Department of Pharmaceutical Analysis

Dr. Margot Fonteyne

Obtained degree of Doctor in Pharmaceutical Sciences in 2014 at:

Laboratory of Pharmaceutical Process Analytical Technology
Ottergemsesteenweg 460
B-9000 Gent (Belgium)

Education: Pharmacist (Master in Drug Development)

Implementation of PAT systems in pharmaceutical continuous production processes

Continuous production can overcome the time-consuming problems of batch production. In the classic batch system, once a drug is developed on the bench, lab scale has to be scaled-up to full commercial production.   This is not only expensive, but it also prolongs the time-to-market. In a continuous line changing from development, pilot, clinical or commercial production just needs a longer run.

It is possible to use this line lights-out, 24 hours. If the industry is a bit reluctant, that is because the two main advantages of batch production (safety and quality) have to be assured. Since batch-production needs sampling and sometimes rejection of a whole batch, it is certainly worth the effort to innovate production methods in the pharmaceutical industry. It is clear the quality has to be designed into the product, therefore the production has to be well designed and the process has to be fully understood and controlled. This is exactly what the FDA wants to obtain by encouraging the industry to implement PAT (Process Analytical Technology) in their production lines. The drugs produced in such a line will be all of the same quality during the whole runtime and are immediately ready for the market.

Detecting and understanding what is happening during the process is one thing. The aim of this study is to use this data real-time. Implementing all process variables in a computer system will allow continuous feed-back to the production line.

Publications

  • Fonteyne, M.; Fussel, A.L.; Vercruysse, J.; Vervaet, C. ; Remon J.P. ; Strachan, C.; Rades, T. ; De Beer T. (2013). Distribution of binder in granules produced by means of twin screw granulation. International Journal of Pharmaceutics, 462, 8-10.
  • Fonteyne, M.; Vercruysse, J.; Córdoba Díaz, D.; Gildemyn, D.; Vervaet, C.; Remon, J.P.; De Beer, T. (2013) Real-time assessment of critical quality attributes of a continuous granulation process. Pharmaceutical Development and Technology, 18, 85-97.
  • Fonteyne, M.; Soares, S.; Vercruysse, J.; Peeters, E.; Burggraeve, A.; Vervaet, C.; Remon, J.P.; Sandler, N.; De Beer, T. (2012) Prediction of quality attributes of continuously produced granules using complementary PAT tools. European Journal of Pharmaceutics and Biopharmaceutics, 82, 429-436.
  • Vercruysse, J.; Córdoba Díaz, D.; Peeters, E.; Fonteyne, M.; Delaet, U.; Van Assche, I.; De Beer, T.; Remon, J.P.; Vervaet, C. (2012) Continuous twin screw granulation: Influence of process variables on granule and tablet quality. European Journal of Pharmaceutics and Biopharmaceutics, 82, 205-211.
  • Mortier, S.T.; De Beer, T.; Gernaey, K.V.; Vercruysse, J.; Fonteyne, M.; Remon, J.P.; Vervaet, C.; Nopens, I. (2012) Mechanistic modelling of the drying behaviour of single pharmaceutical granules. European Journal of Pharmaceutics and Biopharmaceutics, 80, 682-689.
  • De Beer, T.; Burggraeve, A.; Fonteyne, M.; Saerens, L.; Remon, J.P.; Vervaet, C. (2011) Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes. International Journal of Pharmaceutics, 417, 32-47.
  • Grohganz, H.; Fonteyne, M.; Skibsted, E.; Falck, T.; Palmqvist, B.; Rantanen, J. (2010) Classification of lyophilized mixtures using multivariate analysis of NIR spectra. European Journal of Pharmaceutics and Biopharmaceutics, 74, 406-412.
  • Grohganz, H.; Fonteyne, M.; Skibsted, E.; Falck, T.; Palmqvist, B.; Rantanen, J. (2009) Role of excipients in the quantification of water in lyophilized mixtures using NIR spectroscopy. Journal of Pharmaceutical and Biomedical Analysis, 49, 901-907.