Emerging pharma companies face a critical decision early in their journey: invest in internal infrastructure or partner with a contract development and manufacturing organization (CDMO). Partnering with a CDMO provides immediate access to development and manufacturing expertise without the financial and operational burden of building facilities from the ground up.
Olon USA supports startups at different stages of their strategy, whether at the point of just identifying the target molecule or advancing a molecule through Phase I and Phase II for potential out-licensing or preparing for commercialization. With end-to-end capabilities, projects can advance seamlessly from preclinical development through GMP manufacturing, with risk-mitigated and cost-free technology transfer to larger Olon Group sites when required.
A CDMO Built for Emerging Companies
While Olon is a global company with 14 sites, Olon USA operates with the agility and focus required by startups and emerging biotechs. The Concord, Ohio, site is structured to support small and mid-sized companies, ensuring that early-stage projects receive dedicated attention. Clients gain the experience of a global network while working with a specialized U.S. site built around development programs rather than large-volume commercial supply. For companies evaluating potential partners, see what pharma companies should look for in a CDMO to help guide the decision-making process.
Most of Olon USA’s revenue comes from emerging companies, making startups a central focus of operations. Projects are treated as long-term programs rather than isolated activities, with the same team supporting development milestones from initial batches through clinical readiness.
Flexible Scale-Up Pathways
Startups often begin with milligram to grams scale quantities of material for early studies. Olon USA offers the flexibility to manufacture at these scales and optimize processes for future growth. The site’s infrastructure enables scale-up through 2,000-liter GMP reactors, with the ability to produce clinical and commercial material in batch sizes up to 100 kilograms.
Flexibility extends beyond scale. Some programs require only limited material due to market size. In these cases, Olon USA can deliver commercial supply directly from its kilo lab, which has passed pre-approval inspection, providing a lean and cost-effective pathway.
High-Potency API Expertise
Olon USA’s high-potency API suite provides containment and safety infrastructure for molecules with limited toxicology data. This enables early-stage synthesis and GMP production under strict occupational safety controls. As more data becomes available, processes can be transitioned out of containment if appropriate.
The capability to handle high-potency compounds at early stages reduces risk for startups advancing novel therapeutic candidates.
Process Optimization and Program Rescue
Emerging companies often face challenges when scaling academic or early-stage chemistry into manufacturable processes. Olon USA frequently supports programs that require optimization to eliminate inefficiencies, such as column purifications that greatly reduce batch yield. Process improvements lower cost per batch, increase yield, and provide a more reliable path to scale-up.
The ability to rescue underperforming programs is a key differentiator, protecting both timelines and investment for startup clients. Olon USA is simply has the most experience in the industry at performing development and scale-up work, which increases the odds of success of your program.
Part of Ohio’s Biotech Ecosystem
Olon USA is positioned within Ohio’s Discovery Corridor, surrounded by leading hospitals, universities, and drug development infrastructure. Proximity to toxicology labs, drug product manufacturers, and formulation partners allows startups to leverage a regional ecosystem that accelerates development. This integrated environment reduces logistical complexity and supports rapid advancement.
Cost Efficiency and Risk-Sharing Partnerships
Funding structures for emerging companies are evolving, with capital often released in stages. Olon USA adapts to these realities with flexible project designs and payment terms that align with client funding cycles.
Projects are structured with efficiency in mind. For example, combining toxicology and clinical batches into a single campaign can reduce overall cost while meeting program timeline requirements. This type of problem-solving ensures startups maximize limited resources while advancing toward critical milestones.
Partnering for Long-Term Success
Startups advancing new therapies require both technical expertise and a partner invested in their success. Olon USA provides specialized support for emerging companies, combining the resources of a global CDMO with the focus of a dedicated U.S. development site.
Pharma innovators seeking to advance their molecule efficiently and reliably are encouraged to connect with Olon USA. Reach out today to start a conversation about how Olon USA can support your development and manufacturing needs.