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Cell-Vive™ GMP Recombinant Proteins

 

BioLegend Cell-Vive™ GMP recombinant proteins 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 ISO 13485:2016 certified GMP facility.

 

Find complete GMP manufacturing quality and regulatory statements here.

 

Our GMP recombinant proteins are ideal for use in expansion, polarization, and differentiation of cells for research and ex vivo cell processing applications. BioLegend GMP recombinant proteins are also free of BSA or other equivalent carrier proteins, thus eliminating the risk of introducing nonrelated or undesired effects on experiments.

 

View all GMP recombinant proteins.

Product specifications and manufacturing guidelines include:

  • Low endotoxin level (≤0.1 EU/µg)
  • Purity (≥ 95% or higher)
  • Sterility testing
  • Mycoplasma testing
  • Batch-to-batch consistency
  • Vendor qualification
  • Source information
  • N-terminal sequencing up to first 10 amino acids
  • Host cell protein content
  • Functional activity in IU against a master lot
  • Raw material traceability and documentation
  • Documented procedures and employee training
  • Equipment maintenance and monitoring records
  • Lot-specific Certificate 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

Contact our sales team for help with custom products or bulk requests.

 

For cell research to have translational potential, the importance of consistent performance and quality in raw materials cannot be overstated. The highly potent bioactivity of our GMP-grade cytokines, such as IL-2, IL-7, IL-15, and IL-21, is verified for each product lot, ensuring consistent quality. See how we use reference standards to calculate the functional activity of our GMP recombinant proteins using International Units Measurements.

IL-2, IL-7, and IL-15 are among critical growth factors for T cells, playing pivotal roles in T cell-based cancer immunotherapy. Our representative data show that GMP recombinant human IL-2 (left) and IL-7 (center) induce dose-dependent proliferation of cells. Lot-to-lot comparisons, as shown for GMP recombinant human IL-15 (right), demonstrate consistent potency while meeting GMP requirements needed for downstream cell manufacturing.

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