2019-04-17T09:36:33+00:00 sample questions

Discuss various methods typically used to assess a quality of the lyophilised products (i.e. proteins).

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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. 
(15 marks)

3.    Discuss various methods typically used to assess a quality of the lyophilised products (i.e. proteins).
(12 marks)

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.
(15 marks)


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