Inhalexpert (QbD), Nir-Industry (PAT) and Galenisys Pharmaceutical Consultants (Validation) create ProcessControlExpert 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 “ProcessControlExpert” 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.

  • Qualitative and quantitative blending monitoring with PAT

  • Process improvement

  • Use of QbD for better understanding

  • QbD training and project support for a CDMO

  • Monitoring and sorting of filled syringe by NIR PAT

  • Moisture monitoring, sorting and release of lyophilised vaccin vials by NIR PAT

  • Mites culture monitoring by imaging + IA

  • Mathematical modeling

  • At-line hydratation monitoring of hyaluronic acid by NIR PAT

  • Qualitative & quantitative monitoring of high shear granulation with NIR PAT

  • Development of a semi solid DP

  • Development of 4 Drug Products according to QbD

  • Development of 3 Drug Substances according to QbD

  • Development of 3 different injectable DPs

  • Capability training

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