A Structured Analysis of the Novel Technologies used to alleviate bottlenecks in Biopharmaceutical Manufacturing /

Abstract

Biopharmaceutical companies are under increasing pressure to meet the market demand from patients. Despite a high growth sector within the life sciences sector, the same types of manufacturing methods have been employed since the first approval of biologic in the early 1980’s. The bottleneck in biologics processing was originally in the upstream are of manufacturing, because of the low titres achievable in the early biologics cell cultures. However due to advancements in genetic engineering, the improvements in media formulations for cell culture and the introduction of single use technology, as a platform for bioreactors, the bottleneck has swung towards downstream processing. Purification technologies have not evolved at a rate as quickly as upstream technologies and it is now difficult to setup downstream suites in the conventional way, to accept the levels of titres seen in upstream processing. However some novel downstream technologies are emerging to address these concerns, despite the hesitancy from the biopharma industry to engage with them. The following thesis attempts to determine the root causes of the bottle neck shifting to downstream processing, the reasons for the hesitancy to move away from the conventional methods, as well as an analysis of some of the novel downstream technologies available to biologics manufacturing. Furthermore a detailed overview is presented on buffer preparation and the use of In-Line Conditioning Technology as an alternative, to alleviate this bottle neck.