Whether it’s single-use systems, continuous manufacturing or modular design, accepting and adapting new technology is critical in the new pharma reality where agility and flexibility reign supreme.
The healthcare sector now requires increasingly specialized products used by a small groups of patients. Regulatory authorities support this trend by offering accelerated approval processes for these popular drugs. This new method of pharma manufacturing, coupled with an increased focus on reducing manufacturing costs and unpredictable demand for different products, demands more flexible and agile facilities. A broad range of tools must be activated to meet this specialized facility need, such as single-use technologies, continuous manufacturing, a modular approach and new operational models.
As new products are approved much faster, the future winners of the manufacturing race are building facilities where product change-over is done in days or even in hours.
The new pharma reality
The pharmaceutical landscape has changed significantly in the last decade. Previously successful facilities are becoming outdated, costing companies dearly in terms of both finance and compliance. Players in the new pharma reality have to predict future demands due to increasing competition from generics and biosimilars. They face pressure on drug prices and reimbursement policies, and deal with the uncertainty of the local/global political situation and associated requirements. The old blockbuster products were mainly for big markets of traditional medicine. New products are approved much faster than just a few years ago, meaning the future winners of the manufacturing race are building facilities where product change-over is done in days or even hours.
Single-use systems for biopharmaceuticals
Nearly every week, suppliers announce new solutions based on single-use technology. Though their origins are found in single-use bags for liquids, there has been a successful introduction of single-use bioreactors. Now the technology is spreading into all other aspects of modern manufacturing. The drivers for this growth are not only the cost of investments, but also the cost of flexibility, expansion capabilities and most importantly, reduced product change-over time.
Facilities that manufacture continuously often require less infrastructure, utilities, space, investment and staff and experience an improved utilization of the production facilities (24/7 operation vs 8 hours operation, 5 days a week). All aspects that support a more cost-effective operation. But regulatory authorities have latched onto another benefit of continuous manufacturing – increased quality. There is a significant regulatory push in the direction of continuous manufacturing, from both the United States Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA).
Another key technology supporting agile and flexible solutions is modular pharmaceutical facility design. Though this complex technology requires careful consideration, it offers advanced technologies that enable virtually out-of-the-box cleanrooms, utility buildings or even manufacturing facilities for continuous manufacturing. A combination of modular solutions and the many types of equipment that are available as "skid-mounted" solutions form a highly effective way of doing facility projects. This enables high agility and flexibility and, of course, shorter time to market.
It is possible to plan and design for flexibility, but the acceptance and adaptation of technologies supporting a more agile and flexible pharmaceutical manufacturing sector are critical to meet these future challenges. New technologies should be supported by a structured risk-based approach and calculated to cover the entire life cycle of a facility. With this tactic, it is possible for the pharmaceutical industry to meet the challenges of the new pharma reality.