Stability & Shelf Life of Biologics (Advanced Bio Stability)
Rome, Italy, October 27, 2026
TL;DR
Led by internationally recognized experts Dr. Jörg Engelbergs and Dr. Robert E. Zoubek, the program focuses on biologics stability testing, shelf-life assessment, ICH Q5C compliance, accelerated stability studies, stress testing, analytical methodologies, formulation development, excipient selection, packaging validation, transport qualification, and cold chain management. Participants will benefit from expert-led presentations, practical case studies, interactive workshops, live Q&A sessions.
About the Event
The training course covers the latest developments in biologics stability testing and shelf-life assessment, with a strong focus on regulatory compliance and product quality. Key topics include ICH Q5C guidelines, accelerated and stress stability studies, biologics degradation mechanisms, protein stability, monoclonal antibodies, biosimilars, analytical methodologies, formulation development, and excipient selection. Participants will also explore packaging validation, transport and shipping impacts, cold chain management, stability protocol design, shelf-life justification, comparability studies, and European regulatory requirements. Through expert-led presentations, practical case studies, workshops, and interactive discussions, attendees will gain actionable knowledge to improve stability programs, support regulatory submissions, and enhance the quality and lifecycle management of biologic products.
Organization
Stability & Shelf Life of Biologics is organized by Fleming
Date and Location
The lecture will take place in Rome, Italy on October 27, 2026.
Attendance to the this lecture is Mixed.
For more information, you can click here to access to the event website.