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GMP Simulation Facility
The GMP simulation facility provides the translation of new innovations towards GMP production for clinical application. It focusses on efficiently conceptualizing, developing, optimizing, and validating production protocols. Qualified and trained employees facilitate improvements in process development and bring together research and production: from the assessment of starting materials; definition of suitable in-process controls (IPC); process qualification and validation; till the approval for batch release.
To accelerate the scaling-up of technologies and processes, the GMP simulation facility offers GMP-compliant equipment in a GMPsim clean room and supports GMP-compliant documentation.
Product portfolio
- Technology transfer from pre-clinical innovation and process development towards GMP production.
- Validated in-process controls (IPC)s and quality control (QC) assays.
- Up-scaling of new or existing production processes.
- Closed-system manufacturing.
- GMP ready cell engineering technologies, using viral and non-viral based modification technologies.
- Standard operating procedures (SOP) implementation
- Process validation plan and transition to GMP production facility for validation.
- GMP qualification dossiers ready for submission, i.e., Investigational Medical Product Dossier (IMPD).
- Training of ICAT personnel involved in production and, if desired, the technicians from the client for production within the GMP production facility.
