Pharmaceuticals

In the pharmaceuticals and biotech industries, projects and manufacturing are often secondary to discovery and marketing. Most pharmaceutical companies have not examined the value of implementing an excellent capital project delivery system. IPA has found that, across all process industries, a Best-in-Class project system delivers projects that are 10 percent to 30 percent less expensive and 10 percent to 40 percent faster than the industry average. The pharmaceuticals industry, like other industries, is poised to reap the benefits that a Best-in-Class project system can deliver.

The pharmaceuticals and biotech industries execute a wide variety of projects from production facilities to laboratories to site utilities and infrastructure. In this complex environment, the industry is challenged to develop capital project delivery systems that can effectively manage varying priorities, functionalities, and regulatory requirements.

For primary pharmaceutical projects―including those for bulk chemical, bulk biopharmaceutical, and biotechnology facilities―the priorities are often to deliver a high-quality facility on a schedule that is constrained by market demands as well as by regulatory needs. Secondary process projects―such as those for tableting, coating, and sterile filling facilities―often employ newer technologies in the areas of mechanization, containment, etc. For pharmaceutical manufacturing facilities, the constructed facility must meet current Good Manufacturing Practices (cGMP) regulations and comply with FDA or other regulatory authority requirements. The typical pharmaceutical project delivery system must have the flexibility to deliver market-driven or new-technology manufacturing-facility projects while cost effectively delivering infrastructure or “non-rush” projects.

IPA’s Experience

IPA helps pharmaceutical companies develop the flexibility in project systems and project implementation processes required to plan and execute all capital projects effectively. IPA has examined more than 9,000 projects from the processing industries, including approximately 500 pharmaceuticals projects. We understand, through analysis and quantitative measurement, the project procedures that are most effective for any combination of business demands.

IPA'S Pharmaceutical Projects Database

Our detailed and carefully normalized Pharmaceutical Projects Database covers all types of industry capital projects: from utilities and infrastructure projects to laboratories and manufacturing facilities. The database contains projects from pharmaceutical companies worldwide such as Merck, Eli Lilly, Sanofi Pasteur, GlaxoSmithKline, Schering-Plough, Wyeth, Bayer, and Johnson & Johnson. Comprising approximately 500 projects, the Pharmaceutical Projects Database includes standalone facilities, add-ons, expansions, and revamps.

The database contains variables for each project that cover the entire project life cycle, from early planning and R&D through commissioning, qualification, and early operation. We have used these data to develop powerful statistical tools that enable us to compare pharmaceutical project performance in numerous areas. IPA analysts use these data and tools to evaluate project inputs and outcomes, and to benchmark project systems. In addition, IPA performs research to examine the key issues for pharmaceutical and biotech projects, such as project system responsiveness, commissioning and qualification best practices, and engineering costs.

Pharmaceutical and Biotech Research Consortium

IPA’s Pharmaceutical and Biotech Research Consortium consists of IPA member companies that have directed IPA to develop research that is specific to the pharmaceuticals and biotech industries. The consortium was established in 2005 with a 3-year research agenda that reflects the needs and priorities of the pharmaceutical industry with respect to capital excellence. IPA’s goal is to provide results that will add the most value to the pharmaceutical and biotech industry bottom line and to provide a competitive advantage to participants in the research program.

For more information, contact: Allison Aschman (+1 703-726-5338), Natalia Zwart (+1 703-726-5305), or Valerie Roma (+31 70 315 1078)