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Shenandoah CTGrade GMP rh IFN-alpha 2A 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
≥ 98% purity
Size: 50 µg, 100 µg, and 1 mg. Custom sizes and packaging available on request.
Recombinant human IFN-alpha 2A, also known as leukocyte interferon, is a type I interferon with potent antiviral and immunomodulatory properties. It is widely used as a therapeutic agent for viral infections, hematologic malignancies, and solid tumors.
Activates the JAK-STAT signaling pathway, leading to antiviral defense-inhibition of viral replication and enhancement of cellular resistance to infection
Suppresses tumor cell growth and induction of apoptosis through antiproliferative activity
Upregulates class I MHC, activates NK cells and cytotoxic T lymphocytes, and modulates B-cell antibody production
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.
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 19.4 kDa
Figure 1. CTGrade GMP rh IFN-alpha 2A (1 μg) was resolved with SDS-PAGE under non-reducing (NR) and reducing (R) conditions and visualized by Instant Blue staining showing a single prominent band at 19.4 kDa.
Cell-based Proliferation Assay
Figure 2. The biological activity of CTGrade GMP rh IFN-alpha 2A was determined in a cell proliferation assay using TF-1 cells.
Bioactivity Comparison Between CTGrade GMP rh IFN alpha-2A and Commercially-available rh IFN alpha-2A
Figure 3. Bioactivity comparison between CTGrade GMP rh IFN-alpha 2A and commercially-available rh IFN-alpha 2A.
Technical Specifications
Formulation
CTGrade GMP rh IFN-alpha 2A is lyophilized from a 0.2 μm filtered solution containing 10 mM Sodium Phosphate and 140 mM Sodium Chloride, pH 7.4.
Protein Purity
≥ 98% 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 induction of cytotoxicity of TF-1 cells by rh IFN-alpha 2A cells. The ED50 is typically less than 0.3 ng/mL.
Quality
Carrier-free and no animal- or human-derived materials were used during manufacturing
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
