Custom ancillary material solutions, from small scale production to full GMP manufacturing

 

Our Bioprocessing Contract Development and Manufacturing Services (BP CDMS) team is committed to delivering custom GMP ancillary and raw material solutions to support your cell therapy journey. We offer GMP-compliant production options tailored for bioprocessing applications, with rigorous testing and robust process capabilities to support downstream regulatory authorization and ensure product safety for ancillary and raw material use.

 

The custom BP GMP products are manufactured in our dedicated bioprocessing GMP suite, with capabilities designed in accordance with established guidelines for cell therapy/ATMPs in addition to our ISO 13485:2016 quality management system:

  • USP<1043>: Ancillary Materials for Cell, Gene, and Tissue Engineered Products
  • Ph. Eur. 5.2.12: Raw Materials of Biological Origin for the Production of Cell-Based and Gene Therapy Medicinal Products

 

 

Core capabilities:

Illustration displays core capabilities of BioLegend’s custom GMP lab, covering reagents, customization options, and regulatory support.

 

Customization options, at a glace:

Illustration displays core capabilities of BioLegend’s custom GMP lab, covering reagents, customization options, and regulatory support.

 

 

Project workflow: from concept to delivery and beyond:

 

We partner with you from initial development and full-scale manufacturing to post-production support.

Graphic showing a project workflow that goes from conceptualization to pre-GMP production to scale up production, and delivery of final product.

Partner with us!

Let us know how we can fulfill your bioprocessing needs here:

 

 

ProductsHere

Login / Register
Remember me
Forgot your password? Reset password?
Create an Account