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
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