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Shenandoah CTGrade GMP rh IL-10 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.
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-10 is an anti-inflammatory cytokine produced by macrophages and type 2 T helper (Th2) cells.
Inhibits the production of pro-inflammatory cytokines such as interferon gamma (IFNγ), tumor necrosis factor alpha (TNFα), interleukin 2 (IL-2), interleukin 3 (IL-3), interleukin 4 (IL-4), and granulocyte-macrophage colony-stimulating factor (GM-CSF), made by macrophages and regulatory T cells
Suppresses antigen presentation on antigen presenting cells, and enhances the survival, proliferation, and antibody production of B cells
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 18.8 kDa
Figure 1. CTGrade GMP rh IL-10 (1 μg) was resolved with SDS-PAGE under non-reducing (NR) conditions and visualized by InstantBlue staining showing a single prominent band at 18.8 kDa.
Cell-based Proliferation Assay
Figure 2. The biological activity of CTGrade GMP rh IL-10 was determined in a cell proliferation assay using MC/9 mouse mast cells.
Lot-to-lot Consistency
Figure 3. CTGrade GMP rh IL-10 induces proliferation in MC/9 cells that is consistent between lots.
Bioactivity Comparison with Commercially-available GMP IL-10
Figure 4. Bioactivity comparison between CTGrade GMP rh IL-10 and commercially-available GMP IL-10.
CTGrade GMP rh IL-10 lyophilized at 1 mg/ml in 10 mM Sodium Phosphate, pH 7.5, 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 MC/9 cells. The ED50 is typically less than 5 ng/mL. The international units of CTGrade GMP rh IL-10 is approximately 5.4 x 103 IU/µg, which is calibrated against recombinant human interleukin 10 WHO International Standard (NIBSC code 93/722).
Quality
Carrier-free and no animal- or human-derived materials were used during manufacturing
*For research use or further manufacturing and in ex vivo cell therapy applications.
**Animal component-free to the tertiary level (no animal-origin components or sub-components are used in the product, raw materials, including packaging or the manufacturing process). Supporting documentation available upon request.
***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.
