GMP Human M-CSF Protein

• 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.

GMP Human M-CSF Protein (GMP-MCFH24) is expressed from human 293 cells (HEK293). It contains AA Glu 33 - Arg 255 (Accession # P09603-1).

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.