Multiple studies have found continuous bioprocessing reduces commercial cost of goods (COG) by between 10% and 30%, largely because the approach enables smaller manufacturing trains and the implementation of single-use technologies at those reduced scales.
However, the effect of continuous bioprocessing on process development, which with clinical manufacturing is estimated to account for 17% of all R&D costs, is less clear. Higher process development costs could exceed subsequent commercial savings.
Writing in the journal Biotechnology and Bioengineering in April, researchers from University College London and the Centre for Process Innovation presented an analysis intended to show whether end-to-end continuous bioprocessing is cost effective when spending on process development and commercial manufacturing is considered.
The analysis predicted single-use continuous facilities will typically have a cost advantage over stainless steel batch plants. At facilities with annual demands of 100kg to 500kg, continuous bioprocessing has a 35% advantage, although the difference in indirect costs falls to zero at larger sites that need four or more parallel trains to handle 3,000kg a year or more.
Earlier studies suggested the analysis would find continuous bioprocessing has a cost advantage in commercial scales. The bigger question was whether the advantage would be large enough to offset any additional process development costs.
The analysis found large companies, which have multiple drug candidates and therefore spend more on chemistry, manufacturing and controls (CMC), incur a two-fold increase in process development costs when using continuous bioprocessing. That additional spending outweighs the 20% saved on manufacturing, leading continuous bioprocessing to cost large companies around $40m more.