4 BioPharm International
®
Manufacturing and Facilities eBook 2023 www.biopharminternational.com
M
icrobial 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 prod-
uct 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 ster-
ile processing conditions. This sterile process aims
to significantly minimize the presence of particulate
and microbial contamination that could have detri-
mental effects on patient health.
Sen sit ive produc t s, such a s adva nced t herapy
medicinal products (ATMPs)—including gene ther-
apies, cell-based therapies, and tissue-engineered
products—often rely on parenteral delivery, as they
degrade within harsh acidic environments such as
t hose found wit hin t he stomach. Wit h 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).
T h is market va lue increase ref lects t he grow ing
interest in t hese t reat ments t hat address un met
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 rap-
idly, 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 man-
ufacturing 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.
Meeting sterile processing regulations
Maintaining sterile integrity is essential for therapies
that are injected into the body, such as ATMPs. To ensure
De-Risking Sterile
Manufacture with SUTs
Ben Wylie,
head of Product
Management and Marketing,
ChargePoint Technologies
Single-use technologies provide a barrier between operators and drug
products, allowing for sterility and personnel safety in manufacturing.
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