The increasing heterogeneity of biologic modalities has greatly impacted the variety of emerging drugs and mechanisms of action available for patients with unmet clinical needs. However, this has also impacted the CMC space and strategies for clinical development.
Caitlin Mastermann works within this space, leading the Technical Operations team at Gilead Sciences. She is responsible for technical transfer and manufacturing oversight, navigating the changing CGMP landscape amongst this heterogeneity.
In this presentation, Mastermann walks us through Gilead’s flexible platform process which they have spent the last decade developing. This platform allows the company to manage the nascent variability of biologics by leveraging a set of processing conditions and unit operations.
Of course, the variability of biologic modalities is matched by a highly variable supply chain, involving both internal manufacturing assets and external partnerships. Mastermann also walks us through how Gilead strategically manages this variability toward the endpoint of drugs’ speedy entry to the clinic for first-in-human trials.
Manufacturability and biophysical characteristics of your biologics is critical and must be assessed. To do so, Mastermann emphasised the importance of early collaboration with research teams to inform the development of purification processes and analytical methods.
Gilead uses a toolkit approach to modify unit operations and formulations as needed to accommodate the specific requirements of different molecules. Tools within this toolkit allow Gilead to easily swap out unit operations in a modular fashion, which Mastermann called: “Templatized and ready to go.”
The manufacturing strategy at Gilead involves maintaining a sustained raw material inventory and using a portfolio approach with external partners to ensure flexibility and capacity. This allows the company to ensure that they always have the inventory that they need for every manufacturing project.
Lastly, Mastermann outlined the key learnings from Gilead’s platform approach. These include the importance of early research collaboration selecting the right external partners, and taking a holistic view of the entire manufacturing timeline to optimise efficiency.
