Gavin Walker Bernal Chair in Pharmaceutical Engineering · Next generation “substance”...
Transcript of Gavin Walker Bernal Chair in Pharmaceutical Engineering · Next generation “substance”...
Future Pharma Processing
• Continuous processing, flexible modular equipment
• Process analytical technology (PAT) & Quality by Design (QbD)
• Soft sensors (chemometrics) & Real time release
• Small and large molecules (biopharma), combination products
• Automation, process modelling, process control
Next generation “substance” manufacturing methodologies – computational fluid dynamics - process modelling – enabling automation via digital control systems for design of flexible process modules, model predictive control.
Walker GM*, Bell S, Green K, Andrews G, Jones D.,
Characterisation of fluidised bed granulation
processes using in-situ raman spectroscopy,
Chemical Engineering Science, 64 (2009) 91 – 98
American Pharmaceutical Review, 2009, G.M. Walker
Innovation in Process Analytical Technology (PAT)
May 2015
Enabling Continuous
Processing via Innovation in PAT
McAuliffe et al., (2015) Organic Process Research and Development, 19 (1) 158
Innopharma Labs:
Eyecon, particle size analysisMultieye N-IR, ribbon properties
www.sspc.ie
Innovation in Pharmaceutical Processing
Novel Supercritical Carbon Dioxide Impregnation Technique for the Production of Amorphous Solid Drug Dispersions: A Comparison to Hot Melt Extrusion, Molecular Pharmaceutics, 2015, 12, 1377
Top Schematic representation of supercritical fluid impregnation apparatus; Left: Raman maps collected for (top) IDO/SOL HME, (bottom) IDO/SOL SFI.
www.sspc.ie
Animated Shear stress and Strain in the Peristaltic Pump
Innovation in simulation:
CFD Simulation - Results
Future Pharma Processing
• Continuous processing, flexible modular equipment
• Process analytical technology (PAT) & Quality by Design (QbD)
• Soft sensors (chemometrics) & Real time release
• Small and large molecules (biopharma), combination products
• Automation, process modelling, process control
Next generation “substance” manufacturing methodologies – computational fluid dynamics - process modelling – enabling automation via digital control systems for design of flexible process modules, model predictive control.