GMP Human IL-10 Protein

• Wide-ranging functions: Plays a key regulatory role in suppressing excessive pro-inflammatory responses and cytokine release syndrome (CRS) in immune cell culture, while promoting immune tolerance and regulating anti-inflammatory phenotypes in TIL, CAR-T and regulatory T cell (Treg) cultures.
• High Performance: Exhibits superior biological activity, making it the preferred choice for numerous pharmaceutical enterprises in preclinical and clinical-stage cell therapy and immunomodulatory drug development.
• Comprehensive Safety Assurance: ECACC-compliant HEK293 host cell origin and comprehensive testing (28 items), animal origin-free (AOF) production process, with stringent final product quality control and release specifications to support clinical-grade applications.
• Lot-to-Lot Consistency: Achieved through a stable cell line and robust process, ensuring reliable performance from research to clinical manufacturing.

• Quality Assurance: Global QMS with comprehensive and stringent QC release criteria.
• End-to-End GMP Compliance: Full manufacturing and QC under a cGMP system.
• Comprehensive Control of Adventitious Agents: Stringent biosafety from cell banks to final release.
• Comprehensive Regulatory Support: Includes RSF and DMF to meet global requirements.
• Resilient Supply Chain: Intelligent modular facilities ensure a stable global supply.
• Professional Support: Extensive manufacturing and application expertise to accelerate development.

Ser-Pro-Gly-Gln-Gly-Thr-Gln-Ser-Glu-Asn-Ser-Cys-Thr-His-Phe-Pro
(Routinely tested)

Less than 10 EU/mg, tested by the LAL method in compliance with USP <85> and Ph. Eur. 2.6.14.

<0.5 ng/µg of protein tested by ELISA.

<0.02 ng/μg of protein tested by qPCR.

Sterility testing was performed using the membrane filtration method in compliance with USP <71> and Ph. Eur. 2.6.1.

Negative

>95% as determined by SDS-PAGE.

Lyophilized from 0.22 μm filtered solution in PBS, pH7.4 with protectants.

Contact us for customized product form or formulation.

2R (13 mm neck finish)

This product is supplied and shipped on blue ice.

Upon receipt, store it immediately at -20°C or lower for long term storage.

Please avoid repeated freeze-thaw cycles.

• -20°C to -70°C for 5 years in lyophilized state;
• -70°C for 12 months under sterile conditions after reconstitution.