Helen Hou, Ph.D.
Genentech Inc.

Abstract:
Amorphous phase of compounds has been widely used to overcome oral bioavailability
problems related poor solubility and dissolution. Although there are extensive studies that have
investigated the choice of excipients and processes to maintain solid state stability and enhance
biopharmaceutical performance, there are limited studies that assessed the physical-mechanical
properties of ASDs, which are important for downstream development of the final dosage form
of ASDs, especially when high ASD loading in the final drug product is needed to achieve the
target dose without potential pill burden. This presentation will include examples assessing 1)
the effects of ASD manufacturing technology, 2) the impacts of formulation design, such as
drug loading and polymer type on solid-state, particulate, and physical-mechanical properties
of ASDs. This work will provide insights when designing ASD formulations, and guide the
selection of manufacturing technology and the process optimization to deliver ASDs with
desired properties and performance.