Implementing new information technologies into existing operations often takes on an air of Dickensian drama. Though decidedly not the French Revolution, two prominent companies were experiencing tough times: One challenged by managing quality to keep pace with rapid growth, and the other challenged to achieve transparency across a massive global supply chain while managing all of its complexity. Information technologies are revolutionizing Pharma operations, and attendees of Rockwell Automation’s recent user group and continuing education conference RSTechED 2014 were treated to case studies from the front-line managers of two prominent Pharma industry players — agile, competitive biotech Ferring Pharmaceuticals and world-class heavyweight Pfizer.
FERRING'S A PIONEER
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, says the company, in the United States and in India. Ferring’s headquarters 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.
PFIZER SEEKS KNOWLEDGE
For those working to manage geographically dispersed manufacturing assets like Pfizer, the path to operational “truth” is paved with information, that is, all the data streaming from its production equipment’s control systems and associated devices. For most enterprise, especially large complex drug manufacturing organizations, obtaining operational knowledge of its production assets is often an incredible challenge.
At $51.6 billion in revenue, global pharmaceutical powerhouse Pfizer is an undisputed industry leader. Operating in 175 markets and fielding 56 manufacturing sites, Pfizer provides consumers with a wide range of medicines and other therapies “from Advil to Zithromax,” explains José Medina, Pfizer senior analyst and intelligence manager, describing his company’s 20-location VisionPoint rollout. Characterizing the company’s product portfolio, Medina says in 2013, 10 were responsible for greater than $1 billion in sales, among them a little blue pill that most will recognize and that millions of men keep by their bedside.
GROWING STRONG AT FERRING
Growth has been especially strong for Ferring, 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 Medicine’s Agency (EMA).
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.”
A CHALLENGE AS LARGE AS PFIZER ITSELF
A company the size of Pfizer has enormous challenges, says Medina, largely due to its complexity, due mostly to the fact that it manufactures pharmaceuticals, and not just one kind, but several — both patent protected like Viagra, and biologics — as well as over-the-counter medications which have an entirely different economic/production model dictating their profitability. Regardless, since the introduction of the U.S. Food and Drug Administration’s “Pharmaceutical GMPs for the 21st Century – A Risk-Based Approach” 11 years ago, the pharmaceutical industry has been faced with a regulatory regime based on Good Manufacturing Practices (GMP). In his article “Coming of Age” (Pharmaceutical Manufacturing, April 2013) author Angelo DePalma, noted “GMPs for the 21st Century have profoundly influenced how drug companies manage risk, particularly but not exclusively with regard to manufacturing. The risk-based approach becomes particularly challenging given the backdrop of merger and acquisition activity and a heavier reliance on outsourcing for manufacturing and R&D. For manufacturing, this means negotiating the moving targets of productivity and supply chain demands.”