In this project, Thermo Fisher Scientific worked with a multinational biopharmaceutical company to investigate trace element variability in its custom cell culture media. Within a year, using a risk-based, collaborative approach, both teams were able to thoroughly characterize incoming specific raw materials and implement proactive measures for reducing the risk of impurities, ultimately providing the company with a long-term risk mitigation strategy.
ADVANCEMENTS IN GLP-1 ANALOG FORMULATION DEVELOPMENT: OVERCOMING CHALLENGES IN ORAL DELIVERY
February 14th 2025Obesity is a significant global health challenge that requires lifestyle changes and effective pharmacological treatments to overcome. Human glucagon-like peptide 1 (GLP-1) analogs, also called incretin mimetics, have emerged as a promising obesity treatment option. Additionally, oral GLP-1 formulations represent a groundbreaking advance in obesity treatment, offering greater patient comfort and adherence to expand the therapeutic market.
Flexible-Dose Development Strategies for Today's Clinical Landscape - Executive Summary
January 8th 2025This executive summary focuses on dose-flexible manufacturing strategies and their role in drug development. Dose flexibility is increasingly important for early clinical studies, particularly in areas such as pediatric medicines and oncology. However, flexible dosing strategies are often neglected or not prioritized early in development. This presentation will focus on technical strategies that can help anticipate appropriate timing for implementation and how to do so cost effectively while adhering to required timelines.