BioLegend Cell-Vive™ GMP Ultra-LEAF™ antibodies 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.

Find complete GMP manufacturing quality and regulatory statements here.

Product specifications and manufacturing guidelines include:

Our CD3 and CD28 antibodies are optimized for T cell activation and expansion in ex vivo cell culture applications. They are offered as Ultra-Low Endotoxin, Azide-free (Ultra-LEAF™) antibody formulation to facilitate in vivo as well as in vitro experiments. We manufacture monoclonal antibodies GMP Ultra-LEAF™ Purified anti-human CD3 SF Antibody (clone OKT3) and GMP Ultra-LEAF™ Purified anti-human CD28 SF Antibody (clones S20013F and CD28.2) under serum-free (SF) animal component-free conditions. This feature is important because animal-derived components, such as fetal bovine serum (FBS), are heterogeneous in nature, which negatively impacts lot-to-lot product consistency. Our SF CD3 and CD28 antibodies remove this risk and brings consistency to the T cell processing workflow.

CD34 markers are expressed on immature hematopoietic stem/progenitor cells (HSPCs) and downregulated as early stem cells differentiate into mature cells. This expression pattern of CD34 suggests that it plays a significant role in early hematopoiesis. Cell-Vive™ GMP Ultra-LEAF™ Purified anti-human CD34 SF Antibody is suitable for research and further ex vivo cell processing, making it ideal to identify and isolate HSPCs as well as for cell analysis to gauge cell recovery and functionality.

Our GMP Ultra-LEAF™ Purified anti-human HLA-A,B,C SF Antibody is also ideal for use in research and further ex vivo bioprocessing, HLA I molecules are part of MHC class I system that present foreign-derived peptides to cytotoxic CD8⁺ T cells, thus playing an important role in cell-mediated immune responses and tumor surveillance.

In addition, we are growing our portfolio of biotinylated antibodies. Our GMP Ultra-LEAF™ Biotin anti-human CD3 SF Antibody and GMP Ultra-LEAF™ Biotin anti-human CD28 SF Antibody can serve as probes to facilitate T cell research and/or T cell separation.

We also offer GMP Ultra-LEAF™ Biotin anti-human HLA-A,B,C SF Antibody that was designed for multiple functions: for cell analysis using flow cytometry, immunoprecipitation, Western blotting, immunohistochemical staining of fixed tissue sections, inhibition of NK cell-mediated lysis, as well as for blocking and activation.