Ths purpose of this module is to provide the student with an in-depth knowledge of drug processing from lead compound selection to finished product, focusing on key critical attributes such as scale-up, process optimisation, technology transfer, crystallisation, and control systems
Process Development
Lead compound selection; strategy and planning for scale up; chemical route selection; yield and process optimisation; difficult to scale processes; solvents and materials choice; application of green chemistry, technologies, packaging to drug processing; cost calculations; batch versus continuous processing
Technology Transfer to Manufacturing Plant
Technology transfer process and documentation; how to write batch manufacturing records; how to decide on in-process controls and specifications; impurity identification and troubleshooting; thermochemical hazards; hazard assessment methods; physicochemical issues - competing reactions, mixing and product selectivity issues; production scheduling; online monitoring - PAT; case studies; waste minimisation and solvent recovery
Crysallisation and Crystallography
Crystal growth process; production and handling issues; polymorphism; classification of crystals, including point group and space group symmetry; characterisation of crystals and crystal habit - SEM; XRD, case studies.
Process Control
Critical operating parameters; mass and energy balances; heat control systems and exchangers; design of process control systems; process simulation
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 30 |
| Formal Examination | 70 |