IT Management / Software

Pharma’s Search for Operational Truth

Integration of control and business information technologies are opening new windows of enterprise transparency

By Steven E. Kuehn, Editor in Chief

As with any contemporary, complex manufacturing enterprise, information technology (IT) is a key, critical element crucial to effective and efficient operations. This is especially true for Pharma and Life Sciences. Of course it is, just ask any traditional IT operative in your organization; they’re sure to tell you the whole place would come to a screeching halt without their expert guidance and technology. Pride aside, it’s more or less fact. The digital age has introduced much in the way of game-changing technology to the “business” side of the house, including fundamental protocols, pervasive enterprise resource planning (ERP) platforms, and all those familiar, perennial business applications. Further, the exigencies of business operations demanded ever-more massive data-handling infrastructures, which is now outsourced and the engine that drove the rise of the cloud. 
Manufacturing engineers also embraced the computer age and within just a few decades industry embraced the notion of computer-integrated manufacturing (CIM) and transformed its myriad analog, hard-wired and manual control systems into a networked ecosystem of operational technologies (OT), that is, distributed digital control networks, automation and sensing to help better understand manufacturing and processing operations. It was only natural to begin to see the possibilities of connecting all the data and information coming from these rich fields. In a recent Smart Industry magazine editorial, Peter Martin, president of Schneider Electric related this bit about the rise of CIM in the 1980s: “We had the idea that if we took networks and tied all the computers we had together, something good was bound to happen.”

That was the vision, but Martin’s comment reveals much because it captures the magical thinking that (at the time) accompanied this technological innovation. Colleague and veteran industry observer Keith Larson, editor of sister publication Smart Industry explained that in spite of good intentions, at the outset “Integration was hard; integration was time-consuming; integration was expensive. And, once achieved, these custom links were brittle and maintenance-intensive too. As a result, only those integration projects deemed essential to operations or those that cleared a very high return on investment bar were undertaken — and only then by the enterprises with the resources to fund them.”

The dream became more a waking nightmare to some; integration and communication across domains was difficult at best and those who embarked on this path found that the initial investment was only one element of an increasingly expensive proposition that consumed operational resources and budgets, ultimately putting extreme pressure on its overall value proposition.

Networking production assets, monitoring critical and operating state process, and generally getting data flowing across manufacturing operations was hard enough, and the notion of deriving business value by integrating and sharing this data with the business systems and analytical platforms in the C-suite really did seam like magical thinking, and kept the two “technocracies” if you will, entrenched in their respective kingdoms, managing an uneasy detente.

CONVERGENCE
For many a year, IT and OT disciplines ran along parallel tracks, introducing advancements and features that served the interests of their respective groups. Few in either camp were focused on delivering the potential of these technologies beyond their traditional roles; even after some 35 years the industry is still talking about the divide. But the gap is closing, and judging by the high level alliances between titans like Cisco, SAP, Oracle IBM and automation giants like Emerson, Rockwell, Siemens, Werum and others, OT and IT convergence is their collective solution to managing the incredible complexities associated with the global pharmaceutical manufacturing enterprise, and the cloud is where they all are convinced this utopia can be realized.

In 2015 the technical and economic barriers to OT/IT convergence are falling away, creating much stronger, more robust, reliable links. Perhaps most important has been the increasing amount of computing power end devices like sensors and controllers have built in — in other words, the availability of increasingly “smart” controlling and sensing technologies with that are capable of crunching incredible volumes of data at the edge of plant networks. Similarly, the industry developed open integration and communication standards that have dramatically improved the efficacy of the links demanded of real-time highly integrated OT networks.

The economics of these devices continue to improve as price and functionality follow inverse curves and connectivity via open, standard protocols and wireless networks make integration with legacy systems even more financially and administratively feasible. Notable also is the fact that the costs of computing have fallen dramatically as well.

As mentioned, information technologists turned to the Internet to provide the means to manage and transmit data globally. The cloud was born. And the Industrial Internet of Things (IIOT) as Smart Industry spins its core ethic. Fundamentally, the IIoT is an overarching term to describe the Internet Protocol (IP)-based communications infrastructure that connects uniquely identifiable electronic devices via the web.

As a result, all industry — including pharmaceutical manufacturing — has access to an expanding range of converged, integrated technologies, connected and available to move and exchange data to and through applications that by function and design, are supposed to reveal operational “truth” and deliver it to the organization in a timely relevant fashion.
What’s to be done with all this operational truth? Well, that is the big question, now isn’t it? Pharma is embracing this convergence, but like any industry that begins to adopt contemporary technologies, that uptake is accomplished in fits and starts, trials and pilots, in a fashion that serves the organization’s assets as they exist and what they aspire to be. It’s an enormous challenge to bring the business value from all the connectivity that the technology and its developers promise.

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 the challenge.

A company the size of Pfizer has enormous challenges, 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.

