Is Your API Ready for GMP Scale Up?
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.
Watch this webinar to learn about:
- 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
- What supporting analytical data is required prior to good manufacturing practice