Voices: Kuehn

Innovation Is Often a Journey

Technology offers a path to achieve operational and competitive leadership, but it’s in the application that drives true innovation

By Steven E. Kuehn

As I ponder the significance of the 27 technologies the Pharmaceutical Manufacturing editorial team picked to highlight for this year’s roster of All-Star Innovators, I can’t help but marvel at the macro and micro “innovations” these players have brought to Pharma’s operational table. But for all the efficiencies these technologies have the potential to deliver, they’ll never be realized if they aren’t implemented well and applied correctly.

Our All-Star Innovators for 2014 offer developments that serve to provide key functionality and design features that support operational and process excellence. From sensors that provide simple plug-and-play installation to provide process engineers reliable process data streams, to a single-use heat exchanger that replaces a less than optimal single-use solution, or an expensive stainless-steel system in a single-use train, the Pharmaceutical Manufacturing All-Star team certainly has the skills to perform.

In a sense, though, those skills are discreet — that is, apart from potential operational gain unless and until these technologies are integrated properly into the systems and processes Pharma uses to manufacture products. For many operational types, barriers are constantly being thrown up — hurdles that are preventing even the best, highest potential technologies from being acquired and implemented. Fortunately, the industry’s technology suppliers are also getting better at clearly articulating the value their solutions can provide, often in dialects that financial and executive managers understand and use to justify allocating the resources to acquire said solutions.

In June, I had the pleasure of attending Rockwell Automation’s user group meeting where I was exposed to a great case study of how a biopharmaceutical company is pursuing its own innovation and operational excellence agenda via the application of information technologies. Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing biopharmaceutical therapies in the fields of infertility, obstetrics, urology, gastroenterology, endocrinology and osteoarthritis.

Growth has been especially strong for the company, but like any company, one of the toughest things to do is manage such growth effectively. Ferring, like most biopharmaceutical companies of its age and legacy, supported its batch processing production cycle with a paper-based batch record keeping system. The rub for Ferring was that because all of its batch information was generated via paper-based methodologies and embedded in standard operating QC procedures, the time from batch manufacture to release extended to some 44 days or more — quite a lag and completely unacceptable both tactically and strategically for the company in the long run. In 2010, Ferring began its innovation journey by implementing an eBR/MES solution at its premier Saint-Prex, Switzerland, facility. Jerome Repiton, Ferring’s associate director of its Lean Six Sigma program, explained to attendees that what took the most time was the QA/QC qualification testing and review that took weeks and often occurred well after the product was made: “You can’t manage a product without information, and compliance is impossible without information,” he says.

For Ferring, implementing this IT-based solution created both a process quality and quality assurance process improvement program. Ferring is now able to track “time in process” and that includes time spent in QA/QC review. According to Ferring, time in process has been essentially halved — a dramatic improvement and one of the project’s primary goals. Bottom line: Since the eBR/MES program began in 2010, the number of batches processed by Ferring has jumped from 7,000 to 11,000, a 56% leap in just five years with the same amount of staff. “Quite a return on investment,” said Repiton.

That’s just one example, but it shows that if a company’s operational executives have the will, and pursue innovation through a well thought-out and well-articulated plan, significant rewards can be measured both in the short and long term. Ferring knew where it had to go, but without the innovative solution of its eBR/MES creator, its journey to operational excellence may have been a lot longer.

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