Achieving Optimal Cell Harvest For Allogeneic Therapies With Purpose-Built Harvest Technologies

By Jacob Andrews, CARR Biosystems

Achieving optimal cell harvest is important across the development continuum and at every phase of scale-up. While unique challenges exist for all cell therapies, optimizing harvest conditions for allogeneic cell therapies comes with unique considerations to achieve the manufacturing scales required for these promising innovations. Enabling the yields, reproducibility, and larger production volumes necessary to support allogeneic applications will be key to addressing some of the core challenges that have limited their commercialization potential in the past. Much of this optimization centers on standardizing equipment and processes early in development; establishing growth environments, media, and mixing that support improved cell viability; and closing, validating, and (where appropriate) automating workflows. Maintaining critical process parameters (CPPs) such as viability and recovery often requires technologies that provide scalability, automation, and the flexibility to tune processes to achieve cell- and therapy-specific critical quality attributes. For many applications, cutting-edge centrifugation technologies can help achieve this optimization, affording developers and manufacturers a low-shear, high-yield cell harvest that is tightly controlled and highly reproducible.

For many organizations in the early stages of development, manual processing is often the most accessible and appropriate approach to demonstrating an investigational candidate’s promise. However, as a therapy progresses through development, many of these early, hands-on approaches become incompatible with GMP manufacturing processes and highly inefficient to scale. Moreover, the longer a company waits to transition its processes, the more difficult this proposition becomes. While many organizations may reason that a unique asset, with unique process requirements, necessitates they develop a new (often manual) process from scratch, the reality is that by identifying suppliers with the expertise and scalable solution portfolio to support optimized cell harvest, cell therapy developers can ensure that their processes are primed for efficiency, reproducibility, and safety at scale.