The Driving Force for Integration of Discovery, Formulation, and Process Design to Produce Biopharmaceuticals

ABSTRACT

Biopharmaceutical development requires close integration of discovery, formulation, process design, and manufacturing to deliver safe, effective, and competitive medicines. This presentation examines how protein instability, particularly aggregation and particle formation, can compromise product quality, increase manufacturing losses, and contribute to immunogenicity risk. Examples illustrate how formulation choices, processing equipment, and product contact materials influence protein stability, and why routine compendial testing may require complementary, more sensitive analytical methods. An integrated, Quality by Design approach is proposed, emphasizing early developability assessment, mechanistic understanding of degradation, and coordinated selection of formulations and manufacturing processes. By incorporating particle detection and control throughout development, manufacturing, and clinical administration, cross-functional teams can reduce development risk, improve manufacturing efficiency, and create differentiated products that better meet patient needs.

BIOGRAPHY

Dr. Danny Chou is a biopharmaceutical industry veteran with expertise in biopharmaceutical characterization, formulation development, and drug product manufacturing. Currently, Dr. Chou is the Founder and President of Compassion BioSolution, a biopharmaceutical consultancy and Contract Development Service provider that serves clients throughout the world. Over the past 20 years Dr. Chou has led the development of formulations for numerous therapeutic modalities ranging from peptides, growth factors, mAbs, ADCs, and bispecific antibodies. Prior to starting Compassion BioSolution in 2015, Dr. Chou was a Senior Scientist and Group Leader at Gilead Sciences, where he successfully built up state-of-the-art analytical capabilities for the company and converted IV formulations of monoclonal antibodies to high concentration formulations that are more stable and can be easily administered by subcutaneous injection. Prior to this, Danny was employed by Genzyme and Amgen, where he played critical roles in drug product process development, manufacturing technical support, and pharmaceutical development. Since founding Compassion BioSolution, Danny has developed stable pharmaceutical dosage form for clients ranging from small start-up biopharmaceutical companies to Fortune 500 pharmaceutical companies. Danny received his PhD from the University of Colorado Center for Pharmaceutical Biotechnology under a NIH Fellowship and his PharmD from the University of Florida

ATTENDANCE

This event is open to all SES faculty, staff, students, alumni, and invited guests.