Process Analytical Technology and Quality-by-Design for Animal Cell Culture

作者: Stephen Craven , Jessica Whelan

DOI: 10.1007/978-3-319-10320-4_21

关键词:

摘要: Process Analytical Technology (PAT) is an area of intense research and interest currently. The in applications for PAT span many industries: petrochemicals, bulk chemicals, food, pharmaceuticals biopharmaceuticals amongst others. Adoption the biopharmaceutical industry its infancy but being driven by both regulatory demand business case. Ultimately, motivations stem from fact that effective application to bioprocesses increases process understanding control, mitigating risk substandard drug products manufacturer patient. In order realise value can offer, all aspects system must be considered appropriately chosen. These include instrument, data analysis techniques, control strategies algorithms optimization. It only clear definition objective selection suitable elements may realised. This chapter will discuss instruments, techniques relevance animal cell culture

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