Advancing Formulation Strategies for Complex Drug Products | DDF Summit Berlin

As drug products become more complex, formulation development is increasingly central to stability, performance, and long‑term manufacturability. The DDF Summit Berlin brings together formulation and drug delivery experts to explore how scientific, data‑driven strategies can mitigate risk across development stages.

Key themes include aligning formulation design with stability understanding early in development, ensuring approaches remain viable as programs progress, and regulatory expectations evolve. Discussions span liquid and lyophilized dosage forms, identification of physical and chemical instability mechanisms, and the role of stress and stability studies in guiding formulation optimization and CMC decision‑making.

Emphasis is placed on molecule‑specific approaches supported by analytical insight, rather than applying standardized solutions. By connecting formulation design, stability behavior, and analytical characterization, these conversations highlight how early, informed decisions can improve robustness, support scale‑up, and enable reliable drug product development from early feasibility through later stages.