It’s within this context that Pfizer has steadily structured and refined its manufacturing assets to support and implement GMPs integrating them into Pfizer Global Supply (PGS), the internal organization tasked with supplying the company with the products it develops and markets around the world. According to Pfizer Global Supply’s John Kelly, VP sourcing & network strategy and transitioning operations, “Pfizer Global Supply [is] a critical element of Pfizer’s success … We’ve always been a very vision-focused organization … Our purpose is to supply quality products for a healthier world.”

Fulfilling PGS’s mission and vision, as Kelly succinctly described, is entirely dependent on managing its production assets as efficiently as possible, a task that is even more dependent on the operational truth derived from the Enterprise Manufacturing Intelligence (EMI) it derives from the vast amounts of data streaming from its control devices and production and processing equipment and the subsequent reports provided to PGS executive management. Pfizer continues to rely on Rockwell Automation’s platforms and applications to bring the benefits of connected operations to the organization.

SEGMENTS, VENDORS DRIVING CONVERGENCE
With operational excellence so critical to managing Pharma manufacturing risk, the industry’s vendors continue to respond with technological collaborations that foster integration and enterprise connectivity. For instance, GE Healthcare’s Life Sciences business and Emerson Process Management announced a collaboration aimed at increasing productivity and improving the process efficiency of biopharmaceuticals such as monoclonal antibodies and vaccines.

According to a recent press release, the two companies will collaborate to integrate Emerson’s distributed control system with GE Healthcare’s enterprise offerings and start-to-finish technologies for the global biomanufacturing industry. According to the companies, biopharmaceutical manufacturers are increasingly looking to automate production processes, driven by the industry need to increase efficiency and reduce costs.

GE Healthcare’s Emmanuel Ligner said: “Healthcare providers and the biopharmaceutical industry are facing enormous pressures. Emerson and GE share a vision that an integrated and automated approach to manufacturing has the potential to help drive improvements in production efficiency of these life-saving medicines.” These vendors believe that the combination of Emerson’s automation technologies and GE’s FlexFactory offerings will support “more predictable processes that eliminate unnecessary work, which translates into a reduced time to market for our customers.”

A CMO INTEGRATES
Leading mid-sized contract manufacturer Losan Pharma is implementing Werum’s PAS-X to support the production of solid dosage forms at its main plant in Neuenburg am Rhein, Germany. According to Werum, Losan is implementing a full-scope MES system that includes warehouse management and fully integrated Track & Trace capability.

Losan specializes in contract research and manufacturing of innovative solid dose forms for an enviable list of international pharma and biotech clients. Werum says its platform will be implemented out of the box in several stages as a full-scope MES interfaced with the Infor Blending ERP system. “The integrated Track & Trace functionality ensures a consistent flow of information from the ERP to the automation level. So we do not need an additional third-party product for serialization,” says Dr. Marco Klingele, head of administration, Losan Pharma GmbH. “PAS-X will help us to significantly increase the efficiency and quality of our processes and provide our customers with even better products in an even shorter time.”

SPENDING ON IT
Recently Pharmaceutical Manufacturing attempted to gauge spending priorities of those in operational roles by asking: “What sort of systems (associated with process/manufacturing operations) is your company investing the most capital dollars in on the shop floor?” Among the 121 responders, 47 percent indicated “Higher speed, higher-capacity processing systems and equipment to meet increasing product demand or new product production.” About a quarter, 24.4 percent, chose “Adding process analytical technologies to existing lines to understand critical processes better.”

In our 2015 study, fewer respondents seem to be working at organizations making investments in informatics and data managing technologies. Just 14.8 percent chose “Production-related informatics and process data acquisition and handling platforms.” Lest we judge too harshly, these folks may be working for companies that already invested in IT and their responses indicate this segment of IT spending is no longer a priority.

“Industry trends,” we asked, “reveal that to better manage the costs and expenses associated with drug manufacturing operations, managers are looking for innovative ways to shift from traditional capital expenditure models and turning to operational expense models in pursuit of operational improvements and new or extra capacity. Most of the converged offerings by the major players offer a host of opportunities to allow clients to take advantage of OpEx balance-sheet opportunities. Do Pharmaceutical Manufacturing’s readers agree that this is a strategy worth pursuing?” Two-thirds (63.8 percent) said yes, it’s worth pursuing.

For those who answered in the affirmative we asked, “Where are manufacturing-related operating expense dollars being applied?” and asked them to please pick all that apply. “Information Technology systems and infrastructure (Outsourced IT providers), was the most popular choice at 41.7 percent.

While the results of the study provide only a snapshot how the industry is spending its money, it’s clear that the industry continues to pursue operational excellence via this technological channel. But the benefits the community of technological vendors purports this connected utopian omniverse will deliver is still being viewed with a certain amount of reticence and skepticism by manufacturers of all stripes, including Pharma. But operational experience will win out and that’s being gained every day. The connected enterprise is a technological reality now, and likely standard operating practice for years to come.

 

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