LAUSR

Continuous bioprocessing has the inherent advantage of higher productivity, which can facilitate implementation of small process trains resulting in cost-effective, lean, and agile manufacturing facilities. Impressive technological advances to enable continuous bioprocessing have been made in the recent past and were discussed at ECI’s Integrated Continuous Biomanufacturing (ICB) III Conference (Cascais, Portugal, 1721 September 2017) chaired by Suzanne Farid (UCL), Chetan Goudar (Amgen), Paula Alves (iBET), and Veena Warikoo (exSanofi, currently Roche). The ICB III conference brought together leading scientists and engineers from academia, industry and regulatory authorities that are actively engaged in continuous bioprocessing to debate how industrialized our sector can become and potential scenarios where continuous platforms will better serve our needs. The conference participants were surveyed on a number of questions related to continuous bioprocessing and a summary of some of the key responses is highlighted in Figure 1. The profile of the survey respondents were approximately 50% biopharma companies, 30% academia, 15% vendors, and 5% government organisations with the majority in process development, manufacturing science and technology or (MSAT) research roles. The survey tackled the question of what a facility of the future might look like and the majority envisioned hybrid facilities with batch and continuous operations, with scale-out or numbering up principles rather than large scaled-up facilities and with ballroom designs. The survey aimed to assess also how many companies were serious about implementing continuous processes. The survey revealed that 40% of respondents were developing continuous and integrated platforms for products starting in Phase 1 and 20% in Phase II or post approval. This suggests a significant shift from previous conferences where there was a large effort in evaluating and demonstrating the potential of continuous processes without necessarily commitment in clinical programs. Hurdles and challenges were addressed from two perspectives, the conceptual design phase and commercialization. During early decision-making, the top 4 hurdles to implementing continuous facility design concepts were complexity and risk (65%), lack of GMP technologies (50%), comparability or quality issues (30%) and management buy-in (28%). Moving toward commercialization, the keywords that captured major challenges were validation, control, quality, and definition as the sector comes to terms with new equipment and a greater need for automation and mechanisms to deal with deviations.