Integrated First-in-Human Service Package for Poorly Soluble Small Molecules

Lonza Pharma & Biotech’s SimpliFiH Services takes an integrated approach to addressing bioavailability challenges with drug substance, solid-state characterization, and drug product for first-in-human studies.

According to the company, as drug discovery and development accelerate and solubility and dissolution rate challenges become more complex, new solutions are required to reduce the timeline from initial idea to a first-in-human clinical verification. Lonza’s new service package is suited for companies that have solubility-challenged molecules and require drug substance and drug product services for early-stage development and first-in-human studies. The company states that it has also developed streamlined service agreement templates specific to the SimpliFiH package to reduce time, cost, and complexity for these studies.

The company’s proprietary bioavailability enhancement technology selection methodology serves as the foundation of the services. This methodology consists of databases and models based on more than 25 years’ experience advancing thousands of molecules to Phase I across all key enabling technologies-particle size reduction, solid dispersions, and lipid-based formulations. By using this methodology, a single-enabling approach for early first-in-human studies can be rapidly identified without extensive solubility screening, which reduces early phase clinical timelines and API requirements, according to Lonza.

The services include key drug substance and drug product components required for first-in-human studies for small molecules: drug substance development and supply, solid-state characterization/bioavailability enhancement, and phase-appropriate drug product in powder-in-capsule, powder-in-bottle, liquid-filled hard capsule, or tablet format. Basic analytical services inclusive of stability studies are included in the service package. Regulatory services for supporting, consulting on, or writing investigational new drug and investigational medicinal product dossier applications are available to support first-in-human requirements.

Source: Lonza Pharma & Biotech