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Cell-Vive™ GMP Portfolio Manufacturing Standards
and Quality Guidelines

 

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.

 

Two photos side-by-side with left showing researcher fully attired working in GMP lab and right showing automated bottling equipment.

 

Our GMP bioprocessing Quality Management System (QMS)

 

Our GMP products are manufactured, tested, and released under an ISO 13485:2016-certified quality management system. Our expanded GMP facility suite is MDSAP certified. Our QMS follows a two-tier structure: 

  • Tier 1: Fulfill ISO 13485:2016 for RUO (Research Use Only) products 
  • Tier 2: Fulfill ISO 13485:2016 and MDSAP applicable requirements for products manufactured in the designated GMP suite

Processes to ensure product consistency and supply chain continuity:

  • Consistent lot-to-lot product performance is necessary to develop standardized, controlled, and repeatable cell manufacturing workflows 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.

 

 

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

 

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 by LAL method
    • Mycoplasma testing by qPCR method
    • Sterility/bioburden testing by microbial culture
    • Osmolality and pH
    • Functional assay 
    • Comprehensive h-impact viral testing by PCR for select products

 

Cell-Vive™ GMP Recombinant Proteins CoA

  • Tests
    • Endotoxin test by LAL method
    • Mycoplasma testing by qPCR 
    • Sterility/bioburden testing by microbial culture
    • Host cell protein by ELISA
    • Host cell DNA by qPCR
    • Purity by SDS-PAGE
    • N-terminal sequencing up to 10 amino acids
    • Functional activity

 

Cell-Vive™ GMP Ultra-LEAF™ Serum-Free Antibodies CoA 

  • Tests
    • Endotoxin test by LAL method
    • Mycoplasma testing by qPCR 
    • Sterility/bioburden testing by cell culture/PCR
    • Functional testing

 

Cell-Vive™ GMP Cell Activation and Expansion Tools CoA

  • Tests
    • Endotoxin test by LAL method
    • Sterility/bioburden testing by microbial culture
    • Antibody leakage test by ELISA
    • Particle concentration by cell counter
    • Functional testing
 

Cell-Vive™ GMP Cell Isolation and Selection Tools CoA

  • Tests
    • Endotoxin test by LAL method
    • Mycoplasma testing by qPCR 
    • Sterility/bioburden testing by microbial culture
    • Capacity by colorimetric binding assay
    • Functional testing
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