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:

Comparison of RUO Recombinant Proteins vs Cell-Vive™ GMP Recombinant Proteins

Cell-Vive GMP recombinant proteins are rigorously tested for lot-to-lot consistency, purity, and functional potency using cell-based bioassays, and feature comprehensive safety testing and analytical specifications. 

Consistent lot-to-lot bioactive performance is one of the critical challenges to scale-up ex vivo processing workflows. At BioLegend, we test our GMP recombinants to ensure comparable functional performance when our customers switch from one lot to the next and maintain consistency.

Our GMP recombinant proteins are also tested for stability at different temperatures and time intervals. Our tests demonstrate no loss of functional activity after multiple freeze-thaw cycles and incubation at 37°C for a week.

High degree of purity is essential so that only minimal impurities are introduced into ex vivo cell processing workflows. At BioLegend, our GMP recombinant proteins are purified to ≥95% purity as analyzed via SDS-PAGE.

SDS-PAGE gel showing GMP recombinant human EGF, DTT-reduced (lane 1), protein molecular weight markers (lanes 2 and 4), and GMP human IL-13, DTT-reduced (lane 5). Lane 3 is empty.

Functional activity demonstrates the potency of a biologically active substance. Our GMP recombinant proteins are tested for functional activity using cell-based assays against a WHO standard, when available, or a master lot. Read how we use reference standards to calculate the functional activity of our GMP recombinant proteins using International Units Measurements.