DOCUMENT
Smith G (2021) Biologics Form Dev and Drug Delivery June 14-15th Final.pdf (3.85 MB)
PRESENTATION
Smith G (2021) Biologics Form Dev and Drug Delivery June 14-15th Final.pptx (106.97 MB)
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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
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).
