Login Register
icon_bulk_orderBulk order Acrobiosystems for English
0
There is no goods in the shopping cart !
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9
Your Position: Home > GMP > IL-15 > GMP-L15H13

GMP Human IL-15 DMF Filed

Recommended Hot Products: Human CD19 (20-291) Protein, Fc Tag, premium grade DMF Filed  Human Glypican 3 / GPC3 Protein, His Tag, premium grade  Human IL-15 Protein, premium grade 
ACROBiosystems has established the GMP grade facility and strict quality management system to support the clinical study of immune cell therapy. If you have any customized inquiries of GMP products, please click here to leave your message.
    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 IL-15(GMP-L15H13) is expressed from E.coli cells. It contains AA Asn 49 - Ser 162 (Accession # P40933-1 ).
    Predicted N-terminus: Met
  • Molecular Characterization
    IL-15 Structure

    This protein carries no "tag"

    The protein has a calculated MW of 12.8 kDa. The protein migrates as 12-13 kDa under reducing (R) condition (SDS-PAGE).

  • Endotoxin
    Less than 10 EU/mg by the LAL method.
  • Host Cell Protein
    <0.5 ng/μg of protein tested by ELISA.
  • Host Cell DNA
    <0.02 ng/μg of protein tested by DNA Fluorescent Staining method.
  • Sterility
    The sterility testing was performed by membrane filtration method described in CP<1101>, USP<71> and Eur. Ph. 2.6.1.
  • Mycoplasma
    Negative.
  • In vitro virus assay
    Negative.
  • Purity

    >95% as determined by SDS-PAGE.

  • Formulation

    Lyophilized from 0.22 μm filtered solution in 25 mM His, pH6.2 with trehalose as protectant.

    Contact us for customized product form or formulation.

  • Reconstitution

    Please see Certificate of Analysis for specific instructions.

    For best performance, we strongly recommend you to follow the reconstitution protocol provided in the CoA.

  • Storage

    Shipping at ambient temperature. 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 24 months in lyophilized state from date of receipt;
    2. -70°C for 12 months under sterile conditions after reconstitution.
SDS-PAGE
IL-15 SDS-PAGE

GMP Human IL-15 on SDS-PAGE under reducing (R) condition. The gel was stained overnight with Coomassie Blue. The purity of the protein is greater than 95%.

Bioactivity-Bioactivity CELL BASE
 IL-15 CELL

GMP Human IL-15 (Cat. No. GMP-L15H13) stimulates proliferation of CTLL-2 cells. The specific activity of GMP Human IL-15 is > 0.8ⅹ10^7 IU/mg, which is calibrated against human IL- 15 WHO International Standard (NIBSC code: 95/554) (QC tested).

Bioactivity-Stability
 IL-15 STABILITY

The Cell based assay shows that GMP Human IL-15 (Cat. No. GMP-L15H13) is stable at 37°C for 48 hours.

 IL-15 STABILITY

The Cell based assay shows that GMP Human IL-15 (Cat. No. GMP-L15H13) is stable at 4°C for 3 months under long-term real-time monitoring.

 IL-15 STABILITY

The Cell based assay shows that GMP Human IL-15 (Cat. No. GMP-L15H13) is stable after freezing and thawing 3 times.

  • 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
    Interleukin 15 is also known as IL15, IL-15, and is a cytokine with structural similarity to IL-2. Like IL-2, IL-15 binds to and signals through the IL-2/IL-15 beta chain (CD122) and the common gamma chain (gamma-C, CD132). IL-15 is secreted by mononuclear phagocytes (and some other cells) following infection by virus(es). This cytokine induces cell proliferation of natural killer cells; cells of the innate immune system whose principal role is to kill virally infected cells. Interleukin 15 (IL-15) regulates T and natural killer (NK) cell activation and proliferation. Survival signals that maintain memory T cells in the absence of antigen are provided by IL-15. This cytokine is also implicated in NK cell development. In rodent lymphocytes, IL-15 prevents apoptosis by inducing an apoptosis inhibitor, BCL2L1/BCL-x(L). IL-15 has been shown to enhance the anti-tumor immunity of CD8+ T cells in pre-clinical models. A phase I clinical trial to evaluate the safety, dosing, and anti-tumor efficacy of IL-15 in patients with metastatic melanoma and renal cell carcinoma (kidney cancer) has begun to enroll patients at the National Institutes of Health.
  • Clinical and Translational Updates
  • Please contact us via TechSupport@acrobiosystems.com if you have any question on this product.

Comments (0)


ETD of in-stock products: 2 business days

Price(USD) : $830.00

Price(USD) :


Price(USD) :


Request GMP Version

Promotion & Exhibitions



Drug Development Status

  • Number of Launched Drugs:0 Details
  • Number of Drugs in Clinical Trials:8 Details
  • Latest Research Phase:Phase 2 Clinical

Datasheet & Documentation

Request for DMF
DMF (Drug Master File)

Contact Us

+1  800-810-0816 (US)
+86 400-682-2521 (AP)

Related Products

New Product Launch

Questions & Comments

This web search service is supported by Google Inc.

totop
Call us
Call us
North America: +1 800-810-0816 (Toll Free)
Asia & Pacific: +86 400-682-2521
Fax
Fax
+1 888-377-6111
Address
Address
1 Innovation Way, Newark, DE 19711, USA

Leave a message