Progress in formulation development continues to generate value within the biopharmaceutical industry by addressing critical drug delivery performance needs, enabling patient centricity demands and creating flexible manufacturing approaches for efficient scaling. While some challenges have been met there remain many which still require continued investment in new materials, their applications and processing to stabilize and deliver small molecules, peptides, oligonucleotides/RNA, and biologics. Further, to understand the mechanisms by which these formulation/material approaches act increased use of molecular level analytical and in-vitro techniques is required. Increasingly data capture (cloud), statistical methods (machine learning) and modeling will also continue to become critical tools to drive desired empirical and mechanistic insight and outcomes. This lecture will review current examples of where formulation development has brought forward value, the tools used to understand these formulations and finally, examples of unmet challenges for today’s increasingly complex molecules. Forward looking manufacturing concepts will be briefly covered. The talk will benefit those who seek to learn more broadly about trends in industrial formulation development.

Opportunities to utilize existing and new materials, processing and analytical measurements for formulation development: An industrial perspective

ACS Spring Meeting 2021

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.