The rise of precision medicines, oncology therapies, and targeted treatments has significantly increased the development of highly potent active pharmaceutical ingredients (HPAPIs). These compounds are designed to deliver therapeutic effects at very low doses, often improving patient outcomes while minimizing adverse effects. As a result, HPAPIs represent one of the fastest-growing and most tightly regulated segments of global pharmaceutical development.
Due to their high biological activity, HPAPIs demand specialized knowledge, strict containment strategies, and purpose-built infrastructure to safely progress from formulation through clinical manufacturing and commercial production. Successful handling depends on combining scientific expertise with advanced engineering controls to protect personnel, facilities, and product integrity.
With decades of experience supporting high-potency programs, our teams specialize in the formulation, development, and manufacture of drug products containing HPAPIs within dedicated high-containment Grade C and D environments. Our scientists and engineers support the full development lifecycle, including analytical method development, qualification, validation, and scale-up activities.
We deliver efficient and cost-conscious manufacturing solutions, advancing projects from early prototypes to commercial-scale batches. Our formulation capabilities span multiple dosage forms and technologies, including micronized and nanoparticle-based systems enabled through advanced size-reduction and dispersion techniques.
Each new API undergoes a comprehensive risk assessment to establish appropriate handling requirements and exposure limits. Using performance-based exposure control limits (PB-ECLs), compounds are classified into potency categories ranging from Class 1 to Class 4. This classification determines the containment strategy, facility controls, and procedural safeguards required for safe development and manufacturing.
Our 64,000-square-foot cGMP-compliant facility is engineered specifically to address the challenges associated with HPAPIs and other highly toxic or controlled substances. Key features include:
To minimize occupational exposure and ensure uncompromising safety, we implement multilayered containment and monitoring strategies across all HPAPI operations: