BioLegend Cell-Vive™ GMP recombinant proteins are manufactured and tested in accordance with USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products and Ph. Eur. Chapter 5.2.12 in a dedicated ISO 13485:2016 certified GMP facility.

Find complete GMP manufacturing quality and regulatory statements here.

Our GMP recombinant proteins are ideal for use in expansion, polarization, and differentiation of cells for research and ex vivo cell processing applications. BioLegend GMP recombinant proteins are also free of BSA or other equivalent carrier proteins, thus eliminating the risk of introducing nonrelated or undesired effects on experiments.

View all GMP recombinant proteins.

• Low endotoxin level (<0.1 EU/µg)
• Purity (≥ 95% or higher)
• Sterility testing following USP
• Mycoplasma testing
• Batch-to-batch consistency
• Vendor qualification
• Source information
• N-terminal sequencing up to first 10 amino acids
• Host cell protein content

• Functional activity in IU against a master lot
• Raw material traceability and documentation
• Documented procedures and employee training
• Equipment maintenance and monitoring records
• Lot-specific Certificate of Analysis (CoA)
• Quality audits per ISO 13485:2016
• Quality Assurance review of released products
• Drug Master File (DMF) support
• For research use only and suitable for ex vivo cell processing