Olon to Open New High Potency API Suite in US
Olon Group is building a state-of-the-art High Potency Active Pharmaceutical Ingredient (HPAPI) suite at its Olon USA site in Concord, Ohio. This expands the company's capabilities for handling HPAPI, with investments totaling around €40 million ($43 million) in recent years.
The new suite adds to Olon's other commercial-scale expertise and capabilities at the Segrate and Rodano sites near Milan, Italy.
“This project is set to redefine the pharmaceutical landscape and reinforce Olon's commitment to innovation in the US. The suite will significantly expand our capabilities to serve clients developing innovative therapies for cancer, rare diseases, and other challenging therapeutic areas” stated Giorgio Bertolini, Senior VP R&D Olon Group.
Olon's HPAPI suite ensures top safety standards for R&D and GMP processes, handling materials with an OEL <1 µg/m3. Integrated with its Italian sites like Rodano, it produces large-scale batches (30-150 kg) of highly potent APIs. Olon offers support from initial clinical phases to industrialization, regardless of quantity or development phase.
“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” commented Robert Poe, CEO Olon USA.
The High Potency API suite will provide a secure and self-contained environment for working with these materials, ensuring the safety of our operators and staff as they develop the synthetic process or manufacture your clinical-grade materials. Olon's HPAPI suite will also aid startups and academic ventures in early drug development by offering expertise, guidance, and streamlined paths to clinical trials, fostering innovation.
