With cell therapy pipelines growing rapidly each year, the need for optimized apheresis collections, a critical first step in the manufacture of many cell therapy products, is evident. Highly variable or poor quality starting apheresis collections present a significant engineering and manufacturing development challenge. From the viewpoint of a CDMO, Minaris Regenerative Medicine has a unique perspective on these issues and recognizes the importance of optimized apheresis collection for immunotherapy in non-mobilized patients and donors.
This white paper will examine the impact of apheresis product quality and variability on various elements that are relevant to cell therapy manufacturing, including manufacturing process development, manufacturing itself, and patient access. Ultimately, we want to ensure cutting-edge technologies and therapies are accessible to patients who truly need them.