Large, vertically integrated pharmaceutical companies participate in the entire drug pipeline, beginning with drug discovery and clinical trials, through scale up, manufacturing, licensing, distribution and marketing. In addition to traditional therapeutics, their products can now include genetic therapies and molecular organic compounds that regulate biological processes or alter targeted cells.
When a new molecule or cell line shows promise in Phase I and II trials, these companies are prepared to move quickly. They typically do so one of three ways. Those with strong visibility into Phase I or II clinical results may choose to undertake a greenfield manufacturing project, scheduling completion to coincide with the drug’s FDA approval. Others may review existing assets throughout the world that might be re-engineered to produce the new product. A third option is to engage a contract manufacturer for production.
Their ability to identify the most efficient path to full-scale production is aided by inhouse engineering and construction organizations with knowledge of available systems, platforms and manufacturing processes. Not only can they move quickly to scope new projects, but they can also stop them quickly should research findings change.
How Big Pharma Facility Needs Are Changing
When retaining outside design and construction firms, pharmaceutical companies have traditionally sought experienced teams that can turn on a dime to execute against strict production deadlines and goals. The ability to scale up quickly and perform effectively remain key.
But a growing number of large pharmaceutical companies are now also seeking additional help as they embrace Pharma 4.0 and the digital transformation of their operations.
The impact of Pharma 4.0 is far-reaching, touching everything from the qualification and operation of facilities to their design and construction. Interconnected frameworks of resources, information systems and processes will enable companies to anticipate and address potential challenges across the drug development life cycle. The great promise of Pharma 4.0 is improved product quality, process control, quality and supply chain management.
Pharma 4.0 goes hand in hand with the Industry 4.0 concepts currently revolutionizing the manufacturing sector. With Industry 4.0, facilities themselves are also getting smarter. Increased access to real-time data throughout all stages of an asset’s lifecycle — from design through to construction and maintenance — can be leveraged to inform materials management, maintenance and other issues. Data from connected machines can also be analyzed to identify patterns and insights that enable life science companies to optimize building performance, save energy and lower production costs.
The intelligent buildings and systems will need to be designed for the more frequent changeovers and smaller batches that will be typical of new personalized therapies. The increased connectivity will also demand greater levels of cybersecurity protections as well.
Life science companies benefit from working with resources that can help guide them through the facility changes this transformation requires. While traditional life sciences architects, engineers and constructors will continue to play acritical role, the niche experience of professionals in cybersecurity, process controls and other Industry 4.0 segments can add significant value to the result.