Time to experiment, time to clinic, and time to market is becoming even more important for developers and manufacturers of biopharmaceuticals. At the same time, the amount of data enclosed in biologic license applications are more comprehensive to avoid extended review.
With projected peak sales of therapeutics only a few years after launch, processes and facilities must be flexible to quickly adjust to a change in demand. Flexibility is also required for changes in capacity, given the uncertain forecast for biologics. Furthermore, as today’s pipelines have an increasing number of more complex and diversified molecules, process development organizations face significant challenges.
Smart process development is a collection of approaches to make process development better and faster—providing the developers with tools to face the rapidly changing landscape.
In this webinar we will review three fields that enable reduced timelines and improved outcomes of process development activities:
- In-silico process development and data-driven decisions
- Management of process variability through deeper process understanding
- Use of high-throughput methodologies