説明
Interleukin-1 alpha (IL-1α) is a non-secreted pro-inflammatory cytokine produced by a variety of cells, including monocytes, tissue macrophages, keratinocytes, and other epithelial cells. It exerts metabolic, physiological, and hematopoietic activities, and plays a central role in the regulation of immune responses. IL-1α is encoded by the IL1A gene and signals through two receptors, IL-1RI and IL-1RII, both of which are shared with IL-1β; the two cytokines therefore exhibit similar biological properties. These cytokines display a broad range of activities, including induction of B cell maturation and proliferation and promotion of fibroblast proliferation and type I procollagen synthesis.
Product Properties
|
Item |
Specification |
|
Synonyms |
Interleukin-1 alpha, IL-1α, BAF, IL-1F1, LAF, LEM, preinterleukin 1 alpha, pro-interleukin-1-alpha |
|
Species |
Human |
|
Expressed Sequence |
Ser 113 - Ala 271 |
|
Accession |
P01583 |
|
Tag |
No Tag |
|
Expression System |
E. coli |
|
Molecular Weight |
Approximately 17.5 kDa. |
|
Purity |
> 95% as determined by SDS-PAGE and HPLC. |
|
Endotoxin |
< 0.01 EU per μg by the LAL method. |
|
Formulation |
0.22 μm filtered concentrated solution in PBS. |
|
Appearance |
Lyophilized Powder |
|
Biological Activity |
The ED50 as determined by the dose-dependent stimulation of murine D10S cells is ≤ 10 pg/mL. |
|
Reconstitution Method |
It is recommended to reconstitute the protein in sterile PBS to a concentration of 0.1-1.0 mg/mL. Avoid repeated freeze-thaw cycles whenever possible. |
Features
Product Advantages
- High purity: >95%, preventing immune reactions caused by residual host cell protein (HCP) or DNA.
- Ultra-low endotoxin: <10 EU/mg, minimizing the risk of fever or inflammation.
- Batch-to-batch consistency: ensuring stability and reproducibility in cell culture.
- Regulatory compliance: meeting regulatory requirements for cell therapy products and supporting IND submissions.
- Animal-origin-free: free of animal viruses, pathogenic agents, and adventitious agent contamination, ensuring high safety.
Regulatory Guideline Compliance
The manufacturing and quality control of GMP-grade proteins comply with the following systems and processes:
1. Complies with the General Principles of Volume III of the Pharmacopoeia of the People's Republic of China (2020 Edition): Quality Control of Raw Materials and Excipients for Biological Product Manufacturing.
2. Complies with USP Chapter <92> Growth Factors and Cytokines Used in Cell Therapy Manufacturing.
3. Complies with Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products.
Quality Management System
1. GMP proteins are manufactured, tested, and released under an ISO 13485:2016-certified quality management system, ensuring batch-to-batch consistency and material traceability.
2. Supplied with an approved Certificate of Analysis (COA).
3. Animal-origin-free materials and production environment.
4. Manufacturing site for pharmaceutical raw materials and excipients.
5. On-site and remote audits supported.
Product Safety Testing System
• Endotoxin: <10 EU/mg
• Residual host DNA: < 20 ng/mg
• Residual host cell protein: < 0.5 ng/μg
• Sterility test: Negative
• Mycoplasma test: Negative
• Adventitious virus test: Negative
Applications
SDS-PAGE
Figure 1. Human IL-1 alpha GMP Protein on SDS-PAGE under reduced condition. The purity is greater than 95%.
SEC-HPLC
Figure 2. The purity of Human IL-1 alpha GMP Protein is greater than 95% as determined by SEC-HPLC.
Cell Based Assay
Figure 3. The ED50 as determined by the dose-dependent stimulation of murine D10S cells is ≤ 10 pg/mL.
Storage
Store at -25 to -15°C, valid for 3 years. After reconstitution, store at -85 to -65°C, valid for 3 months.
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