Time to experiment, time to clinic, and time to market are becoming even more important for developers and manufacturers of biopharmaceuticals. Here we give some insights on tools to make process development more efficient.
Process development landscape is changing and facing new challenges
Historically, the development timeline for a pharmaceutical drug has been 8 to 10 years. However, we are now facing shorter timelines for decision making with the use of expedited programs, such as fast track approval and breakthrough drug designation, which can significantly shrink the development timeline. The consequence of this change is that process development and CMC activities have become even more critical factors in the time to market, with many being performed in parallel with clinical trials.
These pressures, compounded by the need to improve facility efficiency, lead many companies to reuse knowledge to make product development faster and more predictable for current and future projects. This is typically referred to as a platform approach, whether it is for development, manufacturing, or analysis. Each platform can then contain standard operating procedures, checklists, and equipment or raw material selection, in order to ensure a certain performance.