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By William G. Whitford, Sr. Market Manager, Thermo Fisher Scientific

In 1865 Jules Verne popularized the idea of a moon landing in From the Earth to the Moon. However, it wasn't until over one hundred years later that technology caught up sufficiently to accomplish the feat (Apollo 11). So, it just may be that the long-discussed idea of continuous processing (CP) in bioproduction may finally be approaching realization. The power of continuous processing (or production) has been recognized as since its application to the oil and chemical manufacturing in the late 19th century. Its popularity stems from the values it provides in efficiency, economy and quality.

It's been over eight years since the FDA articulated, in its PAT guidance, the goal of "facilitating continuous processing to improve efficiency and manage variability" in pharmaceutical manufacturing. Since that time there has been a steady development of the concept in the literature. This includes reviews of how and why the industry in general has had difficulty realizing the vision. But, there has been in particular less activity with respect to biopharmaceutical manufacturing - where we have seen very little in the way of systems design, not to mention implementation. In fact, the possibility of a continuous flow process for bioproduction has been often met with considerable skepticism.

Examination of the values imparted to production by a CP approach illustrates why the idea was adopted by other industries so long ago. Promises from CP include both increased profitability and improved product quality. Profitability comes from such things as increased efficiency in facility utilization; shorter batch cycle times, and reduced intermediate material storage and handling. Product quality benefits derive from support of (if not reliance upon) PAT goals, a simplified process stream, more concentrated raw product, lower reactor residency time, shortened production train, as well as greatly increased processing parameter consistency.