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Cleanrooms-on-demand: a practical answer for fast-moving pharma?

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Jon Sewell, special projects manager (Aseptic Filling Program Lead), Origin, looks at the rise of cleanrooms-on-demand in the pharma manufacturing sector, the challenges it helps to overcome and whether this could become the future blueprint.

Key insights:

Sterile manufacturing is a highly complex and stringent area of production and requires expert skill sets, high capital expenditure and technologies.

At present, the global cleanroom market is estimated to be worth USD 5.0 billion by 2028. The electronics and semiconductor industry dominates the market with a 60 percent share, followed by the pharmaceutical industry. Emerging drug development strategies and therapeutic delivery models continue to prompt pharma to improve the economics associated with complex cleanroom spaces, including exploring an on-demand model.

The “as a service” (AAS) business model has become widely adopted by IT professionals as part of digital transformation strategies. And this new service-centred model is now filtering into the pharmaceutical industry, allowing manufacturers to control value creation, avoid backlogs with CDMOs and remain agile.

By using services like cleanrooms on an on-demand basis companies can rapidly enter the manufacturing stage or fail fast and pivot accordingly.

The distinct standards of a cleanroom environment

Whilst its name is self-explanatory, there are numerous criteria that need incorporating into an environment for it to qualify as a cleanroom.

The design and testing stages revolve around the principles of ISO 14644, consistently complying to distinct standards in terms of the quantity and size of particles per volume of air.

In accordance with ISO 14644-1, an ISO 1 environment is the cleanest level possible, and ISO 9 is at the other end of the scale, although it will still be significantly cleaner than a normal production room.

The most common classes of cleanroom are ISO 7 and ISO 8, which must also meet industry-specific and regional standards such as EU GMP guidelines A, B, C and D. Pharmaceutical products are typically Class C (requiring an ISO 7 cleanroom) and Class D (ISO 8).

To maintain a compliant cleanroom, the air pressure within it must be higher than its ambient surroundings. The result is a unidirectional outgoing airflow, with an incoming airflow that’s strictly monitored by our advanced systems.

The air that does enter the cleanroom is HEPA filtered, removing more than 99 percent of particles larger than 0.3 µm. Aside from controlling the particles, cleanroom engineers also perform temperature and humidity control to keep the production process stable and reliable.

Usually, designing, building and opening a cleanroom facility can take anywhere between a year and five years to complete. As a specialised area of healthcare manufacturing, cleanroom and sterile filling facilities require specialised staff to ensure these complex environments and machinery are run efficiently and in accordance with strict regulations. This can delay timelines given the skills shortages in science, technology, and engineering.

These are some of the reasons why the cleanroom-on-demand model is gaining momentum.

The issues cleanrooms-on-demand can help to solve

The “as a service” (AAS) business model is an emerging business model that shifts the customer - supplier relationship to a non-ownership basis.

Testing, diagnostics and manufacturing capabilities were pushed to the limit during the COVID-19 pandemic. It brought several issues within the global pharma supply chain into sharp focus, including a lack of manufacturing space, the value of speed to market and the vital importance of agility and flexibility.

Now the pandemic is largely controlled, it’s an important opportunity to review and debate the future of domestic and international pharma manufacturing infrastructure – including cleanrooms facilities. 

The build vs broker dilemma is one pharma companies are likely to have experienced prior to the pandemic and it has since intensified. Life sciences companies of all sizes typically have had to choose between building their own facilities at high cost or outsourcing their work to CMOs/CDMOs who sometimes have long waiting lists.

To continue to excel and lead the way in global scientific advancement, pharma must build and evolve its cleanroom capabilities to create quality, safe and compliant products but on a more flexible basis. A more hybrid model, allowing access to cleanroom facilities when they are needed without the need for facility ownership, could be the answer and where the market is headed.

Cleanroom capabilities for drug development and manufacture aren’t reserved exclusively for big pharma with large production runs. Businesses who are relatively new to the healthcare sector or are still in the start-up stage have a lot to gain in leveraging cleanroom facilities for small product runs too. And cleanrooms-on-demand (COD) can serve several customer needs, from clinical trials, mass manufacturing and packaging production.

For both biotech start-ups through to big pharma, COD can help to eliminate capital expenditure, enhance IP protection, provide greater control of production schedules and increase speed to clinic or market.

The future of cleanroom infrastructure

The current market for COD is small globally, with Azzur Group being first to market with multiple sites in the U.S. The company recently announced Moderna as an anchor client in its ready-to-use cleanrooms located in biotech clusters throughout the US. It also has plans to expand its COD infrastructure further in 2024.

Over the next 5-10 years we can expect to see the COD model become more commonplace, and slot into the wider market for sterile manufacturing environment alongside in-house and CDMOs.

However, as the COD market grows it may well run into some of the challenges facing established and traditional players, most notably the shortage of specialist skills which may slow its expansion and supply chain delays for equipment.

We can also expect to see more cleanroom operators offer more flexible services through modular configurations to meet the ever-changing needs of customers and respond to the ‘unpredictabilities’ of project execution. These are engineered to accommodate virtually any commercially viable floor plan both horizontally and vertically.

After all, one size never fits all.

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