Elephant in the Cleanroom

Finding value in small-volume aseptic processing means confronting pharma’s fear of change

By Karen Langhauser, Chief Content Director

Saying goodbye to the Ringling Brothers and Barnum & Bailey circus was a tough thing for me to do. As a child, I was mesmerized by the magic of the circus. As an adult, I was awed by the talent of the performers and wooed by the nostalgia of one of the most iconic forms of American entertainment.

The circus industry is one largely built on tradition, experience, and credibility. Trying to stay profitable in that space is tough - and trying to break into that market is even tougher. Cirque du Soleil, however, pulled it off.

Ringling Bros. set a grand standard for circuses - a massive caravan rolling into town carrying every type of performer from motorcycle-riding daredevils to elephants. In the early ’80s, despite getting off to a tough start, Cirque du Soleil evaluated market demands and realized that rather than trying to do things the way they were always done, a newer, leaner way of thinking was necessary.

So Cirque du Soleil scaled back: no lions, no elephants, no grandeur - just a tent, clowns and acrobats.

Today’s modern drug therapies - complex, targeted approaches to treatment that are resulting in small-batch aseptic products - require that manufacturers step away from tradition, taking advantage of new technologies and exploring new ways of addressing process control and efficiency.

Traditional drug manufacturing required heavy investments in large manufacturing facilities and equipment. The “tried and true” approach to aseptic design and process control, geared toward mass production, may not be optimal, or in some case even feasible, with modern therapies.

I recently read an article by two INSEAD professors about how Cirque du Soleil reinvented the circus. In an attempt explain what Cirque du Soleil achieved, the authors gave the example of a market composed of two oceans: red and blue.

“In the red oceans, industry boundaries are defined and accepted, and the competitive rules of the game are known. Here, companies try to outperform their rivals to grab a greater share of existing demand. As the market space gets crowded, prospects for profits and growth are reduced. Products become commodities, and cut-throat competition turns the red ocean bloody. Blue oceans, in contrast, are defined by untapped market space, demand creation, and the opportunity for highly profitable growth.”

This rings true of modern aseptic processing as well. An industry accustomed to large-scale processing is being challenged to shift its mindset - something that is not always easy for pharma - but the rewards for patients and profits can make it worth it.

As America’s entertainment preferences changed, Ringling Bros. suffered from slumping ticket sales that ultimately made the business unsustainable. The sophisticated eloquence and simplicity of the Cirque du Soleil model seemingly paid off, however. They pushed the boundaries of tradition and consequently, customers were willing to pay a price several times that of traditional circuses.

Today’s aseptic performance demands new flexibility in mindset, and if the industry can overcome that hurdle, I think we are in for a grand performance.