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Cell-Vive™ GMP Cell Culture & Ancillary Reagents

 

BioLegend Cell-Vive™ GMP Cell Culture 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.

 

Product specifications and manufacturing guidelines include:     

  • Low endotoxin level (<1 EU/mL)
  • Mycoplasma, microbial, and fungal growth testing
  • Batch-to-batch consistency
  • Vendor qualification
  • Raw material traceability and documentation
  • Documented procedures and employee training
  • Equipment maintenance and monitoring records
  • Lot-specific Certificates of Analysis (CoA)
  • Quality audits per ISO 13485:2016
  • Quality Assurance review of released products
  • Drug Master File (DMF) support
  • For research use only and suitable for ex vivo cell processing

Serum-Free Media Supplements

Serum-free and chemically defined media supplements to support proliferation and expansion of immune cells.

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Cryopreservation Media

Serum-free and chemically defined formulation to preserve cultured and processed immune cells.

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Cell Isolation Reagents

Chemically defined, and human and animal component-free, isolation reagents to validate cell properties.

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