As discussed in our previous webinars, as part of the “It’s all about Manufacturing” series, process and analytical development often need to be performed on parallel tracks due to the inherent constraints in time, budget and the availability of appropriate early stage analytics. This is particularly true for smaller startup organisation that often rely on external funding linked to clinical and commercial milestones.
Due to these constraints it's critical to develop phase appropriate processes, that are informed by a holistic CMC strategy where drivers are identified early on in the development journey.
In this webinar we will explore how process and analytical development can be run in parallel effectively with case studies being presented for both an AAV gene therapy and an MSC project example. We will explore how important it is to keep the end in mind and how, by doing this, one can mitigate potential hurdles through effective planning and preparation.
The goal of process development is successful manufacturing, which is what it’s all about.
Key Learning Objectives
- How the development of a process, when thought of as a whole rather than a series of unit operation, can derisk manufacturing
- How to overcome the challenges of using early stage analytics when making process development decisions
- An example of how a targeted process development program can be used to derisk the CMC of novel therapies and aid in funding milestones
