Recent Technological Advancements in Medicines Manufacturing
May 16, 2023
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The manufacture of medicines must draw on expertise from a wide range of disciplines, from the initial investigation and design of a new drug or therapeutic to wide-scale production and distribution, also considering the additional quality control measures that must be upheld throughout these stages with regard to pharmaceutical products.
Generally, pharmaceutical products are produced in batch processes with multiple discrete steps, often necessitating lengthy storage periods while quality testing is performed or the equipment required is prepared after the previous batch.
Fluctuations in demand are also difficult to respond to using batch production since the batch currently in production must be completed, and scaling up would require larger equipment. Instead, the FDA encourages drug manufacturers to switch toward continuous production processes. Raw materials are fed into a fully integrated assembly line that completes the production of the desired product in a single run, allowing production to be scaled to demand quickly and efficiently manner.
Tracking and tracing of products in the event of a recall may actually be easier during continuous production processes as rather than recalling the entirety of a batch, the scale of which is determined by the size of the equipment utilized, products can be time-stamped with when they left the assembly line, allowing the recall of products at a particular time plus or minus a few minutes.