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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 17.06.2021, 11:16 by Geoff SmithGeoff Smith
cite as :

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

Topics covered by this talk:

- Introduction to freeze-drying and process analytical technologies

- Through-vial impedance spectroscopy (TVIS)

- Multiplexed PAT with impedance measurements

- Characterization of critical process parameters:
• Ice nucleation temperature (𝑇n)
• Phase behaviour of solid/solute fraction
• Ice interface temperature (𝑇i ) < 𝑇c
• Primary drying end point

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).


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