Going beyond candidate nomination
Developing a small molecule active pharmaceutical ingredient (API) is often a risky process. Reaching the goal, be it first in human studies or commercial manufacture, requires data and material without incurring unnecessary delays or impact on costs. Therefore, it’s important to start thinking about process steps and scalability early.
During this webinar, you will learn:
- how to assess your process, from safety to efficiency and robustness, as well as understanding the solid form
- the importance of having strong analytical methods to detect impurities and understand their impact, and what supporting analytical data is required prior to good manufacturing practice (GMP) manufacture which makes part of investigational new drug/investigational medicinal product dossier (IND/IMPD) filing
You will also learn how Concept Life Sciences can support you in progressing your drug development journey from route design to process development, ensuring readiness for GMP manufacture.
- David Fengas - Director of CMC Services - Concept Life Sciences and
- Caroline German - Technical Director - Concept Life Sciences
Who should attend?
- Anyone interested in material characterization to support process development
- Anyone who is ready to take their API candidate into early development
- Anyone who is interested in finding out the IND submission requirements
- Anyone who is interested in finding out more about route design, process development and phase appropriate scale up
What will you learn?
- When to look at route design
- SELECT criteria
- Method development and validation
- keys to process robustness detecting your impurities
- How to be GMP ready
- importance of data in regulatory submission