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Cell-Vive™ GMP Portfolio

 

BioLegend’s Cell-Vive™ GMP portfolio of ancillary products is specifically designed and manufactured for ex vivo cell processing and downstream manufacturing. Manufactured under controlled, traceable, and consistent workflows, these products are supported by strict documentation and released with independent quality oversight, ensuring quality in the final cell product.

 

Cell-Vive™ GMP products are animal component-free and manufactured in accordance to USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products and Ph. Eur. Chapter 5.2.12 guidelines in a dedicated ISO 13485:2016 certified GMP facility. Cell-Vive™ cell culture products are released and monitored through independent QA oversight.

 

Product specifications and manufacturing guidelines include:     

  • Animal component-free or xeno-free manufacturing
  • Batch-to-batch consistency
  • Vendor qualification
  • Raw material traceability and documentation
  • Documented procedures and employee training
  • For research use only and suitable for ex vivo cell processing
  • Equipment maintenance and monitoring records
  • Lot-specific Certificate of Analysis (CoA)
  • Quality audits per ISO 13485:2016
  • QA review of released products

Find complete GMP manufacturing quality and regulatory statements here.

Cell-Vive™ GMP Cell Culture & Ancillary Reagents

For cell culture applications, we offer serum-free, chemically defined reagents for optimal cell expansion and separation.

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Cell-Vive™ GMP Recombinant Proteins

Our cytokines and growth factors are bioassay-validated for use in research and ex vivo cell processing applications.

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Cell-Vive™ GMP Ultra-LEAF™ Functional Antibodies

These functional antibodies are potent for cell activation, expansion, and functional in vitro or in vivo assays.

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