FUTURE SUPPLY MODELS


Advancing quality control measures vital for cell and gene therapy development


Despite the high level of specialisation involved in cell and gene therapies, quality control (QC) for these drugs is still done with pen and paper.


ABIGAIL BEANEY, HEALTHCARE REPORTER, CLINICAL TRIALS ARENA


Veeva is hoping its technology can speed up the QC process. Credit: shisu_ka via Shutterstock.com. A


s cell and gene therapies continue to take the clinical trial space by storm, the drug development market is becoming more advanced by the


day. Surprisingly, however, much of the quality control (QC) processing for these drugs is still done with pen and paper, even within the big pharma corporations. Patients who need cell and gene therapies often have a greater disease burden and


32 | Clinical Trial Supply Handbook


necessary procedures such as apheresis can take a toll. This, added to the quick turnaround time required for these therapies, means that every part of the development process must be as quick as possible. Therefore, there is a need for software solutions to assist with the QC process. In September 2023, the software company


Veeva announced its new Batch Release software, which will assist in speeding up this process.


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