Jun 21, 2023 · The AKM methodology was evaluated through a cross-company perspective on stability modeling for key stability indicating attributes of different types of biotherapeutics, vaccines and …

Aug 1, 2025 · Predictive Stability: A combination of computational modeling and scientific risk-based approaches that describes or forecasts changes in biopharmaceutical attributes over days, months, …

Future data remains within worst case prediction intervals, suggesting prediction estimates from early non-GMP probe stability batch can predict future batch success, i.e. overall product success …

1 day ago · Comprehensive Stability Assessment of Biotechnological Products: Degradation Mechanisms, Statistical Tools, and Regulatory Compliance, Part 2 Statistical methods provide critical …

May 16, 2025 · The integration of AI and ML into biopharmaceutical formulation design has revolutionized the prediction and optimization of antibody stability and viscosity. By analyzing …

We also examine risk assessment and mitigation strategies that increase the likelihood of success for moving the right candidate into the clinic. KEYWORDS: Antibody, biologics, colloidal, conformational, …

Component of a comprehensive stability program What are the challenges to predict the stability behavior and set the shelf-life using stability modeling for biologics? Which biologics are well suited …

Jun 20, 2023 · It is demonstrated that stability predictions up to 3 years for products maintained under recommended storage conditions (2-8 °C) or for products that have experienced temperature …

Rapid Methods to Assess Quality & Stability of Biologics conference will bring together experts in analytical and formulation development to discuss rapid and practical ways to accelerate prediction …

Aug 19, 2024 · Over recent years, confidence has been gained that predictive stability modeling approaches using statistical tools, prior knowledge and industry experience enable, in many …