The course will introduce and discuss the following:
Requirements in order to move from small (less than 1g) supplies to the first 100g or so for preclinical work
Further scaling to 1-2kg non-cGMP
Requirements to make material for use in clinical trial – an introduction to cGMP coupled with the scaling issues
An overview of the requirements to move processes to fixed vessels, assuming cGMP is required – what operations can readily be transferred and those that should ideally be developed out
The phases of development and indicative timelines with quality requirements
The importance of physical form selection, understanding and control
Impurities and their control, with specific discussion on genotoxic impurities and developing the specification for the API as it moves from preclinical batch preparation to cGMP batches for clinical trials
Requirements in order to move from small (less than 1g) supplies to the first 100g or so for preclinical work
Further scaling to 1-2kg non-cGMP
Requirements to make material for use in clinical trial – an introduction to cGMP coupled with the scaling issues
An overview of the requirements to move processes to fixed vessels, assuming cGMP is required – what operations can readily be transferred and those that should ideally be developed out
The phases of development and indicative timelines with quality requirements
The importance of physical form selection, understanding and control
Impurities and their control, with specific discussion on genotoxic impurities and developing the specification for the API as it moves from preclinical batch preparation to cGMP batches for clinical trials
