Cell therapy developers must think carefully before adopting a decentralized manufacturing model say researchers, who suggest the benefits of bedside production are outweighed by technical challenges.
The advice, presented in a study in the Journal of Translational Medicine, is based on an assessment of current cell therapy production models which found that the decentralized, multi-production site approach is gaining in popularity, particularly in trials.
“For cellular therapy clinical trials involving multiple sites some people are advocating a decentralized model of manufacturing where patients are treated with cells produced using automated instruments at each participating center.”
The authors also note that advances in technology – particularly in closed-system, automated instruments – are fueling the move towards decentralized cell therapy production.
“The nature of these automated instruments and off-the-shelf Good Manufacturing Practices (GMP) reagents makes it feasible for academic laboratories originally designed and set up to process Hematopoietic Stem Cells (HSC) for transplantation to produce more advanced cellular therapies.
While making therapies close to where patients involved in a trial need them has obvious advantages, the authors suggest the challenges involved in ensuring uniformity are considerable.
“Multiple site manufacturing requires harmonization of product testing and manufacturing in order to interpret the clinical trial results.
“Decentralized manufacturing is quite challenging since all centers should use the same manufacturing protocol, the same or comparable in-process and lot release assays and the quality programs from each center must work closely together.”
They also point out that many academic centers are purchasing these automated instruments for point-of-care manufacturing and participation in decentralized multiple center clinical trials.
Given the complexity in ensuring the cell therapies produced are comparable, center-to-center, the authors suggest that such organizations should think carefully when investing in production technologies.
“Before an academic center decides to establish a point-of-care cell processing laboratory, they should consider all costs associated with such a program. For many academic cell processing centers, point-of-care manufacturing may not be a good investment.”