CellGenix® rh IL-1β
GMP and Preclinical grade
CellGenix Recombinant Human IL-1β reliably stimulates the maturation of immature dendritic cells (DCs). It in addition promotes the generation of megakaryocytes derived from pluripotent stem cells (PSCs). CellGenix rh IL-1β is produced in our dedicated animal-free facility ensuring maximum safety for optimal use in ATMP manufacturing.
General Information
Interleukin-1 beta (IL-1β) is a proinflammatory cytokine that is mainly produced by monocytes and activated macrophages as a proprotein. Inflammatory responses are mediated by IL-1β in T cells, natural killer cells (NK cells) and B cells. It induces the production of pro-inflammatory cytokines (IL-2, IL-3, IL-6) as well as interferons. Furthermore, IL-1β modulates the secretion of cytokines by various subsets of human DCs.
CellGenix IL-1β is used in the cell and gene therapy space for the ex vivo maturation of immature DCs.
GMP Grade
CellGenix GMP Recombinant Human IL-1β 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-1 beta
Source
E. coli
Formulation
Lyophilized
ANIMAL-DERIVED COMPONENT-FREE
CellGenix® GMP rh IL-1β
CellGenix® Preclinical rh IL-1β
CellGenix® rh IL-1β
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-1β, accession # P01584, Ala117-Ser269
Formulation
Lyophilized from 200 µl of a 0.2 µm-filtered solution containing 1.5 mM potassium phosphate, 8.1 mM sodium phosphate, 2.7 mM potassium chloride and 137 mM sodium chloride, 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 | 17.5 kDa | 17.5 kDa |
| Purity | ≥ 95% as determined by SDS-PAGE | ≥ 97% as determined by SDS-PAGE |
| Activity | ≥ 100 x 106 IU/mg, calibrated against NIBSC #86/680
Measured in a cell proliferation assay using an IL-1β sensitive cell line, RPMI 1788 | 70- 210 x 106 IU/mg, calibrated against NIBSC #86/680
Measured in a cell proliferation assay using an IL-1β sensitive cell line, D10.G4.1Batch specific activity on CoA |
| Endotoxin level | < 1000 EU/mg | ≤ 50 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.
Avoid repeated freeze/thaw cycles.
Data
CellGenix GMP rh IL-1β has an activity of 70 – 210 × 106 IU/mg
The activity of GMP rh IL-1β was measured in a cell proliferation assay using the IL-1β-dependent cell line D10.G4.1. It was calibrated against NIBSC #86/680.
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
- Tumor antigen–specific T cells for immune monitoring of dendritic cell–treated glioblastoma patients
Müller, I. et al., 2016, Cytotherapy - Autocrine CCL19 blocks dendritic cell migration toward weak gradients of CCL21
Hansen, M. et al., 2016, Cytotherapy - Inhibition of TNF receptor signaling by anti-TNF-a biologicals primes naive CD4+ T cells towards IL-10+ T cells with a regulatory phenotype and function
Books, MA. et al., 2014, Clinical Immunology - Comparison of clinical grade type 1 polarized and standard matured dendritic cells for cancer immunotherapy
Hansen, M. et al., 2013, Vaccine - Melanoma immunotherapy using mature DCs expressing the constitutive proteasome
Danull, J. et al., 2013, The Journal of Clinical Investigation - Low-dose temozolomide before dendritic-cell vaccination reduces (specifically) CD4+CD25++Foxp3+ regulatory T-cells in advanced melanoma patients
Ridolfi, L. et al., 2013, Journal of Translational Medicine - In-chip fabrication of free-form 3D constructs for directed cell migration analysis
Olsen, MH. et al., 2013, Lab on a Chip - The natural killer cell response and tumor debulking are associated with prolonged survival in recurrent glioblastoma patients receiving dendritic cells loaded with autologous tumor lysates
Pellegatta, S. et al., 2013, Oncoimmunology - An optimized method for manufacturing a clinical scale dendritic cell-based vaccine for the treatment of glioblastoma
Nava, S. et al., 2012, PloS One - A phase II study evaluating the safety and efficacy of an adenovirus-DLMP1-LMP2 transduced dendritic cell vaccine in patients with advanced metastatic nasopharyngeal carcinoma
Chia, WK. et al., 2012, Annals of Oncology - Unexpected high response rate to traditional therapy after dendritic cell-based vaccine in advanced melanoma: update of clinical outcome and subgroup analysis)
Ridolfi, L. et al., 2010, Clinical and Developmental Immunology
