Predictive Scale-up/Scale-Down for Production of Pharmaceuticals and Biopharmaceuticals

Ketterhagen, W. R., Pfizer Worldwide Research and Development
Vanarase, A., Bristol-Myers Squibb

Batch processing in the Pharmaceutical Industry involves a series of unit operations where the synthesis and downstream processing of the chemical or microbiological product takes place in conjunction with mass, heat and momentum transfer. All of these processes are scale dependent and typically involve scaling-up from lab equipment to pilot scale and eventually to full scale commercial operation. Similarly operational issues experienced at full scale manufacturing (poor quality, yield, safety, etc.) require a systematic scale-down approach to the lab scale in order to reproduce and analyze manufacturing problems before implementing solutions. Chemical engineers working in the industry today are faced with the challenge to appropriately plan experiments in the lab in order to tackle such problems using predictive, first-principles based modeling as guide. This session is meant to invite papers that cover both theoretical and applied aspects of such scale-up/scale-down analysis. Papers covering solids processing applications are also encouraged.



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