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CellGenix/CellGenix® rh IL-7/50µg/1010-050

Technical Details

Source
Expressed in E. coli
Description

Human Interleukin-7, accession # P13232, Asp26-His177

Formulation

Lyophilized from 200 µl of a 0.2 µm-filtered solution containing 25 mM sodium phosphate, 150 mM sodium chloride and 0.1 % polysorbate 20, pH 7.5

Both product grades are produced under the same conditions in a GMP facility, ensuring an equal product quality and performance. We offer a more comprehensive QC testing including tighter specifications and documentation for our GMP products: Preclinical vs GMP.

 PreclinicalGMP
Molecular weight18.3 kDa18.3 kDa
Purity≥ 95% as determined by SDS-PAGE≥ 97% as determined by SDS-PAGE
Activity≥ 50 x 106 IU/mg, calibrated against NIBSC #90/530 Measured in a cell proliferation assay using an IL-7-dependent cell line, IxN/2b50 – 200 x 106 IU/mg, calibrated against NIBSC #90/530 Measured in a cell proliferation assay using an IL-7-dependent cell line, IxN/2b

Batch specific activity on CoA

Endotoxin level< 25 EU/mg≤ 25 EU/mg
Intended useIntended for preclinical ex vivo use. Not intended for therapeutic use.Intended for clinical ex vivo use. Not intended for human in vivo application.

Handling Instructions

Reconstitution

Recommended in sterile water to a final concentration of 250 µg/ml for 50 µg vials.

Shipment

Ambient temperature. Please refer to Technote to learn more about our shipment validation procedure.

Expiry

≥ 6 months from date of shipping. Please refer to Certificate of Analysis for the exact expiry date.

Storage & Stability

Store lyophilized cytokine at -20°C to -80°C.

Store a 250 µg/ml reconstituted cytokine solution:

• 4 weeks at 2°C to 8°C under sterile conditions after reconstitution. Store in the original container. 

• 4 months at -20°C to -80°C under sterile conditions after reconstitution. Store in 60 µl aliquots in polypropylene cryogenic vials.

Avoid repeated freeze/thaw cycles.

Documents

  • Data Sheet: GMP or Preclinical
  • Material Safety Data Sheet: MSDS
  • Certificate of Analysis
  • Technote: ADCF and Serum-free Policy
  • Technote: Batch-to-Batch Consistency of CellGenix® GMP Cytokines
  • Technote: Stability of CellGenix® GMP Cytokines after Reconstitution
  • Technote: Shipment of CellGenix® Preclinical and GMP Cytokines at Ambient Temperatures
  • Technote: CellGenix® rh Cytokines - Preclinical vs GMP
  • More information under Resources

Data

 CellGenix GMP rh IL-7 has an activity of 50 – 200 × 106 IU/mg

The activity of GMP rh IL-7 was measured in a cell proliferation assay using the IL-7-dependent cell line IxN/2b. It was calibrated against NIBSC #90/530.

You can find the batch specific activity on the certificate of analysis (CoA).

Regulatory Support

We offer the following to assist you with your regulatory approval process:

  • Comprehensive documentation (e.g. DMFs, Regulatory Support Files, Certificates of Origin)
  • Outstanding QC support (e.g. extensive stability data)
  • The possibility to audit our production site
  • Detailed batch specific test results on our Certificates of Analysis
  • Change notifications prior to relevant changes

Customized solutions can be provided to meet special compliance needs. Contact our Regulatory Support Team for all your regulatory requests & questions:

Phone:     +49 761 88 88 9-302 Email:      regulatorysupport@cellgenix.com

In order to stay up-to-date and help improve regulatory guidance we are actively involved in many of the regulatory initiatives and discussions. We were amongst others actively involved in the discussions for the setup of Ph. Eur. General Chapter 5.2.12 and the ISO Technical Standard 20399.

Regulatory Resources

  • TSE certificate (available on request)
  • Regulatory Support File (available on request)
  • Request a DMF Letter of Authorization (USA only)

Publications

  • In vivo Efficacy of umbilical Cord Blood Stem Cell-Derived NK Cells in the treatment of Metastatic Colorectal CancerVeluchamy, JP. et al., 2017, Frontiers in Immunology
  • Lentivirus-induced “Smart” dendritic cells: Pharmacodynamics and GMP-compliant production for immunotherapy against TRP2-positive melanomaSundarasetty, BS. et al., 2015, Gene Therapy
  • IL-7 Abrogates the Immunosuppressive Function of Human Double-Negative T Cells by Activating akt/mTOR SignalingAllgäuer, A. et al., 2015, Journal of Immunology
  • Antigen-specific activation and cytokine-faciliated expansion of naive, human CD8+ T cellsWölfl, M., Greenberg, PD., 2014, Nature Protocols
  • Isolation of Highly Suppressive CD25+FoxP3+ T Regulatory Cells from G-CSF-Mogilized Donors with Retention of Cytotoxic Anti-Viral CTLs: Application for Multi-Functional Immunotherapy Post Stem Cell TransplantationSamuel ER. et al., 2014, Plos One
  • Natural killer cells generated from cord blood hematopoietic progenitor cells efficiently target bone marrow-residing human leukemia cells in NOD/SCID/IL2Rg(null) miceCany, J. et al., 2013, PloS One
  • Clinical-Grade Generation of Active NK Cells from Cord Blood Hematopoietic Progenitor Cells for Immunotherapy Using a Closed-System Culture ProcessSpanholtz, J. et al., 2011, PloS One
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