Manufacturing & Analytical Characterization

Sustainable Innovation for Manufacturing Amorphous Solid Dispersions

Partner Presentation Speaker(s)

• 

  Adi Kaushal, PhD (he/him/his)

  Technology Head, Bioavailability Enhancement
  Lonza
• 

  Craig Sather

  Principal Investigator, Associate Director CMC
  Lonza

A significant majority of new chemical entities (NCEs) in pharmaceutical pipelines have poor aqueous solubility, thereby limiting oral bioavailability and hindering their progression as therapies for patients. Amorphous solid dispersions (ASDs) are the proven technique to enhance bioavailability for challenging NCEs.

We will describe our approach to defining the appropriate bioavailability enhancement solution while considering sustainability and commercial viability. Our material sparing innovations in hot melt extrusion (HME) screening allow us to evaluate the feasibility of HME in parallel with spray drying to select the most appropriate pathway to progress an ASD. In instances where spray drying is the selected technology, we describe innovative approaches to reducing solvent consumption thereby improving sustainability. Our early phase clinical manufacturing enables fast-to-clinic supplies through a combination of ASD expertise, equipment parity with development, and early-phase appropriate GMP procedures. As programs advance, we use seamless scale-up strategies to enable late-stage and commercial products based on ASDs.