The success of the CHO/antibody platform model has sparked an unprecedented appetite for dramatic reductions in both duration of process development and cost to the supporting organization. This appetite sits somewhat uncomfortably (to the process scientist, that is) with the rapidly growing diversity of formats promoted by research teams eager to establish competitive edge through novel targets and modes of action. Unsurprisingly, tools such as predictive modelling and high-throughput development (HTPD) are widely perceived as critical for ensuring the future success of biopharmaceutical process development. This perception is supported by a sizeable body of success stories demonstrating the potential of either modelling or HTPD to augment individual development challenges. However, the needs of an entire, diverse product pipeline call for a more differentiated view of both strengths and weaknesses of these (and other) tools. As we will show through a number of illustrative cases, a clear understanding of the utility of individual development approaches and their selective deployment to the right product, at the right time, is required to optimally serve the mission of any process development organization: to underpin both short-term clinical and long-term commercial success of a pipeline, no matter its diversity.

Right tool for the job? A critical look at the needs of a diverse product pipeline

249th National Meeting (2015)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.