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.

 

 

Data

 

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

 

GMP Ultra-LEAF™ Purified anti-GDNF Antibody data

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

Features:
 

  • Cell-Vive™ T-NK Xeno-Free Serum Substitute is an optimally formulated, defined media reagent, intended to replace human AB serum, providing researchers with more control over culture conditions.
  • Serum Substitute is GMP manufactured and engineered to culture and expand immune cells (T cells, NK cells). See Data
  • Replaces human serum, thereby reducing potential safety risks, lot-to-lot inconsistencies and supply issues associated with human serum.

 

Each lot of Cell-Vive™ T-NK Xeno-Free Serum Substitute undergoes extensive QC testing, including:
 

  • Endotoxin Testing (<0.1 EU/mL)
  • pH Testing
  • Osmolality Testing
  • Mycoplasma Testing
  • Sterility Testing
  • T Cell Function Validation

 

Check out Dr. Vanda Lopes’ (BioLegend) presentation “A Novel Serum Substitute for Optimal Culture of T & NK Cells” from the ISCT 2021 Virtual Annual Meeting.

 

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.

 

Cell-Vive™ T-NK Xeno-Free Serum Substitute, GMP, supports greater cell expansion of naïve T cells, generating a higher number per million of PBMCs plated by day 11.

 

Procedure: PBMC-derived T cell culture was activated with anti-human CD3, anti-human CD28, and 200 IU/mL of recombinant human IL-2 using IMDM as basal media.

 

Cell-Vive™ T-NK Xeno-Free Serum Substitute, GMP, supports NK cell expansion with high cell viability by day 14.

 

Procedure: PBMC-derived NK cells were cultured using K-562 feeder cells (2:1) and 1000 IU/mL of recombinant human IL-2 using IMDM as basal media.


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.

 

 

Cell bioprocessing workflow

Our custom capabilities Include:

 

  • GMP recombinant protein and antibody manufacturing
  • Bulk GMP recombinant proteins and antibodies
  • Recombinant antibodies (partial or full length, species and isotype switching)
  • Custom antibody cocktails in solution or lyophilized
  • Custom antibody conjugations (fluorophores, oligonucleotides, enzymes)
  • Custom immunoassays

Why consider BioLegend for your custom solutions?

 

  • Lot sizes and yield to fit your demand (from 1 mg to 1 g)
  • Exclusive US-based development and manufacturing
  • ISO 13485:2016 and MDSAP-certified quality management system
  • Lot-to-lot consistency, fast delivery, and affordability

 

FAQs

What is a GMP recombinant protein or antibody?

GMP stands for Good Manufacturing Practice. GMP recombinant proteins and antibodies are manufactured under specific guidelines to ensure product quality and consistency. BioLegend GMP recombinant proteins and antibodies are produced with extensive quality documentation and full material traceability under independent QA oversight.

What is the difference between BioLegend standard RUO and GMP recombinant proteins and antibodies?

BioLegend GMP recombinant proteins and antibodies perform at the same high level as our standard RUO products. No difference in performance should be expected between BioLegend standard RUO and GMP versions. The major difference is the completeness of documentation, material traceability, and independent QA oversight. Additional quality testing may be done depending on the product.

Are BioLegend GMP recombinant proteins or antibodies animal-free?

BioLegend GMP recombinant proteins and antibodies are not animal-free. In all cases where possible, BioLegend attempts to minimize the use of animal components in the manufacturing process. For specific details regarding the use of animal components in the manufacturing process of particular products, please inquire with our technical services team here.

What is the regulatory status and standards for BioLegend GMP recombinant proteins and antibodies?

BioLegend GMP recombinant proteins and antibodies are manufactured in compliance with ISO 13485:2016 and MDSAP. BioLegend GMP recombinant proteins and 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.

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