Pre-GMP facility: our offer

Mission statement: The Pre-GMP Facility bridges research and GMP manufacturing, helping biotech companies, researchers, and healthcare innovators develop, optimise, and de-risk ATMP processes for safe translation towards the clinic.

Flow chart showing Translation of Advanced Therapy Medicinal Products (ATMPs) from the research laboratory to clinical application.
Translation of Advanced Therapy Medicinal Products (ATMPs) from the research laboratory to clinical application. Photo: Lara Sweetapple

We support with:

  • Production of ATMPs including mRNA–LNPs, viral vectors, and engineered immune cells 
  • Training in a GMP-environment 
  • Process development and optimization 
  • Scale-up and validation 
  • Technology transfer 

Is Pre-GMP right for your project? 

A research protocol is not necessarily suitable for clinical manufacturing. The Pre-GMP Facility supports the development of robust, reproducible processes and workflows that can be evaluated and adapted for subsequent GMP manufacturing.  

The Pre-GMP Facility can support projects that:

  • Require translation of a research protocol into a reproducible manufacturing process. 
  • Need development, optimisation, or validation of manufacturing processes. 
  • Require SOPs and workflows suitable for subsequent GMP transfer. 
  • Need access to specialised ATMP expertise or infrastructure. 
  • Involve cellular, viral vector, mRNA- or LNP-based products requiring production or process development.