Ferring Pharmaceuticals of Saint-Prex, Switzerland, 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 develops and sells pharmaceutical products based upon natural, pituitary-produced peptide hormones. Over the past few decades, the firm 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 being planned and built in the United States and India.
Ferring's facility in Saint-Prex is a state-of-the-art, multi-purpose site providing additional production capacity with respect to Ferring's dry product range, and 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. However, 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).
Challenges of Growth
As Ferring's market success drove its growth, it became clear to the company's executives 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 managers felt, was to implement an integrated manufacturing execution system (MES), beginning with an electronic batch record (eBR) application. In pharmaceuticals, 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 attendees at the 2014 Rockwell Automation TechED a table revealing that manufacturing lead times for the pharmaceutical industry were between 120 and 180 days — a long period relative to other industries because of the demands regulators place on drug producers. Regardless, says Repiton, Ferring's lead time was "very long," especially compared to its competitors. Managers felt that implementing an eBR and integrating it into a contemporary MES would "help us eliminate steps in the chain," Repiton explains.
He says 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.