Van Kley (Cambrex): When developing an API manufacturing process, there are a number of important considerations from a practical and logistical standpoint. Firstly, can the chemistry be performed at ...

Sound process understanding and having effective controls in place are crucial in ensuring that consistent product quality is obtained during API manufacturing. The pharmaceutical contract ...

In this interview, NewsMed talks to Dr. James Mencel's Guidance about Scaling Up API Processes. Could you introduce yourself and your experience in the pharmaceutical industry? I obtained a B.S. in ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...