Pharmaceutical Lyophilization
Summit 2019
Discuss best practices in tech & regulatory updates, process, formulation, testing, monitoring and new products development.
- 13 Feb 2019
- Prague, CZ
- Pharma
Day 2:
Thursday, 14 February 2019
BLOCK: FORMULATION DEVELOPMENT.
CASE STUDY: In silico modelling of freeze drying processes.
Development of protein therapeutics formulation relies on the selection of excipients that stabilize protein and/or prevent aggregation.
Experimental strategies to optimize formulations use force degradation studies and involve screening many combinations of excipientsand buffers. However, these effective methods do not readily provide information on intermolecular interactions responsible for the protective effects of excipients.
In silico methods may be employed to evaluate interactions that may form between selected therapeutics during freeze drying pharmaceutical formulations. A combination of molecular docking methods has been successfully utilized to predict hotspots for protein excipient interfaces on a model protein, which were confirmed by molecular dynamics in presence of explicit solvent and buffer components.
Furthermore, simulated annealing simulations of freezing and drying processes provide insights into protective effects of formulations on a molecular level.
This combination of approaches could provide information about the interactions of excipients in formulations and guide the computer aided development of future formulations.
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