Biopharmaceuticals are typically more difficult to manufacture than small molecule drugs, but cell and gene therapy products pose even greater challenges. When working with stem cells, agitating the cells even slightly too much when they are growing on microcarriers, for example, could stimulate the cells to differentiate along the wrong pathway, affecting yields and potentially creating the wrong product. Other steps in the manufacturing process, such as cryopreservation, can also affect cell viability, so it is crucial that cell therapy producers understand both their product and every step of their processes. According to process engineer Kim Nelson, Senior Director, Strategic Consulting, at CRB, automation can go a long way to facilitate cell therapy manufacture. There is just one problem – integrated off-the-shelf automated systems don’t yet exist. We catch up with Nelson to find out his thoughts on the conundrum and the future of the field.
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