Scaling from Milligrams to 1-2Kg
see at…………..http://news.scientificupdate.co.uk/index.php?action=social&chash=1c1d4df596d01da60385f0bb17a4a9e0.1201
2 – 3 March 2015
Sheraton Fisherman’s Wharf Hotel – San Francisco
The aim of this professional development course is to provide a good basis to work from when involved in taking development candidates to the first in human trials and with a view on some longer-term requirements. The course content will focus on the necessary early phases of chemical development, as would typically be required to support production of up to about 2kg.
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
Your Course Tutor
Dr John Knight
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