Resources Center
Scale-Up of Cell Cultures : Impact of Bioreactor Environment
Growing mammalian cell cultures in bioreactors is a complex activity - scaling up such cultures must consider both biological and engineering aspects. Cell lines, when they are grown in shake-flasks, exhibit growth characteristics that are vastly different from those observed when such cultures are grown in agitated bioreactors. It would almost seem like the cells somehow “know” that they need to ...
Process Metrics: The Keystone of Process Understanding
Process metrics or PMs, are characteristics of a pharmaceutical process that are critical to ensuring product quality and process performance. They are characteristics of the processing ‘micro-environment’ for a given unit operations equipment or ‘process asset’. Generally speaking, maintaining these CPMs at the same (or nearly same) values across scales is a necessary condition for maintaining pr...
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 in the processing environment (insid...
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 is a ris...