Upstream Continuous Process Development

Recent research has focused on implementation of continuous upstream, continuous downstream, and continuous processing for production of several biologics, primarily monoclonal antibodies. This chapter describes various approaches used for upstream process development with more emphasis on continuous manufacturing platform being developed and practiced in biomanufacturing industries for the production of an affordable and cost-effective therapeutic protein. It describes features of several cell retention devices used so far by industries for continuous upstream process. The chapter constitutes current updates on various platform technologies potentially used for continuous upstream process development for the manufacturing of potential therapeutic products. There are mainly three types of upstream processes practiced largely by biopharmaceutical industries: batch, fed-batch, and continuous processing. Among these processes, the fed-batch process has been the preferred choice by biopharma industries, mainly due to its ease of development resulting optimal yield and desirable product quality.