BioLegend’s Cell-Vive™ GMP portfolio of 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 in a dedicated GMP facility compliant with ISO 13485:2016 at San Diego, California, USA. Cell-Vive™ GMP portfolio of products is supported by lot-specific Certificate of Analysis and is tested for consistency and safety required for ex vivo cell processing and downstream manufacturing.
Cell-Vive™ GMP Manufacturing Standards and Guidelines
- All of our GMP products
- Are manufactured in an ISO 13485:2016 certified GMP manufacturing facility.
- Adhere to strict manufacturing guidelines.
- USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products.
- Are manufactured according to our chemically-defined or xeno-free and animal component-free manufacturing definitions. For details, please click here.
- Are supported by standard product documentation.
- Technical Data Sheet (TDS)
- Lot-specific Certificate of Analysis (CoA)
- Certificate of Origin (CoO)
- TSE/BSE Documentation
Consistency
Consistent batch-to-batch product performance is necessary to develop standardized, controlled, and repeatable cell manufacturing workflow and processes. All Cell-Vive™ GMP cell culture products are manufactured with the highest quality raw materials, supplied by qualified vendors and supported by strict traceable documentation.
- Raw material management and control
- Vendor qualification and monitoring
- Raw material traceability and documentation
- Environmental control and monitoring
- Documented procedures and employee training
- Equipment maintenance and monitoring record
- Strict quality-controlled documentation and SOPs for manufacturing procedures
- Quality audits per ISO 13485:2016
- QA review of released products manufactured in an ISO 13485:2016 certified GMP manufacturing suite
- CoA and CoO available
Certificate of Analysis Specifications
All product lines under Cell-Vive™ GMP portfolio are supported with lot-specific CoAs detailing analytical characterization and tests performed to ensure product identity, safety, purity, sterility, and stability.
Cell-Vive™ GMP Cell Culture and Ancillary Reagents CoA
- Tests
- Endotoxin test via LAL method
- Mycoplasma testing via qPCR method
- Sterility/bioburden testing following USP <71> guidelines
- Osmolality
- pH
- Functional assay
Cell-Vive™ GMP Recombinant Proteins CoA
- Tests
- Endotoxin test via LAL method
- Mycoplasma testing via qPCR method
- Sterility/bioburden testing
- Host cell protein by ELISA*
- Host cell DNA by qPCR*
- Analytical characterization
- Purity by SDS-PAGE
- N-terminal sequencing*
- Bioactivity in IU/mL*
Cell-Vive™ GMP Ultra-LEAF™ Functional Antibodies CoA
- Tests
- Ultra-low endotoxin test via LAL method
- Mycoplasma testing via qPCR method
- Sterility/bioburden testing
- Functional tests
*wherever applicable
Regulatory Statements and Guidelines
- Manufactured in an ISO 13485:2016 certified GMP manufacturing facility
- Tested in accordance with standard guidelines
- USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
- GMP Operations are MDSAP certified and are monitored through independent QA oversight
Follow Us