The biopharma industry is shifting toward advanced-therapy, medicinal products (ATMPs), such as cell and gene therapies, to treat chronic and rare disease indications. These therapies work by targeting the root cause of the disease, providing a potentially curative solution, and moving away from the need for long-term repeat dosage.
The trend is reflected in the market, which is predicted to increase at a compound annual growth rate (CAGR) of 13.2% from $10.37 billion in 2023 to $23.58 billion by 2028, according to Global Market Estimates. As this transition continues, the industry must re-evaluate manufacturing and supply.
Due to their sensitivity, ATMPs can degrade when exposed to harsh conditions such as those found in the gastrointestinal tract (pH and temperature). As a result, ATMPs often rely on parenteral delivery methods, bypassing the body’s natural defenses. Therefore, these therapeutics must be manufactured in high-performance cleanrooms to ensure sterility for patient safety. Assuring product quality and minimizing risks, cleanrooms help developers meet processing and regulatory requirements.
In the past, manufacturers have opted for stick-built cleanrooms, where components are constructed onsite using conventional materials (e.g., drywall) and techniques, building the facilities with what is now outdated technology. Recent innovation has enabled the move to modular systems with elements of the facility premanufactured offsite. The modules can then be seamlessly and quickly assembled at the desired location, with these modular systems having the ability to accommodate almost any configuration to address even the most challenging host buildings.
Using prefabricated components means quality is improved and on-site execution is accelerated to produce cleanrooms in less time. Such modularity also enables repeatability, as standard and compliant manufacturing facilities can be easily replicated as demand evolves or additional locations are required to serve the market. This significantly reduces the risks associated with ATMP manufacture, with a cleanroom that is predictable and designed to perform.
While meeting evolving regulatory requirements for efficacious and safe ATMP manufacture, modular systems also provide manufacturing flexibility, which is essential to meet complex needs such as increased patient involvement. Modular cleanrooms allow designers to harness reconfigurability and fit components into varied facility concepts. These systems can also be installed in geographic locations close to patient populations they serve.
An example of this is autologous cell therapies, where cells harvested from an individual patient or a donor are used to develop the treatment. This demands that a cleanroom be placed close to the user community to reduce patient burden. Focusing on access to national and regional healthcare systems and networks ensures that innovative drug products can be controlled and distributed to patients efficiently, thereby improving treatment outcomes. Patient cell materials also often have a short lifespan, posing associated operational risks that could affect commercial viability. Placing facilities close to patients helps mitigate such risks.
With the demand for increasingly complex therapeutics rising, the modular cleanroom space has already begun to experience significant growth. As the industry continues to develop ATMPs in 2024, leveraging modular cleanroom systems will become more commonplace, transforming and enhancing manufacturing and supply to swiftly bring novel therapies to patients.
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