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
  • Stability 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-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

 


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 ex vivo 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 certified, and our GMP facility is ISO 13485:2016 and MDSAP certified.

 

Cell-Vive™ T-NK Xeno-Free Serum Substitute, GMP

For Ex Vivo Cell Processing

 

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. If you're interested in learning more or receiving our Serum Substitute product as soon as it is available, contact your local field representative.

 

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-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. 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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