Developing & Manufacturing Drugs with HPAPIs
Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. The level of containment necessary for a potent drug product is not just limited to potent or non-potent classification. The degree of potency and specific risks will determine the level of containment needed to ensure operator safety and prevent cross contamination at the development and manufacturing facility. This article discusses how to effectively classify highly potent APIs (HPAPIs), and to help develop containment protocols and manufacturing processes that are both safe and efficient.
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.
