Biotech firms often have tight timelines to prove the concept of their NCE. As a result, modern clinical development pathway requires rapid manufacturing of the “first Kilo”.
The procedures typically available to CMOs for early phase manufacturing are laboratory-based processes, which are designed to manufacture a few grams. The goal at this stage is not to generate a long term economically feasible process, but to deliver high quality material in a safe and efficient manner. Key to this is responsiveness and adaptability in the Process Development laboratory. However, by necessity, little attention has been paid to analytical methods, isolation procedures or process safety upon scale-up.