Technology Transfer in Pharmaceutical Industry

Process Signatures: How can you stop worrying & start loving Scale Up

Process signatures capture the scale-independent relationships for a given unit operation or unit process. They represent scale-up or transfer rules that can be used to seamlessly move processes from one equipment to another, from site to another etc. Process signatures are based on the tenet that achieving process similarity is the same as achieving similarity […]

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Fundamental Understanding of Pharma Process

Pharma processes are among the more complex processes in the chemical industry. Over the past decade or so, the traditional “quality-by-testing” approach of trial-and-error is being consciously replaced, partly or fully, by a more scientific approach across all aspects of pharmaceutical engineering – discovery, development and manufacturing. This “Quality by Design (QbD)” paradigm – which

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