Olon USA’s high-potency API (HPAPI) suite is designed to meet the complex needs of modern pharmaceutical development. With an advanced facility equipped to handle Occupational Exposure Band (OEB) 5 classifications, Olon USA is positioned to support research, development, and early-phase production of potent compounds. This capability allows us to safely manage the high potency of many cutting-edge therapies, including a large portion of anti-cancer drugs. As more small molecules in the pipeline target serious illnesses like cancer, the demand for HPAPI expertise and infrastructure has become essential.
Meeting High-Potency Requirements with Precision
Olon USA’s HPAPI suite is built to handle compounds with rigorous potency requirements. Our suite allows us to work with highly potent materials at safe exposure limits, down to 0.1-1 microgram per cubic meter (OEB 5). This high standard means we can partner on projects where active compounds must be carefully controlled due to their potential impact on both target and non-target cells.
Our focus includes anti-cancer medications, with about 60% of small-molecule drugs in development targeting oncology. The ability to manage high-potency APIs aligns with these needs, as these compounds often start out as high potency before the full toxicity profile is established. If a compound is later reclassified to a lower potency band, Olon USA can seamlessly handle the transition within the same facility, preserving time and resources.
From Early Development to Global Scale-up
One key advantage of Olon USA’s HPAPI suite is our ability to support early development through to later stages, backed by Olon’s extensive global network. For many clients, early-stage development can be challenging due to the unknowns surrounding potency and safety. With our facility in Ohio, we support small- to mid-scale batches for preclinical and clinical API. For larger-scale production needs, Olon’s sites in Italy provide additional support, including facilities that can produce HPAPI materials up to 8000 L reactors with OEB 5 capabilities and an OEB 6 facility for the highest potency requirements to support antibody drug conjugates (ADCs).
This capability expansion means our clients do not need to shift between providers as their projects scale. From small-scale initial batches to full commercial manufacturing, Olon USA and our global network deliver a seamless path forward for HPAPI development.
Supporting Oncology Drug Development
Olon USA’s capabilities in HPAPI manufacturing are particularly well-suited for oncology, where there is often a demand for both targeted treatments and more broadly applicable cancer therapies. We have a strong track record in this area, having contributed to the development of several oncology drugs that have reached commercialization. Our Ohio facility enhances our ability to expand into new oncology projects that require high potency handling from day one.
While many early oncology drugs require only small batch volumes due to the specificity of their indications, larger-scale projects involving more broadly applicable cancer treatments can quickly outgrow small-capacity facilities. With Olon’s HPAPI suite, we meet both these needs and can easily scale up to our larger European sites if required with responsibility of the technology transfer on us; ensuring that we can support our clients’ needs throughout the entire lifecycle of their program.
A Global Network of Expertise
The expansion of Olon’s HPAPI capabilities reflects our commitment to offering clients flexibility and security through a global network. Access to OEB 5 and OEB 6 facilities in Europe ensures that Olon’s clients are prepared for any potency requirement or scale. Additionally, Olon’s sites in India provide added capacity and expertise, allowing us to support clients with a diverse range of API needs on a global scale. This global network allows us to partner effectively with clients no matter where they are in the drug development process, with all sites able to maintain the same high standards of safety and quality.
Reach Out to Olon USA
Olon USA is ready to support high-potency API projects from initial R&D through large-scale production. Our team has the expertise, facilities, and global network to manage even the most complex API requirements. Reach out to Olon USA today to discuss how we can meet your HPAPI development needs.