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API supplier Olon has started construction of a new manufacturing facility in Milan, Italy, which will be dedicated to production of cytotoxic payloads and linkers for ADCs.
On May 30, 2023, Olon Group, a global API supplier, announced that it has begun construction of a new manufacturing facility at its Rodano site in Milan, Italy, which will be wholly dedicated to managing and producing ultra-potent compounds. These compounds are intended for use as payloads and payload-linkers for antibody-drug conjugates (ADCs).
Olon has invested €22 million (US$23 million) into the new facility, which will house an ultra-high-containment production line to produce high-potency and toxic products. The facility is expected to reach containment level occupational exposure band 6 (i.e., target occupational exposure limit 10 ng/m3).
The first phase of construction will involve the building of the payload research and development area, which is expected to be complete by the first half of 2024. The second phase will involve finalizing the production line by creating quality control and good manufacturing practice production areas.
Upon completion of construction, the new facility will house production, quality control, and R&D areas as well as auxiliary facilities, forming a complete, closed-loop system. This closed-loop system will include all steps of the ultra-potent compound production process—synthesis, isolation, drying, and analysis—all within an ultra-high-containment plant, according to a company press release.
“[A]bout 80% of the ADCs either approved or under development contains [these] type[s] of payload[s], such as dolastatins or maytansnoids, and there are also other highly strategic classes of cytotoxic payloads, such as anthracyclines, camptothecin, and calicheamicin,” said Giorgio Bertolini, senior vice-president R&D, Olon Group, in the release.
Source: Olon Group