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Your Position: Home > Protein > BMP-4 > GMP-BM4H18

GMP Human BMP-4 / BMP2B (improved sequence) Protein DMF

PG version BM4-H5118 is now available for seamless transition.
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  • Features
    1. Designed under ISO 9001:2015 and ISO 13485:2016

    2. Manufactured and QC tested under a GMP compliance factory

    3. FDA DMF filed

    4. Animal-Free materials

    5. Beta-lactam materials free

    6. Batch-to-batch consistency

    7. Stringent quality control tests

    8. No animal derived peptone and lactose used in production process

  • Source
    GMP Human BMP-4 (improved sequence) Protein (GMP-BM4H18) is expressed from E. coli cells. It is a variant of BMP-4 to suit cell culture applications better.
    Predicted N-terminus: Met
  • Molecular Characterization

    This protein carries no "tag".

    The protein has a calculated MW of 13.2 kDa. The protein migrates as 13 kDa±3 kDa when calibrated against Star Ribbon Pre-stained Protein Marker under reducing (R) condition (SDS-PAGE).

  • Endotoxin
    Less than 50 EU/mg by the LAL method / rFC method.
  • Host Cell Protein
    <0.5 ng/µg of protein tested by ELISA.
  • Host Cell DNA
    <0.02 ng/μg of protein tested by qPCR.
  • Sterility
    The sterility testing was performed by membrane filtration method described in USP<71> and Ph. Eur. 2.6.1.
  • Mycoplasma
    Negative.
  • Purity

    >95% as determined by SDS-PAGE.

  • Formulation

    Lyophilized from 0.22 μm filtered solution in 20 mM Citric acid, pH2.2 with protectants.

    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.
SDS-PAGE
BMP-4 SDS-PAGE

GMP Human BMP-4 (improved sequence) Protein on SDS-PAGE under reducing (R) condition. The gel was stained with Coomassie Blue. The purity of the protein is greater than 95% (With Star Ribbon Pre-stained Protein Marker).

Bioactivity-CELL BASE
 BMP-4 CELL

GMP Human BMP-4 (improved sequence) Protein (Cat. No. GMP-BM4H18) stimulates Human BMP (Luc) HEK293 Reporter Cell. The specific activity of GMP Human BMP-4 (improved sequence) Protein is > 1.90 x 10^3 U/mg (QC tested).

Application Data
 BMP-4 APPLICATION DATA

GMP Human BMP-4 (improved sequence) Protein (Cat. No. GMP-BM4H18) could significantly induce iPSC derived HSPC differentiation, with high expression of CD34 and CD45 (HSPC markers) by flow cytometry analysis and the increase of viable numbers of CD34+ CD45+ cells by cell counting. GMP Human BMP-4 (improved sequence) Protein (Cat. No. GMP-BM4H18) has a similar performance with Human BMP-4 (improved sequence) Protein, premium grade (Cat. No. BM4-H5118).

Bioactivity-Stability
 BMP-4 STABILITY

The Cell based assay shows that GMP Human BMP-4 (improved sequence) Protein (Cat. No. GMP-BM4H18) is stable at 37°C for 7 hours.

 BMP-4 STABILITY

The Cell based assay shows that GMP Human BMP-4 (improved sequence) Protein (Cat. No. GMP-BM4H18) is stable after freezing and thawing 3 times.

 BMP-4 STABILITY

The Cell based assay shows batch-to-batch consistency between Acro's GMP and PG BMP-4 (improved sequence).

  • 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
    Bone Morphogenetic Protein 4 (BMP4) is a member of growth factor of the TGF-beta superfamily that plays essential roles in many developmental processes, including neurogenesis, vascular development, angiogenesis and osteogenesis. BMP-4 Initiates the canonical BMP signaling cascade by associating with type I receptor BMPR1A and type II receptor BMPR2. BMP-4 can acts in concert with PTHLH/PTHRP to stimulate ductal outgrowth during embryonic mammary development and to inhibit hair follicle induction.
  • Clinical and Translational Updates

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Datasheet & Documentation

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