Current Good Manufacturing Practices (CGMP) is a system for ensuring that products are consistently produced and controlled according to quality requirements. For those seeking products for research or ex vivo cell bioprocessing, our GMP recombinant proteins and antibodies are produced with quality documentation and full traceability, under independent QA oversight.

Recombinant Proteins

Our GMP recombinant proteins are intended for use in expansion, polarization, and differentiation of cells for research and ex vivo cell processing applications.

Each lot of our GMP recombinant proteins undergoes extensive QC testing, including:

• Biological Activity Validation
• Purity Testing
• Concentration Check
• Endotoxin Testing (<0.1 EU/µg)
• Bioburden Testing
• Mycoplasma Testing

BioLegend GMP recombinant proteins are manufactured in a dedicated GMP facility and are compliant with our ISO 13485:2016 and MDSAP-certified quality management system. 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. BioLegend GMP recombinant proteins and antibodies are not intended for therapeutic or diagnostic purposes.

Our processes include:

• Ensuring batch-to-batch consistency
• Documented procedures and employee training
• Equipment maintenance and monitoring records
• Materials traceability
• Lot-specific certificates of analysis
• QA review of released products

Biofunctional Antibodies

Biofunctional antibodies can mimic or interrupt the natural biological effects associated with ligand-receptor interaction. Or, they can directly affect a target cell or molecule. Because of these features, biofunctional antibodies are ideal tools for functional in vitro or in vivo assays. To meet your research or cell processing needs, explore our expanding line of GMP biofunctional antibodies - manufactured in a dedicated GMP facility and compliant with ISO 13485:2016 and MDSAP.

Our operating procedures include:

• Batch-to-batch consistency
• Material traceability
• Documented procedures
• Documented employee training
• Equipment maintenance and monitoring records
• Lot-specific certificates of analysis
• Quality audits per ISO 13485:2016 and MDSAP
• QA review of released products

GMP Ultra-LEAF™ Purified anti-human CD3 SF Antibody

Our GMP Ultra-LEAF™ Purified anti-human CD3 SF Antibody (clone OKT3) is a potent activator of T cells, intended for use in the expansion of T cells for cell bioprocessing or other research applications. This biofunctional antibody is GMP manufactured under serum-free conditions, including serum-free hybridoma cell culture, without additional animal or human-derived materials. Each lot is tested for biofunctional activity measured by T cell expansion.

As our representative data show, our GMP serum-free OKT3 monoclonal antibody, in combination with anti-CD28, boasts similar bioactivity compared to our non-GMP product, thus ensuring it will be a potent tool to support your cell bioprocessing needs.

PBMC derived T cells were activated in the presence of Ultra-LEAF™ anti-human CD28 antibody (Cat. No. 302933) alone, or combined with Ultra-LEAF™ anti-human CD3 (Cat. No. 317326) or GMP Ultra-LEAF™ anti-human CD3 SF (Cat. No. 317354) for a period of 4 days. Activation was done via plate coating, with 1 μg/mL of each antibody. Cells were cultured for a total of 10 days, and viable cell number was determined.

GMP Ultra-LEAF™ Purified anti-GDNF Antibody

Glial cell-derived neurotrophic factor (GDNF) is a member of the TGF-β superfamily that signals through GDNF family receptor α-1 (GFRα1) to promote the development, differentiation, and survival of dopaminergic neurons. Because of its neuroprotective nature, GDNF is currently under investigation as a promising therapeutic for the treatment of Parkinson’s disease. We offer potent tools to study GDNF properties. Our GMP Ultra-LEAF™ Purified anti-GDNF antibody (purple squares, clone A16099G, Cat. No. 670905) inhibits the binding of recombinant human GFRα1 (black circles, Cat. No. 788102) to immobilized recombinant human GDNF (Cat. No. 760402) in a dose-dependent manner, while the isotype control (grey triangles, Cat. No. 401215) does not have the effect. This antibody neutralizes the binding of GFRα1 protein to GDNF, allowing researchers to examine neuronal growth and progression in disease and treatment models.

Cell Culture Reagents

At BioLegend, we understand the critical steps involved in advancing your research from the lab to therapeutics. Our GMP Cell Culture Reagents drive cell expansion and enrichment to meet your cell processing needs. Our expanding line of GMP tools are manufactured under strict regulatory guidelines and are available at affordable prices. BioLegend is ISO 13485:2016 and MDSAP certified, and our GMP facility is ISO 13485:2016 and MDSAP certified.

Cell-Vive™ T-NK Xeno-Free Serum Substitute, GMP (Cat. No. 420502)

For Research or Further Cell Manufacturing Use Only

Browse through our data below for the Cell-Vive™ T-NK Xeno-Free Serum Substitute featured in Dr. Lopes' talk. Read our article to learn how Cell-Vive™️ drives T and NK Cell Expansion.

Custom Capabilities

Emerging therapies involving stem cells, CAR-T, CAR-NK, and others, rely on consistent, quality products for ex vivo manufacturing and quality control. These reagents are crucial for product development and cell bioprocessing applications. We offer BioLegend GMP recombinant proteins and antibodies as custom products for many of the steps of the cell bioprocessing workflow.