Gavin WalkerBernal Chair in Pharmaceutical Engineering

February 2017

Since 2013: ~€86 million investment in Science & Eng.

Capital Investment –Buildings & Equipment

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.

“The bench scale

results were so good

that we by-passed the

pilot plant”

Future Directions: Process Modelling