• January 24, 2024

In the ever-evolving world of pharmaceuticals, Olon continues to push the boundaries of what’s possible. We’re excited to introduce a groundbreaking initiative – our 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 more than 40 million Euro in the last few years.

Olon has embarked on an ambitious journey with the construction of a cutting-edge High Potency API suite. 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, gene therapy, and other challenging therapeutic areas.

The Gateway to New Frontiers

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.

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. 

The High Potency API suite will provide a secure and self-contained environment for working with these materials, ensuring the safety of our chemists and staff as they develop the synthetic process or manufacture your pre-clinical/toxicology and clinical grade materials. As additional safety data becomes available, we can adapt our 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, or if the program continues to be rated at the higher banding level we can tech transfer to one of other Olon sites for larger scale manufacturing.

Olon has also partnered with Extract Technology for the build of the isolator to ensure that the suite meets the highest safety and quality standards.

Expanding Horizons & Empowering Innovators

Our suite is not just about enhancing our current capabilities; it’s about opening up a world of opportunities. While it will undoubtedly benefit our existing clients, it also paves the way for us to collaborate with a more extensive range of clients and explore new therapeutic indications. It’s a testament to our commitment to making a positive impact on patients’ lives.

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 we help our smaller clients develop the road map for their program. We help 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.

Seize the Opportunity

With the facility scheduled to be fully operational in mid-2024, the time to take advantage of Olon’s specialized services is fast approaching. If your company needs these critical capabilities, we invite you to reach out to Olon and initiate a conversation about your project. Together, we can harness the potential of our High Potency API suite to drive innovation in pharmaceuticals and bring life-changing therapies to the world.

For those attending the upcoming DCAT conference, be sure not to miss the chance to be among the first to learn more about Olon’s exclusive services from the Olon Executive Team. Capacity is limited, and demand is expected to be high. The future of pharmaceutical innovation is within reach, and Olon is leading the way. Don’t miss this opportunity to be part of a transformative journey. Get in touch with Olon today!