Technology selection for bioavailability enhancement
At Lonza, we appreciate that choosing the best enabling technology (or technologies) for achieving adequate bioavailability (BA) can be complex. Candidate molecules and target product profiles are increasingly challenging. Problem statements may need to be redefined. The need for accelerated timelines is commonplace. Trial and error approaches are inefficient, costly and waste precious new chemical entity.
That’s why we have developed a fundamental, model-based approach to technology selection. Predictive modeling, reference maps across key compound parameters and technology selection methodologies are in place which facilitate rapid selection of enabling technology for addressing BA challenges. Our proprietary approach has been developed through the investigation and advancement of over 4000 molecules, and is based on a set of overriding principles:
- A full understanding of the BA-limiting factors is crucial and includes both physicochemical and biological factors
- The diverse needs of drug compounds cannot be addressed by any single technology
- Development success, and rapid advancement of a compound, is more probable with matching the compound properties and drug product needs early in the development process
- In many cases, more than one technology can be utilized successfully and commercial considerations such as desired dosing format can play a decisive role
- Speed to clinic and market is best ensured by a focus on manufacturability during product design, thereby reducing the need for reformulation and facilitating rapid scale-up
These established technology selection methodologies are integral to our SimpliFiH® Solutions first-in-human service offering for the rapid advancement of BA-challenged molecules. Additionally, phase-appropriate and specialized processing equipment ensure rapid scale-up from concept to clinic and commercialization.