CellGenix® rh IL-15
GMP and Preclinical grade
CellGenix Recombinant Human IL-15 reliably promotes the proliferation of T cells. It also stimulates the proliferation of natural killer cells (NK cells) and promotes the generation of cytokine-induced killer cells (CIK cells). CellGenix rh IL-15 is produced in our dedicated animal-free facility ensuring maximum safety for optimal use in ATMP manufacturing.
General Information
Interleukin-15 (IL-15) is a cytokine that plays an important role in humoral and adaptive immune responses. It induces or enhances the differentiation, maintenance, or activation of NK cells and multiple T cell subsets. IL-15 is produced by a large number of cell types, including monocytes, macrophages, dendritic cells, keratinocytes, fibroblasts and nerve cells.
IL-15 is used in the cell and gene therapy space for the ex vivo expansion of various T cells (CAR T cells, TCR T cells and TILs) as well as NK cells and the generation of CIK cells.
GMP Grade
CellGenix Recombinant Human IL-15 is produced following all applicable GMP guidelines and allows for the safe use in accordance with USP Chapter <1043> and Ph. Eur. General Chapter 5.2.12.
Our GMP cytokines are provided with documented evidence of purity, potency, consistency and stability. In combination with our expert regulatory and technical support this will help simplify your raw material qualification and validation efforts.
name
CellGenix® Recombinant Human Interleukin-15
Source
E. coli
Formulation
Lyophilized
ANIMAL-DERIVED COMPONENT-FREE
CellGenix® GMP rh IL-15
CellGenix® Preclinical rh IL-15
CellGenix® rh IL-15
Features
- Produced in our dedicated animal-free facility
- Compliant to USP Chapter <1043> and Ph. Eur. General Chapter 5.2.12 (GMP)
- FDA Drug Master File available (GMP)
GMP & Preclinical Grade
- Seamless transition from preclinical development to ATMP manufacturing
Applications
Highest GMP Quality Standard
- High lot-to-lot consistency – save time and costs on revalidations
- Performance reliability – rely on consistent product performance
- Highest purity – ensure the safety of your ATMP
- Extremely low endotoxin levels – improve safety and reproducibility
- Expert regulatory & technical support – rely on experience
Read more about our GMP Quality
Safe │ GMP Compliant │ Reliable
Technical Details
Source
Expressed in E. coli
Description
Human IL-15, accession # P40933, Asn49-Ser162
Formulation
Lyophilized from 200 µl of a 0.2 µm-filtered solution containing 20 mM potassium phosphate, 300 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.
| | Preclinical | GMP |
| Molecular weight | 13.7 kDa | 13.7 kDa |
| Purity | ≥ 95% as determined by SDS-PAGE | ≥ 97% as determined by SDS-PAGE |
| Activity | ≥ 8 x 106 IU/mg, calibrated against NIBSC #95/554
Measured in a cell proliferation assay using an IL-15-dependent cell line, CTLL-2 | 8 – 30 x 106 IU/mg, calibrated against NIBSC #95/554
Measured in a cell proliferation assay using an IL-15-dependent cell line, CTLL-2Batch specific activity on CoA |
| Endotoxin level | < 25 EU/mg | ≤ 25 EU/mg |
| Intended use | Intended 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.
Shipment
Ambient temperature. Please refer to Technote to learn more about our shipment validation procedure.
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.
Data
CellGenix GMP rh IL-15 has an activity of 8 – 30 × 106 IU/mg
The activity of GMP rh IL-15 was measured in a cell proliferation assay using the IL-15-dependent cell line CTLL-2. It was calibrated against NIBSC #95/554.
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 with the international guidelines for raw materials, we are in constant interaction with regulatory authorities worldwide. In this regard, we amongst others helped defining the European guidelines which are outlined in the new general chapter Ph. Eur. monograph 5.2.12.
Regulatory Resources
Publications
- In vivo Efficacy of umbilical Cord Blood Stem Cell-Derived NK Cells in the treatment of Metastatic Colorectal Cancer
Veluchamy, JP. et al., 2017, Frontiers in Immunology - CMV-specific T cells generated from naive T cells recognize atypical epitopes and may be protective in vivo
Hanley, PJ. et al., 2015, Science Translational Medicine - Lentivirus-induced “Smart” dendritic cells: Pharmacodynamics and GMP-compliant production for immunotherapy against TRP2-positive melanoma
Sundarasetty, BS. et al., 2015, Gene Therapy - Immunophenotypic and functional characterization of ex vivo expanded natural killer cells for clinical use in acute lymphoblastic leukemia patients
Peragine, N. et al., 2015, Cancer Immunology, Immunotherapy - Antigen-specific activation and cytokine-faciliated expansion of naive, human CD8+ T cells
Wölfl, M., Greenberg, PD., 2014, Nature Protocols - Recognition of adult and pediatric acute lymphoblastic leukemia blasts by natural killer cells
Torelli, GF. et al., 2014, Haematologica - Ex Vivo Activation of CD56+ Immune Cells That Eradicate Neuroblastoma
Rujkijyanont, P. et al., 2013, Cancer Research - Multiplex and Genome-Wide Analyses Reveal Distinctive Properties of KIR+ and CD56+ T Cells in Human Blood
Chan, WK. et al., 2013, Journal of Immunology - Validation of analytical methods in compliance with good manufacturing practice: a practical approach
Rustichelli, D. et al., 2013, Journal of Translational Medicine - Clinical-Grade Generation of Active NK Cells from Cord Blood Hematopoietic Progenitor Cells for Immunotherapy Using a Closed-System Culture Process
Spanholtz, J. et al., 2011, PloS One
