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1. Discuss the rational for using lyophilisation process for biopharmaceuticals. (8 marks)
2. Describe a typical freeze-drying cycle with the stress on critical process parameters and sample performance/properties.
3. Discuss various methods typically used to assess a quality of the lyophilised products (i.e. proteins).
4. Using JMP program produce a DoE for formulation development of protein-based lyophilised product prepared from solution with specific concentration of protein and few excipients (selected from literature). Suggest 3 outputs and corresponding methods to assess them.