you have interest in this product. We will accelerate the development process accordingly and reserve this product for you as request.
  • Features
    1. Designed under ISO 9001:2015 and ISO 13485:2016

    2. Manufactured and QC tested under a GMP compliance factory

    3. Animal-Free materials

    4. Batch-to-batch consistency

    5. Stringent quality control tests

  • Source
    GMP Human Thrombopoietin Protein(GMP-THNH25) is expressed from human 293 cells (HEK293). It contains AA Ser 22 - Gly 353 (Accession # P40225-1).
    Predicted N-terminus: Ser 22
  • Molecular Characterization
    Thrombopoietin Structure

    This protein carries no "tag".

    The protein has a calculated MW of 35.5 kDa.

  • Sterility
    The sterility testing was performed by membrane filtration method described in CP<1101>, USP<71> and Eur. Ph. 2.6.1.
  • Mycoplasma
    Negative.
  • Formulation

    Please contact us for detailed information.

    Contact us for customized product form or formulation.

  • Shipping

    This product is supplied and shipped with blue ice, please inquire the shipping cost.

  • Storage

    Upon receipt, store it immediately at -20°C or lower for long term storage.

    Please avoid repeated freeze-thaw cycles.

    This product is stable after storage at:

    1. -20°C to -70°C for 5 years in lyophilized state;
    2. -70°C for 12 months under sterile conditions after reconstitution.
  • MANUFACTURING SPECIFICATIONS

    ACROBiosystems GMP grade products are produced under a quality management system and in compliance with relevant guidelines: Ph. Eur General Chapter 5.2.12 Raw materials of biological origin for the production of cell-based and gene therapy medicinal products; USP<92>Growth Factors and Cytokines Used in Cell Therapy Manufacturing; USP<1043>Ancillary Materials for Cell, Gene, and Tissue-Engineered Products; ISO/TS 20399-1:2018, Biotechnology - Ancillary Materials Present During the Production of Cellular Therapeutic Products.


    ACROBiosystems Quality Management System Contents:

    1. Designed under ISO 9001:2015 and ISO 13485:2016, Manufactured and QC tested under a GMP compliance factory.

    2. Animal-Free materials

    3. Materials purchased from the approved suppliers by QA

    4. ISO 5 clean rooms and automatic filling equipment

    5. Qualified personnel

    6. Quality-related documents review and approve by QA

    7. Fully batch production and control records

    8. Equipment maintenance and calibration

    9. Validation of analytical procedures

    10. Stability studies conducted

    11. Comprehensive regulatory support files

    Request For Regulatory Support Files(RSF)


    ACROBiosystems provide rigorous quality control tests (fully validated equipment, processes and test methods) on our GMP grade products to ensure that they meet stringent standards in terms of purity, safety, activity and inter-batch stability, and each bulk QC lot mainly contains the following specific information:

    1. SDS-PAGE

    2. Protein content

    3. Endotoxin level

    4. Residual Host Cell DNA content

    5. Residual Host Cell Protein content

    6. Biological activity analysis

    7. Microbial testing

    8. Mycoplasma testing

    9. In vitro virus assay

    10. Residual moisture
    11. Batch-to-batch consistency

  • Background
    Thrombopoietin (TPO) is a 332 amino acid glycoprotein made primarily in the liver and act as the major physiological regulator of platelet production. TPO binds the TPO receptor, activates JAK and STAT pathways, thus stimulating megakaryocyte growth and platelet production. Additionally, further investigation uncovered that thrombopoietin is a critical cytokine promoting hematopoietic rebound after myeloablation and its transcripts are expressed by multiple cellular sources.
  • Clinical and Translational Updates

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약물 개발 현황

  • Number of Launched Drugs:0 Details
  • Number of Drugs in Clinical Trials:0 Details
  • Latest Research Phase:Discontinued

Datasheet & Documentation

DMF 신청
DMF (Drug Master File)

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