Scaling from Milligrams to 1-2 kg

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The aim of the course is to provide attendees with a good basis to work from when involved in taking development candidates to the first in human trials with a view also on some longer-term requirements. The course content will therefore focus on the necessary early phases of chemical development as would typically be required to support production of up to about 2 kg using laboratory-based 20 L glassware.

Course Content

• Requirements in order to move from small (<1 g) supplies to the first 100 g or so for preclinical work
• Further scaling to 1-2 kg 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
• 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

During the course, the lessons and the key learning opportunities are considered to be:

• How long does it take to get from milligrams to 1-2 kg suitable for human clinical trials?
• What are the main hurdles?
• What can be left out and what must be included?
• What are the key project management considerations?
  

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