ATMP manufacturing and QC
In this podcast, Rey Mali, Vice President Sales and Marketing, Accellix, and Félix Montero-Julian, Healthcare Scientific Director, bioMérieux discuss the difficulties in manufacturing and ensuring the quality of cell and gene therapies, why speed is particularly important in their quality control and some of the key technologies involved in these quality assessments.
Rey and Félix also outlined the two key types of critical quality attributes needing to be tested with cell and gene therapies: those that affect safety – the presence of mycoplasma, microbial content and detection of endotoxins – and secondly the cellular quality attributes – cell viability, phenotyping and purity. They added that QC for cell and gene therapies is totally different from QC for even other biopharmaceuticals, such as monoclonal antibodies, because the cells involved are alive. “Every cell from one patient to another may be different,” explained Félix, “so this is challenging to have standardised protocols that can consistently measure [the quality attributes]. We are still discovering how to control these products, what are the best analytical technologies to use and what are the most relevant data… how to use this data to adapt processes.”
We went on to discuss further why speed is crucial in QC, what techniques are currently used for the analysis of quality for cell and gene therapies and how Accellix and bioMérieux are teaming up to bring solutions to market that can reduce the time taken for QC testing from days to hours or minutes. Find out about all of this and more in this podcast: