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

Features

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

Figures

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.