While the research and development (R&D) of a medicine is under way, a parallel process is undertaken to develop the manufacturing process and build manufacturing capacity – an often-overlooked part of a medicine’s lifecycle. As the R&D process progresses and researchers get closer to a potential successful treatment, companies must make the transition from manufacturing small exploratory batches of experimental medicines used in clinical trials to safely and efficiently manufacturing a medicine in mass quantities for the public, and they must develop the distribution system to get the medicine to patients. This includes:

• Establishing a robust manufacturing supply chain;
• Building the capacity to manufacture sufficient quantities of a medicine for the patients that need it;
• Developing and implementing supply chain management plans focused on quality controls related to every aspect of manufacturing and efforts to ensure continuity in manufacturing; and
• Obtaining the appropriate regulatory approvals for any new facilities needed to manufacture the medicine. 

Setting up the manufacturing capacity and all the pieces that go with it is a complex and lengthy process. Building a new manufacturing facility, for example, can cost up to $2 billion and take 5 to 10 years before it is operational, including the time and costs related to comply with various regulatory requirements. Expanding existing facilities and transferring a single product to a new manufacturing site isn’t any simpler. It requires process transfer and scale-up, validation, stability protocols and regulatory filings, which can take several years. As of April 2023, biopharmaceutical companies and their suppliers operated 1,580 production facilities across the country, in 48 states and Puerto Rico. Further, nearly 20% of these new facilities are manufacturing active pharmaceutical ingredients (APIs), which are the ingredients that produce a medicine’s intended health effects.

Over decades, biopharmaceutical manufacturers have carefully built these robust global supply chains to ensure patients in the United States and around the world have ongoing access to medicines. The industry is committed to ensuring a safe, stable and secure supply chain, which requires a significant investment in time and resources and ongoing coordination with the U.S. Food and Drug Administration and other regulatory bodies to help prevent and mitigate potential shortages or other disruptions.