Process Development Capabilities

- Lonza Netherlands B.V. -

Lonza Netherlands aims to help accelerate technology development in the industry, mostly focused on upscaling and automation

Lonza Netherlands is involved in projects with international consortia from both academia as well as industry to bridge preclinical development to clinical manufacturing. Lonza Netherlands Process Development scientists address:

 Technology Transfer

  • Provide scientific and development consultancy during Technology Transfer from clients

 Upscaling & Automation

  • Have technologies in-house for Upscaling & Automation:
    • Multilayer cell stacks
    • Development to closed processing
    • WAVE
    • 3L, 50L & 200L Bioreactor systems for suspension cells and carrier culturing
    • Optimization culture processing, including carrier culture
    • 3-D culture processing with scaffold technology

 Quality Control Assay Development

  • Identity & Potency testing development
  • Stability Testing program development
  • Design matrix validation of safety testing for cellular products

 Manufacturing Development

  • Making GMP compliant manufacturing process out of academia
  • Design validation and re-validation programs of manufacturing process
  • Cryopreservation development
  • Comparability study program development

 

GMP Certification CMF Geleen

The Geleen Cell Manufacturing Facility was first GMP certified in 2012 by the Dutch authorities (IGZ).

Fact sheet

GMP Certification CMF Maastricht

Our Maastricht Cell Manufacturing Facility was first GMP certified in 2006 and has been successfully inspected by the Dutch Authorities (IGZ) on a regular basis thereafter.

Fact sheet