By: Steven Kuehn, editor-in-chief, Pharmaceutical Manufacturing
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.
With historical roots extending back to the 1950s Ferring continues to be a pioneer in developing and selling pharmaceutical products based upon natural, pituitary-produced peptide hormones. Over the past few decades, Ferring has developed a strong international profile; In-house production of its award-winning therapies is carried out in Argentina, China, the Czech Republic, Denmark, Germany, Israel, Mexico, Scotland and Switzerland. Two new manufacturing sites are currently being planned and built in the U.S. and in India. Ferring's facility in Saint-Prex, Switzerland, is a state-of-the-art, multi-purpose site providing additional production capacity with respect to Ferring's dry product range, as well as secondary packaging and distribution of all products.
Growth has been especially strong for the company, evidenced by its burgeoning portfolio of biopharmaceutical therapies and the necessary rise in capacity required to make and supply its products worldwide. But like any company, one of the toughest things to do is manage such growth effectively—something made even more complex because of the highly regulated environment that frames the entire pharmaceutical industry and its manufacturing processes. Ferring, like most biopharmaceutical companies of its age and legacy, supported its batch processing production cycle with a paper-based batch record- keeping system. This system of record keeping also formed the foundation of the company's Quality Assurance/Quality Control (QA/QC) regime, which is fundamental to the company's ability to comply with global regulators including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Growth Presents Challenges
It guides the user to the desired destination, finds the shortest trip, alerts one to dangers and provides feedback in real time." Ferring Pharmaceuticals' Jerome Repiton on why the company's electronic batch record system acts much like a car's GPS.
As Ferring's market success drove its growth, it became clear to the company's executive managers that more had to be done to improve operations, accelerate its time-to-market, enhance its quality and compliance regimes and give its employees sharper tools to manage quality and compliance all the more accurately across its international supply chain. The solution, the company felt, was to implement an integrated manufacturing execution system (MES) beginning with an electronic batch record (eBR) application. In pharma, batch records and process transparency are critical elements of regulatory compliance and managing its products' "time in chain."
Jerome Repiton, Ferring's associate director of its Lean Six Sigma program, offered RSTechED attendees a table revealing that manufacturing lead times for the pharmaceutical industry were between 120 and 180 days—a long period relative to other industries due to the demands regulators place on drug producers. Regardless, says Repiton, Ferring's lead time was "very long," especially relative to its competitors, and the company felt that implementing an eBR and integrating it into a contemporary MES would "help us eliminate steps in the chain."
Repiton explained that within the frame of product manufacturing lead times, Ferring's manufacturing step is one of the shorter elements of the process. What takes the most time is the QA/QC qualification testing and review that can take weeks and often occurs after the product is made: "You can't manage a product without information, and compliance is impossible without information," he said. The rub for Ferring was that all of its batch information was generated via paper-based methodologies, embedded in standard operating QC procedures that extended the time from batch manufacture to release to some 44 days or more. In 2010, Ferring began its journey by implementing at its premier facility in Saint-Prex an eBR/MES solution based on FactoryTalk PharmaSuite from Rockwell Automation.
eBR as GPS
According to Repiton, paper-based systems are full of "hitches," and no matter how well-organized a paper-based system might be, it could never deliver the real-time process transparency Ferring needs to manage its supply chain effectively. "An eBR solution," said Repiton, "is the GPS of manufacturing operations. It guides the user to the desired destination, finds the shortest trip, alerts one to dangers and provides feedback in real time."
Repiton explained that Ferring understood that eBR was the key to process transparency. If one has process transparency, he said, one can understand process trends in the same time frame and know immediately if there has been an excursion that might affect quality. With technology providing process data from Rockwell Automation that is characterized by the batch recipe—the "destination" in Repiton's GPS analogy—any deviation becomes known virtually instantaneously via the application's dashboard. "When you work with paper," noted Repiton, "you have to wait for someone to review the paper." Armed with real-time process information, qualified personnel can conduct batch quality review during manufacturing rather than after and manage by exception: "If nothing's wrong, then it is OK to press the button," said Repiton.
For Ferring, implementing FactoryTalk PharmaSuite was both a process quality and quality assurance process improvement program. Working with Rockwell Automation, Ferring is now able to track "time in process," and that includes time spent in QA/QC review. According to Repiton, with FactoryTalk, time in process has been essentially halved—a dramatic improvement and one of the primary goals of the whole endeavor. Since the eBR/MES program began in 2010, the number of batches processed by the company has jumped from 7,000 to 11,000; a 56% leap in just five years, accomplished, said Repiton with the same amount of staff, "representing a real return on investment."
With FactoryTalk well implemented and pervasive process data available to key operations, Repiton said Ferring created a solid basis to integrate the system with its information technology infrastructure, including laboratory information management and enterprise systems, to provide an MES that truly supports the organization's compliance and competitive agility goals. As far as the total solution is concerned, Ferring has plans to roll it out across its international operations and to its new facilities in India and the U.S. Characterizing it as an operational excellence project, Repiton concluded that Ferring is much better equipped to cope with the complexities associated with biopharmaceutical manufacturing and to proactively comply with demanding regulators around the world.