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CTGrade GMP rh IL-15 is a recombinant human protein that is produced from E. coli and is designed to support basic, translational, and clinical research, as well as commercial applications, and offers:
High biological activity verified by a relevant bioactivity assay
Low endotoxin levels
≥ 97% purity
High lot-to-lot consistency
Size: 50 µg, 100 µg, and 1 mg. Custom sizes and packaging available on request.
IL-15 is a widely expressed proinflammatory cytokine that is structurally and functionally related to IL-2.
Signals through JAK kinases to activate STAT3, STAT5, and STAT6 transcription factors
Regulates the activation of T cells, neutrophils, and macrophages, and is a stimulatory cytokine promoting dendritic cell function
Dysregulated in chronic inflammatory disorders, including rheumatoid arthritis, psoriasis, and pulmonary inflammatory diseases
Combines with other common γ chain cytokines (IL-2, IL-7 and IL-21) to promote favorable anti-tumoral phenotypes in adoptive cellular therapies such as CAR-T cell therapy
The biological activity of CTGrade GMP interleukins and growth factors is standardized, where applicable, to WHO International standards, providing cell and gene therapy developers consistent, lot-to-lot biological activity and performance.
The CTGrade GMP products are manufactured in a facility that does not use or process beta-lactam containing materials. No animal- or human-derived materials were used during manufacturing or as ingredients. These products are manufactured, tested, and released in an ISO 9001:2015 certified facility following cGMP practices. USP chapter <1043> for ancillary materials has been considered in the manufacture of these products.
SDS-PAGE Showing a Single
Prominent Band at 6 kDa
Figure 1. CTGrade GMP rh IL-15 (1 μg) was resolved with SDS-PAGE under non-reducing (NR) and reducing (R) conditions and visualized by InstantBlue staining showing a single prominent band at 6 kDa. Predicted MW is 12.9 kDa, but runs on SDS-PAGE at ~6 kDa.
Cell-Based Proliferation Assay
Figure 2. The biological activity of CTGrade GMP rh IL-15 was determined in a CTLL-2 cell-based proliferation assay.
CTGrade GMP rh IL-15 lyophilized at 1 mg/ml in 10 mM Sodium Bicarbonate, pH 8.0, 0.2 µm filtered
Protein Purity
≥ 97% determined by reducing and non-reducing SDS-PAGE analysis
Endotoxin
< 0.05 EU/µg using USP <85> / EP 2.6.14
Bioactivity
ED50 is determined by the dose-dependent proliferation of CTLL-2 cells. The ED50 is typically less than 1 ng/mL. The international units of CTGrade GMP rh IL-15 is approximately 2.7 x 105 IU/µg, which is calibrated against recombinant human interleukin 15 WHO International Standard (NIBSC code 95/544).
Quality
Carrier-free and no animal- or human-derived materials were used during manufacturing
*Animal component-free to the tertiary level (no animal components or sub-components are used in the product, raw materials, including packaging or the manufacturing process). Supporting documentation available upon request.
**For research use or further manufacturing and in ex vivo cell therapy applications.
***Lot-specific values for the following specifications are supplied with each product on its corresponding COA. The values provided here are minimum expected values to pass internal requirements.
Specifications
Storage
This product is shipped at ambient temperature. Immediately upon receipt, store the lyophilized protein at -20°C in a manual defrost freezer.
Shelf Life
Unopened vials are stable for 36 months from the date of manufacture as indicated on the label. Reconstituted material should be apportioned in working volumes and stored at or below -20°C in manual defrost freezer. For short term storage reconstituted material is stable for 4-6 weeks when stored at 2-8°C. Stability can be increased by adding at least 0.1% carrier protein.
