Process analytical solutions for future pharmaceuticals

[learn_more caption=”Jukka Rantanen”] Jukka Rantanen is professor of pharmaceutical technology and engineering at the Department of Pharmacy (University of Copenhagen). He received his Ph.D. from the University of Helsinki in 2001, completed postdoctoral visit at the Department of Industrial and Physical Pharmacy (Purdue University, USA) in 2003, and joined the faculty at the University of Copenhagen in 2006 as a full professor. He has 180+ publications in scientific peer-reviewed journals and he is an editorial board member of four leading scientific journals within pharmaceutical sciences and chemical engineering. Jukka is a member of the Process Analytical Technology Working Party of the European Pharmacopoeia Commission as well as a member of the National Pharmacopoeia Council in Denmark (Farmakopenævnet). He is currently a chairman of the Steering Committee of the EUFEPS QbD and PAT Sciences Network (EUFEPS, European Federation for Pharmaceutical Sciences). Jukka is a board member of Danish Council for Independent Research (DFF) within Technology and Production Sciences. He has been consulting several international companies in the field of process analytical technologies (PAT)/Quality by Design (QbD) and he has developed several PAT/QbD courses for both M.Sc. and Ph.D. level, as well as continuous education directed for industry. Jukka is a founding member of the Pharmaceutical Solid State Research Cluster (PSSRC). [/learn_more]

 

 

Medicinal products are getting increasingly complex with the recent advances within genetics and metabolic profiling. This development is creating a need for more personalized products and therapies. Current generally-accepted manufacturing solutions are not flexible enough to meet the needs of future pharmaceuticals. Lack of innovative manufacturing solutions is one of the major obstacles while implementing novel personalized treatments into practice. Closing the gap between future pharmaceutical products for personalized therapies requires new thinking in the field of pharmaceutical engineering.

There are several innovative technologies with a potential for operation in a continuous operation mode: processing based on hot melt extrusion and 2D/3D printing can be used to manufacture solid dosage forms with desired size/shape and easily adjusted amount of the active ingredient. When applying these technologies for highly-engineered medicinal product, state-of-the-art analytical techniques are needed. One key element of future manufacturing systems will be the effective implementation of process analytical toolbox. Current development of process spectroscopy has enabled totally new insights into manufacturing of pharmaceuticals. Infrared (IR), near infrared (NIR), Raman and terahertz (THz) spectroscopic techniques are widely used within different application areas. Imaging using different principles can be utilized for capturing information related to critical quality attributes. This development together with the utilization of chemical mapping (spectral imaging) and robust multivariate data analytical tools will pave the way towards future pharmaceuticals.