Autologous cell therapies - the path to commercial viability
Sponsor
Today’s autologous cell therapy footprint has been expanding exponentially over recent years and the recent commercialization of multiple CAR T therapies has continued to ignite the growth of the modality. While there are hundreds of products that are active in the early clinical phases, the focus is shifting from an expedited path to clinical and early regulatory milestones to a focus on the long-term commercial strategy and viability of the drug product. Due to this shift in focus, numerous pain points have been exposed that have created critical bottlenecks affecting the ability for a smooth transition into commercialization and subsequent scale-up of continuous commercial manufacturing.
From critical development needs and product introduction approaches through a digital strategy for both CoI/CoC flowpaths, our autologous expert reveals the approach to commercialization and how to attack critical industry bottlenecks to not only drive a product into the commercial scale, but efficiently scale-up to manufacturing at peak demand.
- The specificities and challenges associated with autologous cell therapy manufacturing
- A focus on compliance and quality while moving through the product lifecycle
- Approach to scaling out from a physical and digital perspective to maximize the commercial viability longevity
SPEAKERS
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