Many companies start out by manufacturing from a modest base, often working from a small business unit and then scaling up operations as demand grows or new product lines are taken on. This is also true for established manufacturers that are developing new products, as they start from a low base, using small-scale laboratory testing before bringing new pharmaceuticals to market. From a benchtop or laboratory operation, a successful pharmaceuticals enterprise can soon migrate to a pre-production pilot plant and then ultimately on to high volume production.
However, the process of scaling-up from low to high volume production is not always a simple task and requires a clear understanding of the critical phases involved – as well as ways to keep these under control as volumes change.
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