Continuous Biopharmaceutical Manufacturing – Possible, Improbable, or Unavoidable?
- Posted by Andre Walker
- On March 6, 2017
I don’t remember a lot of effort going into learning about batch processing in my chemical engineering studies. Continuous processing was the norm in refineries and many chemical plants. Steady state equated to even quality, and output could be tuned for maximum efficiency. The world revolved around a well understood material balance. Batch was for bakers and brewers. One wonders then, why almost all unit operations in biopharmaceutical production are batch in nature. Is there anything fundamentally different about biopharma operations that keep us from the transformative benefits gained by the steel and other industries when they converted to continuous processing?
The answer is clearly “yes” we are different than those other industries; but “no” those attributes need not keep us from making the journey to CBM. Solutions to the anxiety-provoking questions about batch definition and traceability were revealed when the FDA approved two small molecule compounds manufactured continuously in 2016. Furthermore, process developers, assay scientists and engineers, in pursing incremental improvements, are often inventing the solutions that will enable CM for biologics in the future. The true barrier to CM for biologics is inertia of thought and capital. There are proven (batch processing based) methods of expanding capacity and markets; pursuing unproven CBM technologies isn’t one of them. Yet most good ideas find a toehold where conditions are right. Where will that fertile ground exist for CBM?
If this has piqued your interest, then consider attending the Boston Area Chapter’s March 16 program, “Continuous Manufacturing of Biopharmaceuticals.” An overview of the challenges and possible solutions will be followed by two technical presentations demonstrating that CBM can (will?) be a reality for our industry. If you haven’t thought much about CBM, perhaps now is the time to begin learning about the future.
Even Brewers use Continuous Processing: http://nzic.org.nz/ChemProcesses/food/6A.pdf
An In-depth look: https://iscmp2014.mit.edu/white-papers/white-paper-4