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6 Sep 2021

What is the meaning of scale up in pharmaceutical industry?

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A Scale-up is an important concept in pharmaceutical and biopharmaceutical manufacturing industry.

It is defined as to take a biopharmaceutical manufacturing process from the laboratory scale to a scale at which it is commercially feasible.

It is to increase the size of something whilst maintaining proportion or to change a process in order to allow for greater quantities.

Laboratory-scale batches are those that are made when the drug is still being tested from its time in the lab to clinical trials. The next level is pilot-scale which may be for the purpose of expanding clinical trials, or for mid- to later stage clinical evaluation. Pilot-scale is usually about 10% of the production-scale, which is also known as commercial scale. When a drug is approved and in demand it will be produced at the commercial-scale batch size. If demand increases, production may be expanded to other facilities and in some cases to other countries.

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