- Olon Group is constructing a High Potency Active Pharmaceutical Ingredient (HPAPI) suite in Concord, Ohio, adding to their capabilities in handling HPAPI.
- The suite will expand Olon’s capabilities to serve clients developing innovative therapies for cancer, rare diseases, and other challenging therapeutic areas.
- The new facility will benefit existing clients and pave the way to collaborate with a wider range of clients and explore new therapeutic indications.
Olon Group, a leading API supplier and contract manufacturer, has announced the construction of a state-of-the-art High Potency Active Pharmaceutical Ingredient (HPAPI) suite in Concord, Ohio. This suite is set to significantly expand Olon’s capabilities to serve clients developing innovative therapies for cancer, rare diseases, and other challenging therapeutic areas.
“This project is set to redefine the pharmaceutical landscape and reinforce Olon’s commitment to innovation in the US,” stated Giorgio Bertolini, Senior VP R&D Olon Group. “Our High Potency API suite is not just a facility; it’s a gateway to new possibilities.”
The suite will operate for materials with an Occupational Exposure Limit (OEL) of <1 µg/m3 (OEB5, SafeBridge 3), a level of containment essential for working with materials classified as highly potent, especially in the realm of anti-cancer drugs. As additional safety data becomes available, the site can adapt protocols, allowing scale up for 1-10 µg/m3 OEL (OEB4, SafeBridge 3A) or lower bands into the pilot plant.
Robert Poe, CEO of Olon USA, commented on the importance of safety in handling these potent molecules. “At Olon, we recognize that many small molecules in development today are designed to target cancer cells. These molecules are often incredibly potent, and until additional safety data is available, must be approached with caution,” he said.
The new facility will not only benefit existing clients but also pave the way for collaboration with a wider range of clients and explore new therapeutic indications. “Olon’s new high potency API suite is a significant investment in our company’s future and its commitment to providing its clients with the best possible services and support,” concluded Bertolini.
For more from Olon, listen to recent podcast interview with Andrea Conforto VP for Biotech and Roberta Pachera, VP Small Molecules.
Olon Group are a sponsor of CDMO Live, the new online event for partnering with contract manufacturers in June 2024. Register your place here.
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