現行医薬品適正製造基準(Current Good Manufacturing Practices : CGMP)は、製品が品質要件に従って管理され、一貫して製造されることを保証するための制度です。当社のGMPグレード製品(リコンビナントタンパク質および抗体)は独立した品質管理部門の監視の下で、定められた文書を管理し、完全なトレーサビリティを確保して製造しています。したがって、研究用あるいはex vivoでの細胞プロセシング用製品をお探しの方に最適です。

 

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

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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