Scientists at the Cell and Gene Therapy Catapult in the U.K. cite using HemaCare leukopaks to study a new method of scrutinizing cellular quality markers during cell therapy bioprocessing. [1]
The publication represents a collaborative effort among scientists developing cellular therapies in the United States and Canada as well as in the U.K. They are working together to solve a key issue; how to ensure the consistent high quality of their living products.
Last week in Part 1 of our series, we presented observations from industry leaders into how they plan for success by installing comprehensive quality management systems and laying down detailed groundwork for an optimized transition to GMP-compliant starting materials and technologies. This week in Part 2 of our series, cell therapy manufacturers present their own perceptions of what constitutes an ideal cell therapy starting material supplier, as well as what can be done on their end to ensure their cell therapy retains consistent quality and potency.
The emergence of cell and gene therapies onto the global stage is generating growing excitement, as unprecedented clinical success fuels the expectation of a promising new chapter in medicine. Alongside an extraordinary increase in the number of cell and gene therapies entering clinical trial, there are a lower yet still significant number of companies launching the commercialized manufacture of their cell therapy products.