CellGenix® rh IL-2
GMP and Preclinical grade
CellGenix Recombinant Human IL-2 reliably activates and expands T cells, natural killer cells (NK cells) and cytokine-induced killer cells (CIK cells). CellGenix rh IL-2 is produced in our dedicated animal-free facility ensuring maximum safety for optimal use in ATMP manufacturing.
General Information
Interleukin-2 (IL-2) is a cytokine signaling molecule that is mainly produced by T cells. It is a central regulator of immune responses and plays a role in anti-inflammatory reactions, hematopoiesis and tumor surveillance.
IL-2 is used in the cell and gene therapy space to promote proliferation and differentiation of CAR T cells, TCR T cells, Tregs, TILs, NK cells and CIK cells.
GMP Grade
CellGenix GMP Recombinant Human IL-2 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-2
Source
E. coli
Formulation
Lyophilized
ANIMAL-DERIVED COMPONENT-FREE
CellGenix® GMP rh IL-2
50 µg
1020-050
1 mg
1020-1000
CellGenix® Preclinical rh IL-2
CellGenix® rh IL-2
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
- Activation and expansion of T cells, NK cells and CIK cells
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-2 with a substitution of cysteine-125 by serine, accession # P60568, Pro22-Thr153
Formulation
Lyophilized from a 0.2 µm-filtered solution containing 25 mM sodium acetate and 50 mM sodium chloride, pH 5.0
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 | 16.3 kDa | 16.3 kDa |
| Purity | ≥ 95% as determined by SDS-PAGE and HPLC | ≥ 97% as determined by SDS-PAGE and HPLC |
| Activity | ≥ 8 x 106 IU/mg, calibrated against Proleukin®
Measured in a cell proliferation assay using an IL-2-dependent cell line, CTLL-2 | 8 – 32 x 106 IU/mg, calibrated against Proleukin®
Measured in a cell proliferation assay using an IL-2-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 0.2% acetic acid to a final concentration of 250 µg/ml for 50 µg vials or 500 µg/ml for 1 mg vials.
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-2 has an activity of 8 – 32 × 106 IU/mg
The activity of GMP rh IL-2 was measured in a cell proliferation assay using the IL-2-dependent cell line CTLL-2. It was calibrated against Proleukin®.
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
