Lonza Pharma & Biotech has launched SimpliFiH Services, integrating its expertise in addressing bioavailability challenges with drug substance, solid-state characterisation and drug product for first-in-human studies.
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 has been specifically designed for innovator companies that have solubility-challenged molecules and require drug substance and drug product services for early-stage development and first-in-human studies.
Streamlined service agreement templates specific to the SimpliFiH package have also been developed to further reduce time, cost and complexity for these studies.
Dr Christian Dowdeswell, VP and Head of Dosage Forms & Delivery Systems at Lonza Pharma & Biotech, said: “The majority of preclinical candidate molecules require bioavailability enhancement, many even for early phase studies.”
Solubility solutions
The foundation of SimpliFiH Services is the company’s proprietary bioavailability enhancement technology selection methodology. This methodology encompasses 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 thereby reduces early phase clinical timelines and API requirements.
SimpliFiH Services encompasses the key drug substance and drug product components required for first-in-human studies for small molecules: drug substance development and supply, solid-state characterisation/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 SimpliFiH Services. Regulatory services for supporting, consulting on or writing IND and IMPD are available to support first-in-human requirements
