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

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