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Single-use technologies provide a barrier between operators and drug products, allowing for sterility and personnel safety in manufacturing.
Microbial contamination poses a risk to patients—especially in the case of drug products administered parenterally—and must be addressed through quality control measures in manufacturing to ensure product safety. Parenteral products are injected directly into the body, bypassing the gastrointestinal tract, one of the body’s natural defences. Therefore, these treatments must be manufactured under strict sterile processing conditions. This sterile process aims to significantly minimize the presence of particulate and microbial contamination that could have detrimental effects on patient health.
Sensitive products, such as advanced therapy medicinal products (ATMPs)—including gene therapies, cell-based therapies, and tissue-engineered products—often rely on parenteral delivery, as they degrade within harsh acidic environments such as those found within the stomach. With projected growth from $10.37 billion in 2023 to $23.58 billion in 2028, the ATMP market is expected to increase at a compound annual growth rate (CAGR) of 13.2% (1). This market value increase reflects the growing interest in these treatments that address unmet needs, with a particular focus on curative solutions for chronic diseases. Their reliance on sterility for safety demands robust aseptic processing methods, the market for which, as a result, is also growing rapidly, with an expected CAGR of 6.13%, from $95.63 billion in 2023 to $173.37 billion in 2033 (2).
One solution aiming to reduce the risk of microbial contamination works by introducing closed manufacturing methods, which can be achieved with single-use technologies (SUTs). This means that the product is closed off from the outside environment and transferred between sterile systems.
Ben Wylie, head of Product Management and Marketing, ChargePoint Technologies
eBook: Manufacturing and Facilities
When referring to this article, please cite it as Wylie, B. De-Risking Sterile Manufacture with SUTs. BioPharm International’s Manufacturing and Facilities eBook (November 2023).