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The Stability and Formulation stream brings together experts in formulation, analytical sciences, drug delivery, and process science to share knowledge and foster dialogue and collaborations. These two conferences will feature practical insights, case studies, and rapid approaches for predicting protein instabilities and strategies for impurity detection, with a focus on host cell proteins (HCPs). The second part will focus on formulation, analytical, and AI/ML-driven strategies for high-concentration protein formulations, cell and gene therapies, and non-traditional modalities. It also explores drug-device combinations and smart drug-delivery devices.

Conferences Include:

Rapid Methods to Assess Stability and Impurities in Biologics
Formulation and Delivery of High-Concentration Proteins and New Modalities

Keynote Presentations Include:

What We Know and Do Not Know about Analytical Testing for mRNA Characterization
Jianmei D. KochlingJianmei D. Kochling, PhD, Senior Director, Head of Analytical Development and QC, mRNA Center of Excellence, Sanofi


Applying Deep Learning to Predict High-Concentration Antibody Viscosity
Pin-Kuang LaiPin-Kuang Lai, PhD, Assistant Professor, Department of Chemical Engineering and Materials Science, Stevens Institute of Technology



Featured Presentations Include:

Concentrating siRNA by Ultrafiltration for Gene Therapy Applications
Ken K. QianKen K. Qian, PhD, Scientific Director, Eli Lilly & Co.


Efficient HCP Risk Control in Line with Regulatory Perspectives
Erika M. FriedlErika M. Friedl, PhD, Quality Expert, Haematology & Transfusion Medicine, Paul Ehrlich Institute, Germany