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Non-invasive spectroscopic methods for single-vial PAT in biopharmaceutical freeze-drying. On-line presentation at Marcus Evans 12th Biologics Formulation Development & Drug Delivery Forum June 14-15th 2021

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posted on 2021-06-17, 11:16 authored by Geoff SmithGeoff Smith
<div>cite as :<br></div><div><div><br></div><div>Smith, G. (2021) Non-invasive spectroscopic methods for single-vial PAT in biopharmaceutical freeze-drying. On-line presentation at Marcus Evans 12th Biologics Formulation Development & Drug Delivery Forum June 14-15th 2021</div><div><br></div><div>Topics covered by this talk:</div><div><br></div><div>- Introduction to freeze-drying and process analytical technologies</div></div><div><br></div><div>- Through-vial impedance spectroscopy (TVIS)</div><div><br></div><div>- Multiplexed PAT with impedance measurements</div><div><br></div><div>- Characterization of critical process parameters: </div><div>• Ice nucleation temperature (��n) </div><div>• Phase behaviour of solid/solute fraction </div><div>• Ice interface temperature (��i ) < ��c </div><div>• Primary drying end point</div><div><br></div><div><p>This work was undertaken in collaboration with Dr Paul Matejtschuk from the UK’s National Institute for Biological Standards and Control (NIBSC, South Mimms) and co-authored by Pathum Wijesekara (PhD student at De Montfort University).</p><br></div>

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