Is your active pharmaceutical ingredient ready for good manufacturing practice scale up?

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 CRO services can support you in progressing your drug development journey from route design to process development, ensuring readiness for GMP manufacture.