Inhalexpert (QbD), Nir-Industry (PAT) and Galenisys Pharmaceutical Consultants (Validation) create PAT-EXPERTS platform,the first complementary, innovative and operational Competence Centre for Development, Industrialisation and production in (bio) pharmaceutical, chemical and Food & Feed industries.
To control manufacturing process, this synergy of services associates :
- The pragmatic approach of “Quality by Design”, to define critical sources of process variability and impact on DP CQAs.
- PATs to monitor, manage and improve processes in non destructive and real time analysis
- Modeling to predict DP CQAs
- Validation of analytical methods involved in Quality by Design and PAT.
The added value of our “PAT-Experts” platform is as follows:
- To have better manufacturing process control in order to have better control of drug product
- To reduce the costs of poor quality
- To increase efficiency (cost, cycle time and dossier) including Real Time Release
- To control analytical methods and modifications
- To comply with EMA and FDA requirements.
Different technologies available :
- NIR Spectroscopy
- RAMAN Spectroscopy
- Tomography ERT, ECT, EIT