by Paul Cashen, Senior Bioprocessing Specialist, Pall Scientific and Laboratory Services
Each step on the pathway to regulatory approval comes with its own considerations and criteria that must be satisfied before being able to progress to the next. Firstly, the product must be shown to work, and must be able to be sufficiently scaled-up to produce an appropriate number of doses per batch. Secondly, the product must pass through several clinical trial stages to demonstrate it is safe and effective. That being said, there are still some key principles with regards to process development that must be adhered to in order to ensure that these products successfully progress through clinical trials into commercialization. COVID-19 has shown us that products can be developed, scaled-up, manufactured, and approved in very short time frames (under exceptional circumstances), but it cannot be expected to be the new normal for every new biologic developed. Underpinning all this work is the documentation – key to any regulatory submission: Chemistry, Manufacturing, and Controls (CMC).
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