Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate

By William Whitford, Strategic Solutions Leader, BioProcess, Cytiva

By William Whitford, Sr. Manager, HyClone Cell Culture, Cytiva

The industry is abuzz with talk about continuous biomanufacturing (CB), and it virtues have been well described (1). Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology. 

1. Economic Justifications And Investment Risks

Everyone concedes continuous processing is the very best way to produce many products, from gasoline to shortbread. But, what specifically will it contribute to the bottom line in monoclonal antibodies (MAbs), enzymes, and vaccines (2)? What are the capital expenditure (CapEx) and operational expenditure (OpEx) parameters? How does the diminishing contribution of API costs to some total costs fit-in? And, beyond simply looking at the batch vs continuous equation, what about such other variables as single-use manufacturing or ballroom-based flexible facilities (3)? These good questions are now being addressed using multi-attribute, risk-based tools. Intermediate answers are now being provided by many of the best experts in the bioproduction world (4). Start-up and shut down material losses and costs: This question is easily calculated once a particular continuous operation is designed. There really should be no mysteries here.

2. Performance Reliability (Incidence Of Failure)