Human IL-10 Protein, premium grade
Features and Advantages
1. Seamless Transition from Preclinical to Clinical: Same cell clone, process, and QC as GMP products.
2. Enhanced Production Standards: AOF raw materials, pharma-grade excipients, Grade B+A (ISO 5) environment.
3. Comprehensive Quality Control: Additional strict testing for process impurities, sterility, and mycoplasma.
4. Cost-Effective Solution: GMP-comparable quality at an economical price for early development.
5. Risk Mitigation: Enhanced safety through rigorous impurity control and comprehensive testing.
Synonym
CSIF, IL-10, IL10A, TGIF, B-TCGF, GVHDS, MGC126450, MGC126451, RP11-262N9.1, Interleukin-10
Source
Human IL-10, premium grade (IL0-H5219) is expressed from human 293 cells (HEK293). It contains AA Ser 19 - Asn 178 (Accession # P22301.1).
Predicted N-terminus: Ser 19
It is produced under our rigorous quality control system that incorporates a comprehensive set of tests including sterility and endotoxin tests. Product performance is carefully validated and tested for compatibility for cell culture use or any other applications in the early preclinical stage.
GMP-L10H25 is the GMP version of this IL0-H5219. These two proteins display indistinguishable performance profiles, thereby ensuring a seamless transition for end users from early preclinical stage to later clinical phases.
Molecular Characterization
This protein carries no "tag".
The protein has a calculated MW of 18.6 kDa. The protein migrates as 17 kDa±3 kDa when calibrated against Star Ribbon Pre-stained Protein Marker under reducing (R) condition (SDS-PAGE) due to glycosylation.
Endotoxin
Less than 0.01 EU per μg by the LAL method / rFC method.
Host Cell Protein
<0.5 ng/µg of protein tested by ELISA.
Host Cell DNA
<0.02 ng/μg of protein tested by qPCR.
Sterility
Negative
Mycoplasma
Negative
Purity
>95% as determined by SDS-PAGE.
>90% as determined by SEC-MALS.
Formulation
Lyophilized from 0.22 μm filtered solution in PBS, pH7.4 with trehalose as protectant.
Contact us for customized product form or formulation.
Reconstitution
Please see Certificate of Analysis for specific instructions.
For best performance, we strongly recommend you to follow the reconstitution protocol provided in the CoA.
Storage
For long term storage, the product should be stored at lyophilized state at -20°C or lower.
Please avoid repeated freeze-thaw cycles.
This product is stable after storage at:
-20°C to -70°C for 24 months in lyophilized state;
-70°C for 3 months under sterile conditions after reconstitution.
Background
Interleukin-10 (IL-10) is also known as human cytokine synthesis inhibitory factor (CSIF), is an anti-inflammatory cytokine. IL-10 is an immunosuppressive cytokine produced by a variety of mammalian cell types including macrophages, monocytes, T cells, B cells and keratinocytes. Mature human IL-10 shares 72% - 86% amino acid sequence identity with bovine, canine, equine, feline, mouse, ovine, porcine, and rat IL-10. Whereas human IL-10 is active on mouse cells, mouse IL-10 does not act on human cells. IL-10 is capable of inhibiting synthesis of pro-inflammatory cytokines such as IFN-γ, IL-2, IL-3, TNFα and GM-CSF made by cells such as macrophages and regulatory T-cells. It also displays a potent ability to suppress the antigen-presentation capacity of antigen presenting cells. However, it is also stimulatory towards certain T cells and mast cells and stimulates B cell maturation and antibody production. Knockout studies suggested the function of Interleukin-10 / IL-10 as an essential immunoregulator in the intestinal tract. Patients with Crohn's disease react favorably towards treatment with bacteria producing recombinant interleukin-10, showing the importance of interleukin-10 for counteracting excessive immunity in the human body.
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