Scaling from Milligrams to 1-2kg
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 2kg using laboratory-based 20L glassware.
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
Benefits of Attending
How long does it take to get from milligrams to 1-2kgs and is 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?
Who Should Attend
Project managers and those involved in technical outsourcing
Project leaders and bench chemists involved in preparation of material
New starters to the area
Medicinal Chemistry support teams involved in making the first batches for toxicological evaluation
The course fee includes:
- comprehensive course manual
- coffee/tea refreshments breaks throughout each day
- buffet lunch each day
- course dinner on the first evening
- course certificate