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.

 

View all GMP cell culture and ancillary reagents.

 

Product specifications and manufacturing guidelines include:     

  • Animal component-free or chemically defined formulations
  • 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
  • Manufactured under ISO 5, 7, or 8 environment
  • Viral testing where applicable
  • 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

CD or XF Media Supplements

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

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Media Solutions

Ready-to-use and safe media for expansion of mesenchymal stem cells.

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Cryopreservation Solutions

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

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Cell Isolation Reagents

Chemically defined isolation reagents that also validate and characterize cell properties.

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Reproducibility challenges arise when ill-defined supplements, such as serum or serum derivatives like fetal bovine serum (FBS) or human AB serum, are employed for key cell culture and manipulation steps in the workflow. Media reagents that are chemically defined or free from animal-derived components can replace human serum for cell culturing, thereby avoiding safety risks and variability between product lots while ensuring product consistency.

 

Compared to human AB serum, CHEMICALLY DEFINED (CD) and XENO-FREE (X)F formulations:

  • Minimize risk SINCE components are fully defined
  • Are not affected by donor-specific characteristics such as gender, age, sex, and diet
  • Are consistent from one lot to the next
  • Are customizable

Don't see your product in our catalog?

 

We partner with our customers to deliver customized pre-GMP and GMP ancillary material solutions for cell therapy manufacturing.

 

Request your custom solutions

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