Olon Group announces the construction of a cutting-edge High Potency API suite.
A GMP High Potency Active Pharmaceutical Ingredient (HPAPI) suite, currently under construction at the Olon USA site in Concord, Ohio, the center of excellence for early development of APIs within the Olon Group. This adds to the significant commercial scale expertise and capabilities of the Segrate and Rodano sites near Milan, Italy, and it is part of an important growth of capabilities for handling HPAPI in the group where the company has invested overall around 40 million Euro in the last few years.
“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 “Our High Potency API suite is not just a facility; it’s a gateway to new possibilities. Engineered to meet the most stringent safety standards for R&D and GMP processes, this suite will operate for materials with an Occupational Exposure Limit (OEL) of <1 µg/m3 (OEB5, SafeBridge 3). This level of containment is essential for working with materials classified as highly potent, especially in the realm of anti-cancer drugs, where safety is paramount. This is highly integrated with the already existing capability in our Italian sites such as Rodano, to produce highly potent APIs in large-scale product batches ranging from 30 to 150 kg. Today we are one of the few API suppliers to offer the range of specific integrated capabilities necessary to support the customer from the first clinical phase up to industrialization, regardless of the quantity of product needed and batch size required and regardless of the ongoing molecule 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. As additional safety data becomes available, the site can adapt protocols, accordingly, allowing scale up for 1-10 µg/m3 OEL (OEB4, SafeBridge 3A) or lower bands into the pilot plant using continuous liner and the portable filter dryer which is rated to OEB5.
While the new facility will undoubtedly benefit our existing clients, it also paves the way to collaborate with a more extensive range of clients and explore new therapeutic indications. For startups and academic ventures in the early stages of drug development, the path forward can be daunting. Olon’s High Potency API suite aims to simplify this journey by providing the necessary expertise and guidance as the company support smaller clients develop the road map for their program, helping optimize processes, prioritize safety, and streamline the path to clinical trials, ensuring that groundbreaking ideas become reality.
“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. The suite will allow Olon to support a wider range of clients and therapeutic indications, helping to bring new and innovative therapies to market faster and more efficiently” stated Giorgio Bertolini.