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

 

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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

 

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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
  • Serum free hybridomas are tested negative for presence of human and murine viruses by qPCR method
  • Ultra-low endotoxin test via LAL method
  • Mycoplasma testing via qPCR method
  • Sterility/bioburden testing
  • Functional tests

 

*wherever applicable

 

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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