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Can a Modular Approach to Cleanroom Technology Deliver Flexible Sterile Manufacturing Capacity?

Trista Hager, Vice President of Sales at AES Clean Technology, explores the challenges facing pharmaceutical manufacturers in expanding their cleanroom capacity to meet burgeoning market demand. She discusses how a modular approach to new cleanroom installation can help deliver the flexible sterile manufacturing infrastructure to stay ahead of industry needs.

The sterile pharmaceutical manufacturing segment has been expanding rapidly in recent years and is showing no signs of slowing down. Worth $899 billion in 2021, the market is expected to grow by more than 50% by 2028, reaching $1,358 billion by the end of the forecast period.1

Several drivers are responsible for this strong market growth:

• An increase in vaccine manufacturing needs: The successful development of several effective COVID-19 vaccines and the need to vaccinate an unprecedented number of people worldwide has led to increased demand for limited sterile manufacturing capacity. A significant investment in expanding this cleanroom infrastructure by national governments and pharmaceutical companies enabled the rapid roll-out of these vaccines. Since then, companies have begun exploring the potential of the messenger (m)RNA technology platform used in several COVID-19 vaccines to develop new products to tackle other viruses, such as influenza.

• A rise in the number of biopharmaceuticals in development: The biopharmaceuticals market is projected to surpass $566 billion by 2032, growing at a compound annual growth rate (CAGR) of 8.2% throughout the decade.2 This is a result of the rapidly rising number of new biopharmaceutical projects in the development pipeline, with 8,000 medicines currently in development, 74% of which are potentially first-in-class.3

• Advanced therapy medicinal products (ATMPs) on the rise: Alongside other biopharmaceuticals, ATMPs based on genes, tissues and cells are making up a growing share of the development pipeline. The market for contract development and manufacturing organisations (CDMOs) specialising in these therapies is expanding rapidly and is expected to reach $18.8 billion by 2030, growing at a CAGR of 18.8% over the next seven years.4

The reason all these developments are driving demand for sterile manufacturing is simple. Due to their sensitivity to degradation in the gastrointestinal tract combined with bioavailability challenges, the majority of these treatments must be administered by injection, rather than any other route of administration. Injection bypasses the body’s principal defenses against infection. As such, these therapies require sterile processing capacity when they are approved for the market to ensure they are safe for patients to use.

To meet the future processing needs of all of these therapies, CDMOs and pharmaceutical manufacturers are under increasing pressure to invest in their cleanroom infrastructure. Novel ways to build cleanrooms, such as a modular approach to design and construction, are becoming increasingly important to deliver this new capacity quickly and efficiently.