Recombinant Human IL-15 GMP Protein, CF

Animal-Free
  
  • Purity
    >97%, by SDS-PAGE with silver staining, under reducing conditions.
  • Endotoxin Level
    <0.10 EU per 1 μg of the protein by the LAL method.
  • Activity
    Measured in a cell proliferation assay using MO7e human megakaryocytic leukemic cells. The ED50 for this effect is 0.3-2.6 ng/mL.
    The specific activity of recombinant human IL-15 is approximately 4.5 x 105 U/μg, which is calibrated against recombinant human IL-15 WHO Standard (NIBSC code: 95/554).
  • Source
    E. coli-derived Asn49-Ser162 Produced using non-animal reagents in an animal-free laboratory.
    Manufactured and tested under current Good Manufacturing Practice (GMP) guidelines.
  • Accession #
  • N-terminal Sequence
    Analysis
    Asn-Trp-Val-Asn-Val-Ile-Ser-Asp-Leu-Lys
  • Predicted Molecular Mass
    12.5 kDa
247-GMP
 
Formulation Lyophilized from a 0.2 μm filtered solution in PBS.
Reconstitution Reconstitute at 100 μg/mL in PBS.
Shipping The product is shipped at ambient temperature. Upon receipt, store it immediately at the temperature recommended below.
Stability & Storage: Use a manual defrost freezer and avoid repeated freeze-thaw cycles.
  • 12 months, -20 to -70 °C as supplied.
  • 1 month, 2 to 8 °C under sterile conditions after reconstitution.
  • 3 months, -20 to -70 °C under sterile conditions after reconstitution.
Data Images

GMP-grade Recombinant Human IL-15 (Catalog # 247-GMP) stimulates cell proliferation in the MO7e human megakaryocytic leukemic cell line. The ED50 for this effect is 0.3-2.6 ng/mL.

1 μg/lane of GMP-grade Recombinant Human IL-15 (Catalog # 247-GMP) was resolved with SDS-PAGE under reducing (R) conditions and visualized by silver staining, showing a single band at 12 kDa.

Mass Spectrometry

MALDI-TOF analysis of GMP-grade Recombinant Human IL-15 (Catalog #
247-GMP). The major peak corresponds to the calculated molecular mass, 12774 Da. The minor peak at 13006 Da is a matrix-associated artifact of the MALDI-TOF.

Background: IL-15

R&D Systems' GMP proteins are produced according to relevant sections of the following documents: WHO TRS, No. 822, 1992 Annex 1, Good Manufacturing Practices for Biological Products; USP Chapter 1043, Ancillary Materials for Cell, Gene and Tissue-Engineered Products and USP Chapter 92, Growth Factors and Cytokines Used in Cell Therapy Manufacturing.

 

R&D Systems' quality focus includes:

  • Manufacturing and testing under an ISO 9001:2008 and ISO 13485:2003 certified quality system
  • Documented processes and QA control of documentation and process changes
  • Personnel training programs
  • Raw material testing and vendor qualification/monitoring
  • Fully validated equipment, processes and test methods
  • Equipment calibration schedules using a computerized calibration program
  • Facility maintenance, safety programs and pest control
  • Material review process for variances
  • Monitoring of stability over product shelf-life

 

R&D Systems strives to provide our customers with the analytical characteristics of each product so that customers may determine whether our products are appropriate for their research. The Certificate of Analysis provided contains the following lot specific information:

  • N-terminal amino acid analysis, SDS-PAGE analysis, and endotoxin level (as determined by LAL assay) performed on each bulk QC lot, not on individual bottlings of each QC lot
  • Post-bottling lot-specific bioassay results (compliance with an established range) and results of microbial bioburden testing (using broth culture, Sabourand's dextrose and blood agar plates with results reported at 3 days and at 7 days)

 

Additional testing and documentation requested by the customer can be arranged at an additional cost. Testing may include, but is not limited to, USP sterility testing, positive identity testing, testing for adventitious agents and testing for residual host cell content.

Production records and facilities are available for examination by appropriate personnel on-site at R&D Systems in Minneapolis, Minnesota USA.

R&D Systems sells its GMP grade recombinant protein products for research use or further manufacturing use in ex vivo cell therapy applications. They are not for in vivo use or for use as therapeutic or other drugs, biologic products or devices. Please read the following End User Terms prior to using this product.

 

Animal-Free Manufacturing Conditions
Our dedicated controlled-access animal-free laboratories ensure that at no point in production are the products exposed to potential contamination by animal components or byproducts. Every stage of manufacturing is conducted in compliance with R&D Systems' stringent Standard Operating Procedures (SOPs). Production and purification procedures use equipment and media that are confirmed animal-free.

Production

  • All molecular biology procedures use animal-free media and dedicated labware.
  • Dedicated fermentors are utilized in committed animal-free areas.

Purification

  • Protein purification columns are animal-free.
  • Bulk proteins are filtered using animal-free filters.
  • Purified proteins are stored in animal-free containers in a dedicated cold storage room.
    • Long Name:
      Interleukin 15
    • Entrez Gene IDs:
      3600 (Human); 16168 (Mouse); 25670 (Rat); 493682 (Feline)
    • Alternate Names:
      IL15; IL-15; IL-15MGC9721; interleukin 15; interleukin-15

    GMP Proteins
    R&D Systems' GMP proteins are produced according to relevant sections of the following documents: WHO TRS, No. 822, 1992 Annex 1, Good Manufacturing Practices for Biological Products; USP Chapter 1043, Ancillary Materials for Cell, Gene and Tissue-Engineered Products and USP Chapter 92, Growth Factors and Cytokines Used in Cell Therapy Manufacturing.

