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.

More from this voice...

Title

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

07/07/2014

Who Really Designed the Design Space?

Quality by Design is a great idea for Pharma, but some dispute its industry origins

06/02/2014

Assuring Drug Safety in a Global World

Margaret Hamburg tells British regulators she’s having a little trouble sleeping at night

05/09/2014

An Encounter of the Viral Kind

At Interphex I met a bug I didn’t like and lots of things pharmaceutical that I did

04/28/2014

Pharma’s Global Climate Change

Manufacturing pharmaceuticals is not for the faint of heart, no matter where you’re from

03/24/2014

Contract Pharma Takes the Field

Contract services companies are playing great cGMP ball

02/21/2014

A New Capacity for Change

Dollars are flowing fast into cost effective and efficient pharma manufacturing capacity

01/20/2014

Incentivizing a Culture of Quality

From the lab to commercial process and across the global supply chain, quality is a gift we all can share

12/18/2013

Large Molecules, Larger Impact

The biopharma industry remains one of the most robust and healthy of industries, not only in the states, but also around the world

11/13/2013

Lean Forward, Pharma

Operational excellence requires collaboration and efficient allocation of resources

10/10/2013

Chasing the Dragon in China

China's crackdown may ultimately prompt better, more ethical behavior by capitalist and communist alike

09/20/2013

Enter the Innovators

Whether cheaper, faster, safer or easier, innovation puts the “-er” in Pharma manufacturing’s progressive improvement.

08/26/2013

Finding the Good in GDUFA

Providing funding certainty to the FDA’s Office of Generic Drugs will help unjam the ANDA backlog, but many see the fee structure unduly burdening smaller players

06/11/2013

We Are All Bostonians Now

Pharmaceutical industry among the tragedy’s first responders

05/20/2013

Here’s to the Next 10 and 50 to Follow

A happy 10th anniversary to both the FDA’s Pharmaceutical GMPs for the 21st Century as well as Pharmaceutical Manufacturing magazine

04/23/2013

Germs, Vaccines and Stainless Steel

Biopharma continues to shape human history, fighting the good fight against germs and chronic disease; winning through innovation and sometimes, just plain old persistence

03/14/2013