Several CDMOs, including Lonza are expanding capabilities in the fill/finish space, which is likely to reach $12.5 billion by 2027.
According to a research report by Insight Partners, parenteral (injectable) forms are likely to overtake small molecules as the largest drug product market group by 2026. Additionally, the report said the market might reach $12.5 billion by 2027 said the report.
With more and more contract development and manufacturing organizations (CDMOs) amping up their fill/finish capacity, the market is determined to surge in the coming years. Moreover, in 2023, several CDMOs including Sharp, Agronaut, and Quotient Sciences have invested in building their fill/finish capacity.
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“We are seeing significant growth in the development and manufacturing pipeline, which is driving a surge in demand for drug product services. Considering the overall pipeline growth and trends within biologics, the fastest-growing pharma segment, there is an increasing demand for complex products,” Peter Droc, head of drug product services for Lonza told BioProcess Insider.
The purpose of the filling line is the sterile filling of antibody-drug conjugates (ADCs) at a commercial scale. Since ADCs contain a highly potent payload, the entire manufacturing and filling process needs specific containment strategies, which will be achieved through an isolator system, decoupling the ADC suite from its surrounding environment, and implementing dedicated wastewater management systems.
ADCs are complex bioconjugates typically used to selectively target cancer cells. They consist of a highly potent cytotoxic agent, stable linker and a targeting monoclonal antibody. The targeting antibody brings a unique ability to decrease systemic side effects on healthy cells, while maintaining selective efficacy to the resulting therapy.
Recently, Swiss-based CDMO Lonza, announced a filling line at the Stein site dedicated to an undisclosed partner. The unit is anticipated to open in 2027 will create 115 jobs.
“The build-out of a dedicated filling line for ADCs is driven by the need for a specific customer. Expanding the offering by adding a dedicated suite for antibody-drug conjugates also strengthens our ability to support the entire process of manufacturing bioconjugates for clinical and commercial supply,” said Droc.