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Process Diagnostic

Understanding the reference process

The Process Diagnostic is used to optimize the technology transfer and to put together the development plan.

Its objective is to define the project and assess the current manufacturing and analytical processes with the aim of recommending improvements in order to prepare for the clinical study.

It is a document that MaSTherCell shares with the customer and includes:

  • A technology transfer plan
  • A development plan
  • A GMP preparation plan. 

The Process Diagnostic helps to:

  • Build the first steps of the collaboration
  • Show a long-term view of the various steps of the project
  • Execute seamless transitions from development to cGMP manufacturing
  • Streamline clinical manufacturing processes
  • Evaluate future work that needs to be done 
  • Position the cell therapy product for long-term success
  • Integrate analytical strategy in the development plan.  

Tech Transfer (non GMP)

Handling the process

  • Training runs
  • Raw material procurement
  • Equipment installation and qualification

Process Optimization

GMP and optimized process development

  • Streamlining
  • Closing/automation

  • Upscaling/outscaling

  • Appropriate clinical phase approach

  • Cost reduction

Analytical Development

  • Rationalization of sampling plan
  • Development of analytical methods
  • Process and product characterization (potency assay) validation
  • Product comparability throughout development

GMP Translation

Making the process cGMP compliant

  • GMP documentation
  • Engineering runs
  • Qualification runs
  • Aseptic Process Simulations

GMP Manufacturing

After the process development we can perform the cGMP manufacturing of your cell therapy.