Cell Therapy Manufacturability Program
to optimize manufacturing, lower COGs, and increase patient access
While cell therapies have demonstrated exceptional efficacy, patient access and COGs continue to be a major concern. It is possible that, with time, the sector can mature, as monoclonal antibody manufacturing has. However, following a conventional path, maturation of the sector may require decades - and a tremendous financial investment. During this time, patient needs will remain underserved.
FINANCIAL TOOLS
Key Challenges
Understanding and optimizing manufacturability of cell therapies has proven to be a difficult problem to solve due to a number of profound challenges.
Data Silos
Cell therapy manufacturing data is fragmented within and across organizations.
Combinatorics
The manufacturing process is multistep, and there is a large number of novel technologies that have emerged for each step. Testing each combination is not feasible.
Small Data Set Size
The number of patients treated with cell therapies is small, and no one therapy developer has sufficiently large data set to query with statistical significance.
Vein-to-vein data ecosystem™
An end-to-end data set that keeps data in the hands of those who own it enables correlative analyses with most important parameters, i.e. clinical outcomes. This computational approach can offer answers to the key questions.
EARLY GO/NO-GO
Define criteria based on manufacturability
PROCESS RECOMMENDATION
Define process/technology combinations most likely to lead to manufacturable therapies based on cell type/indication etc.
PRECLINICAL MODEL RECOMMENDATION
Identify preclinical models predictive of clinical outcomes in specific indications