BRATISLAVA, Slovakia, June 5, 2026 – Biologics do not always give clean answers.
A formulation change, a delayed shipment or a thin stability protocol can quickly become more than a technical issue. It can shape how a product is understood in the CMC dossier, especially when shelf-life claims depend on limited real-time data or accelerated stability studies that need careful interpretation.
Fleming has announced Stability & Shelf Life of Biologics, taking place 27 & 28 October 2026 in Rome, Italy & Online Live Stream, from 9:00–17:30 CEST.
The two-day agenda follows the problems developers regularly face with biologics stability. Protein instability, excipient choice and analytical methods are treated as connected decisions rather than separate workstreams. Degradation pathways such as oxidation, deamidation and aggregation affect what teams measure, how they measure it and how results are explained to regulators.
It also places emphasis on stability protocols, accelerated and stress stability assessment, packaging and transport risks, and regulatory expectations for biologics. That focus reflects a practical concern for development teams: stability data must explain not only whether a product remains within specification, but why the shelf-life position is scientifically defensible when formulation, transport or manufacturing conditions change.
Packaging and transport also sit close to the science. Temperature excursions, container-closure risks and shipping qualification can influence cold chain stability well before a product reaches clinical or commercial use.
Dr. Jörg Engelbergs and Dr. Robert E. Zoubek will lead the full two-day agenda, including case-based work on stress testing biologics, in-use stability, bracketing, EU stability protocols, ICH Q5C, ICH Q1A-F and ICH Q5E comparability after process changes.
Media and registration inquiries:
Karthik Naik | E: [email protected] | T: +421 257 272 100 | W: fleming.events