    R&D Systems' quality focus includes:
    • Manufactured and tested under an ISO 9001:2008 and ISO 13485:2003 certified quality system
    • Documented processes and QA control of documentation and process changes
    • Personnel training programs
    • Raw material testing and vendor qualification/monitoring
    • Fully validated equipment, processes and test methods
    • Equipment calibration schedules using a computerized calibration program
    • Facility maintenance, safety programs and pest control
    • Material review process for variances
    • Monitoring of stability over product shelf-life

    R&D Systems strives to provide our customers with the analytical characteristics of each product so that customers may determine whether our products are appropriate for their research. The Certificate of Analysis provided contains the following lot specific information:

    • N-terminal amino acid analysis, SDS-PAGE analysis, and endotoxin level (as determined by LAL assay) performed on each bulk QC lot, not on individual bottlings of each QC lot
    • Post-bottling lot-specific bioassay results (compliance with an established range) and results of microbial bioburden testing (using broth culture, Sabourand's dextrose and blood agar plates with results reported at 3 days and at 7 days)

    Additional testing and documentation requested by the customer can be arranged at an additional cost. Testing may include, but is not limited to, USP sterility testing, positive identity testing, testing for adventitious agents and testing for residual host cell content.

    Production records and facilities are available for examination by appropriate personnel on-site at R&D Systems in Minneapolis, Minnesota USA.

    R&D Systems sells its GMP grade recombinant protein products for research use or further manufacturing use in ex vivo cell therapy applications. They are not for in vivo use or for use as therapeutic or other drugs, biologic products or devices. Please read the following End User Terms prior to using this product.

    Animal-Free Manufacturing Conditions
    Our dedicated controlled-access animal-free laboratories ensure that at no point in production are the products exposed to potential contamination by animal components or byproducts. Every stage of manufacturing is conducted in compliance with R&D Systems' stringent Standard Operating Procedures (SOPs). Production and purification procedures use equipment and media that are confirmed animal-free.

    Production
    • All molecular biology procedures use animal-free media and dedicated labware.
    • Dedicated fermentors are utilized in committed animal-free areas.
    Purification
    • Protein purification columns are animal-free.
    • Bulk proteins are filtered using animal-free filters.
    • Purified proteins are stored in animal-free containers in a dedicated cold storage room.

    Please read our complete Animal-Free Statement

    END USER TERMS OF USE OF PRODUCT
    The following terms are offered to you upon your acceptance of these End User Terms of Use of Product. By using this product, you indicate your acknowledgment and agreement to these End User Terms of Use of Product. If you do not agree to be bound by and comply with all of the provisions of these End User Terms of Use of Product, you should contact your supplier of the product and make arrangements to return the product.

    We suggest you print and retain a copy of these End User Terms of Use of Product for your records.

    The End User is aware that R&D Systems, Inc. sells its GMP products for research use only or further manufacturing and not for in vivo use, the production of therapeutics or other drugs or for biologic products or devices. The End User further agrees, as a condition of the sale of R&D Systems'' GMP products that: a) the End User will not use this GMP Product in any procedure wherein the product may be directly or indirectly administered to humans, unless the End User has obtained, or prior to their use will have obtained, an Investigational New Drug (IND) exemption from the FDA and will use the product only in accordance with the protocols of such IND and of the Institutional Review Board overseeing the proposed research, or b) the End User will use the products outside of the United States in accordance with the protocols of research approved by the Institutional Review Board or authorized ethics committee and regulatory agencies to which the End User is subject to in their territory.

    R&D Systems, Inc. has the right, at its sole discretion, to modify, add or remove any terms or conditions of these End User Terms of Use without notice or liability to you. Any changes to these End User Terms of Use are effective immediately following the printing of such changes on this product insert. The most recent version of these End User Terms of Use of Product may be found at: RnDSystems.com/Legal-Information

    You agree to review these End User Terms of Use of Product to ensure any subsequent use by you of R&D Systems'' GMP Products following changes to these End User Terms of Use of Product constitutes your acceptance of all such changes.

    TERMS AND CONDITIONS
    The following limitation applies to R&D Systems'' warranty and liability for damages: All products are warranted to meet R&D Systems'' published specifications when used under normal laboratory conditions.

    R&D SYSTEMS DOES NOT MAKE ANY OTHER WARRANTY OR REPRESENTATION WHATSOEVER, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO ITS PRODUCTS. IN PARTICULAR, R&D SYSTEMS DOES NOT MAKE ANY WARRANTY OF SUITABILITY, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

    NOTWITHSTANDING ANY OTHER PROVISIONS OF THESE TERMS AND/OR ANY OTHER AGREEMENT BETWEEN R&D SYSTEMS AND PURCHASER FOR THE PURCHASE OF THE PRODUCTS, R&D SYSTEMS'' TOTAL LIABILITY TO PURCHASER ARISING FROM OR IN RELATION TO THESE TERMS, AN AGREEMENT BETWEEN THE PARTIES OR THE PRODUCTS, WHETHER ARISING IN CONTRACT, TORT OR OTHERWISE SHALL BE LIMITED TO THE TOTAL AMOUNT PAID BY PURCHASER TO R&D SYSTEMS FOR THE APPLICABLE PRODUCTS. IN NO EVENT WILL R&D SYSTEMS BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE GOODS.

    Full details of R&D Systems'' Terms and Conditions of Sale can be found online at: RnDSystems.com/Legal-Information

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