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New Process Analytical Technology (PAT) Tools for Freeze Drying

The pharmaceutical industry and the FDA have come to realize that testing quality into the final product is inhibiting the rate of introducing important new drugs. During the past few years the FDA has formulated an important new initiative intended to modernize pharmaceutical manufacturing and encourage pharmaceutical manufacturers to use PAT. The FDA has indicated that drug manufacturers that adopt advanced process monitoring and control techniques may receive favorable treatment. The goal of the initiative is to enable manufacturers to produce drug products more efficiently and with higher quality. To be capable to produce more efficiently in manufacturing while still assuring product quality means that critical process parameters (CPPs) must be specified and controlled within predefined limits (“Design Space”). These specifications, however, must be set by performing experiments in the laboratory and using PAT tools that have the capability to describe all the important process parameters with acceptable accuracy. PAT is a tool-box which includes the use of “smart” sensors that may enhance process monitoring and process understanding during development as well as process monitoring and control during commercial manufacture. With regard to freeze-drying, PAT in the laboratory is more focused on process understanding (i.e. PAT tools should enable a more scientific approach to product and process development), whereas PAT in production scale freeze-drying is necessary for process control and may facilitate scale-up. By applying new process analytical technologies such as Manometric Temperature Measurement (MTM) and Tunable Diode Laser Absorption Spectroscopy (TDLAS), two of the most recent process analytical technologies for freeze-drying, researchers and manufacturers will gain valuable information about their product behavior during a lab or production scale freeze-drying processes. Learn more about the MTM and TDLAS technology here :

                     

PAT in freeze drying is the core competence of our research group. We are working with both MTM and TDLAS technology as well as other monitoring tools used in freeze drying. Our goal for the near future is to establish a concept for PAT in the freeze drying area. However, from our experience over the last couple of years we propose that implementation of PAT really starts much earlier than in manufacturing or the laboratory, i.e. during your formulation work.

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Our actual work includes:

  • Manometric Temperature Measurements (MTM) and SMART ™ Freeze Dryer technology,
  • Tunable Diode Laser Absorption Spectroscopy (TDLAS),
  • Development of new, non-invasive measurements.

 

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