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Shenandoah CTGrade GMP rh IL-2C126S 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.
The core amino acid sequence and 126 C to S sequence of CTGrade GMP rh IL-2 are identical to Proleukin
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-2C126S is an immunomodulatory cytokine that is produced by lymphocytes. IL-2C126S signals through the IL-2R receptor to induce activated T cell proliferation and promote T cell differentiation.
Stimulates the proliferation and differentiation of B cells, natural killer (NK) cells, monocytes, and macrophages
Promotes proliferation and differentiation of CAR T cells, T cells, and NK cells
Activates and expands T cells and NK cells from peripheral blood
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 GMP. USP chapter <1043> for ancillary materials has been considered in the manufacture of these products.
SDS-PAGE Showing a Single Prominent Band at 14 kDa
Figure 1. CTGrade GMP rh IL-2C126S (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 14 kDa. Predicted MW is 15.5 kDa, but runs on SDS-PAGE at ~14kDa.
Cell-based Proliferation Assay
Figure 2. The biological activity of CTGrade GMP rh IL-2C126S was determined in a CTLL-2 cell-based proliferation assay.
Lot-to-lot Consistency
Figure 3. CTGrade GMP rh IL-2C126S induces proliferation in CTLL-2 cells that is consistent between lots.
Bioactivity Comparison between CTGrade GMP rh IL‑2C126S and RUO rh IL‑2C126S
Figure 4. Bioactivity comparison between CTGrade GMP rh IL-2C126S and RUO rh IL-2C126S.
Lot-to-lot Bioactivity Comparison with Commercially-available GMP IL-2
Figure 5. Bioactivity comparison between CTGrade GMP rh IL-2C126S and commercially-available GMP IL-2.
CTGrade GMP rh IL-2C126S lyophilized at 1 mg/ml in 0.1% Trifluoroacetic Acid (TFA), 0.2 µm filtered
Protein Purity
≥ 97% determined by reducing and non-reducing SDS-PAGE analysis
Endotoxin
< 0.01 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 3 ng/mL. The international units of CTGrade GMP rh IL-2C126S is approximately 1.17 x 104 IU/µg, which is calibrated against recombinant human interleukin 2 WHO International Standard (NIBSC code 86/500).
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.
