| Key
Research Topics
Model-based process design & development & prediction
of product performance, quality and safety from early stage process
parameters
• Development of mechanistic understanding of the
unit operations in the API and formulation processes and the factors
influencing performance, scale-up and manufacturing
• Fundamental scientific knowledge & understanding of
pharmaceutical materials & their interaction and effect on
the quality of the final product
• Development of predictive & scale-up models, design
and control tools for common unit operations: crystallizers, powder
granulation & mixing, aseptic filling, freeze drying
• Prediction of properties and performance of API processes
and drug formulations or processes based on limited data
Quality by Design
• To explore a broad range of issues related to physical
design, characterization, specifications, Process Analytical Technology
(PAT), and quality control
• Application of “Design for six sigma” in product
design and development to reduce variability in scale-up and manufacturing
• Develop systematic approaches to reduce and control process
variability
• Predicting stability and manufacturability
• Reengineering of the development process to reduce time
to market
General process design tools that allow integrated design
of processes
• Pharmaceutical Informatics
• Application of artificial intelligence in drug development
and manufacturing
• Ability to rate projects based on probability of success
and figure out how to distribute resources
• Portfolio management and capacity optimization
Issues with Scale-up of Batch Processes
• Eliminate scale-up where possible - micro-reactors,
simulated moving bed chromatography, nano-reactors
• Novel continuous unit operations that can replace current
batch equivalents
• Integrate API and dosage form processes – why do
we always have to isolate and characterize the API?
• Solid-less manufacture?
• Co-processing – such as spray drying active and
excepients together to improve functionality
• Better mechanistic understanding of some of the different
types of formulations such as soft gels,
Miscellaneous
• Design for protection from contaminants & cross-contamination
- include equipment & outside environment
• Tools and screening methods for detection of counterfeit
drugs
• Tools for aseptic process monitoring and control –
nondestructive, continuous sterility testing
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