At the product level, pharmaceutical companies are constant innovators, perpetually unveiling new and more powerful treatments for a growing range of ailments. When it comes to manufacturing, however, drugmakers are notorious for lagging other industries. (Just last year, The Wall Street Journal described pharmaceutical manufacturing processes as “dating to the days of the steam engine.”)
More specifically, pharmaceutical manufacturers have not been able to realize the benefits of Product Lifecycle Management (PLM) technology, unlike their counterparts in the discrete manufacturing world. There, PLM is a technology-enabled discipline that has connected every step in the product lifecycle, enabling radical improvements in product quality and reliability while dramatically accelerating innovation.
Contrast that integrated approach with the current paradigm in pharmaceutical manufacturing, where information systems are largely fragmented and manual processes remain common. Fortunately, that is about to change. Converging factors are finally pushing drugmakers to adopt a more modern approach — one destined to improve efficiency, enhance quality and empower innovation like never before. As in the discrete world, technology-enabled PLM will again be the key.
The seeds of discrete PLM took root in the 1980s, when Computer-Aided Design technology revolutionized the way goods, such as cars and electronics, were developed and commercialized by providing a digital definition of the product. That not only unified the management of product knowledge, but also allowed the product design to become the central, digital structure driving all systems — most notably, in engineering and manufacturing. CAD and 3-D modeling now form the core elements of PLM in the world of discrete products.
Since discrete PLM is rooted in the 80s, it is somewhat ironic that drugmakers remain stuck in that very decade in many ways. The core technologies, concepts and approaches to managing pharmaceutical product knowledge and manufacturing continue to be dominated by thinking that evolved some 30+ years ago. Central to that thinking is the regulatory requirement for “documented evidence,” a product is being made according to an approved process. The key word there is “documented.” While paper-based approaches to manufacturing processes have largely been supplanted by electronic systems, the paradigm is still very much document-based.
As a result, much of the data required to develop and manufacture new drugs — and even make critical business decisions — remains dispersed among disintegrated information systems. There are many disadvantages to this approach, including:
• Labor-intensive (and thus error-prone) processes
• Lack of accountability and standardization
• Difficulty maintaining a “single version of the truth”
• Risk of knowledge loss from one manufacturing step to the next.
Perhaps worst of all, after a batch is manufactured, it is impossible to extract execution data in a way that can inform process optimization and business decisions.
In the past, some technology providers have claimed to offer PLM capabilities for process manufacturers. The problem there has been that drugs and other process-based products cannot be designed using CAD applications — the technology at the heart of discrete PLM. Digital design tools for process manufacturers have historically been standalone applications that cannot integrate with other systems the way CAD does. As a result, so-called PLM solutions for pharmaceutical manufacturing have continued to perpetuate the same disjointed, document-based paradigm.
Finally, however, pharmaceutical companies appear poised for a massive paradigm shift — powered by true PLM technology. There are two primary reasons this transformative change appears inevitable. First, a confluence of industry trends has rendered current approaches unsustainable. Second is the long-awaited emergence of CAD-like capabilities for pharmaceutical manufacturers.
Among the industry trends, the most significant is the dramatic rise in outsourcing to CMOs. Pharma companies accelerate time to market and reduce production costs through these partnerships, but lose visibility into the critical details of product manufacturing — sacrificing accountability and control over quality management. There is also the challenge of technical transfers, accompanied by the risk of knowledge loss.
Even internally, companies can have trouble retaining core product knowledge in these times of increasing employee turnover. Related to this concept, growth by acquisition helps to maintain information silos.
Meanwhile, expectations for technology and information access have changed over the past 30 years in the consumer and commercial sectors. Archaic document-based systems do not meet those expectations, and cannot serve the needs of an industry increasingly populated by personnel raised in the digital age.
As these challenges mount, the foundational technology to enable true process PLM is finally emerging. At last, pharmaceutical manufacturers have their CAD equivalent — digital process design and simulation technology that integrates directly with existing systems including Manufacturing Execution Systems, Distributed Control Systems, data historians and even Enterprise Resource Planning systems.