Our GMP recombinant proteins are intended for use in expansion, polarization, and differentiation of cells for research and ex vivo cell processing applications.
Each lot of our GMP recombinant proteins undergoes extensive QC testing, including:
- Biological Activity Validation
- Purity Testing
- Concentration Check
- Endotoxin Testing (<0.1 EU/µg)
- Bioburden Testing
- Mycoplasma Testing
BioLegend GMP recombinant proteins are manufactured in a dedicated GMP facility and are compliant with our ISO 13485:2016-certified quality management system. Products 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. BioLegend GMP recombinant proteins and antibodies are not intended for therapeutic or diagnostic purposes.
Our processes include:
- Ensuring batch-to-batch consistency
- Documented procedures and employee training
- Equipment maintenance and monitoring records
- Materials traceability
- Lot-specific certificates of analysis
- QA review of released products