Is Continuous Manufacturing in Your Future?

Is continuous manufacturing in your future? After all, the technology to enable continuous manufacturing of biopharmaceuticals is rapidly being developed. After attending the Chapter’s educational program at Takeda Pharmaceuticals on March 16, my conclusion is that continuous manufacturing is definitely in our future but, as with past transformations in technology, adoption by industry will be slow.

Andre Walker kicked off the evening with “Continuous Biopharmaceutical Manufacturing: Challenges & Possibilities.”  Andre made the point that continuous manufacturing is a transformative technology that could revolutionize biopharmaceutical manufacturing but, due to fear and hesitation to invest in the unknown, general adoption of the technology will occur in steps.  He referred to the example of inline buffer dilution, which is currently being implemented by many companies to eliminate the need for large buffer tank farms.  Eventually these many steps will yield a continuous process.

Ketki Behere followed with a presentation of her thesis work, “Protein A Resin Lifetime Study: Evaluation of Protein A Resin Performance with a Model-Based Approach in Continuous Capture,” which models the degradation of Protein A resin caused by caustic exposure during sanitization. Ketki’s model shows that it is possible to predict the life of the resin. Information from the model can be used to design sanitization methodology that improves the life of Protein A resin.

Kathleen Mihlbachler concluded the program with “Transforming Downstream Processing through Multi-Column Chromatography.”  Kathleen began by describing how multi-columns can be configured for a continuous process and discussing design basics. She then focused on system optimization by reducing complexity, performance verification and the regulatory aspects of multi-column processing.  Kathleen showed us that not only is multi-column processing possible, it is becoming part of the standard downstream processing platform.

The night ended with a lively question and answer session. Questions ranged from people trying to understand “What is this thing called continuous manufacturing?” to a detailed discussion on how to sequence the columns. Everyone in attendance now understands that continuous manufacturing is definitely in their future in one form or another – it’s only a matter of time.

The Chapter would like to thank our generous host Takeda Pharmaceuticals, program sponsor New England Controls, our three superb speakers and everyone who participated in this very interesting and enjoyable night!

For a peek at the presentations, click on the links below:

Andre Walker, CPIP:
https://www.ispeboston.org/files/ispe_march_16_-_walker_handouts.pdf
Ketki Behere:
https://www.ispeboston.org/files/ispe_march_16_-_behere_handouts.pdf
Kathleen Mihlbachler:
https://www.ispeboston.org/files/ispe_march_16_-_mihlbachler_handouts.pdf