The advantages of biologics over their small molecule predecessors are not without their costs. This e-book addresses the challenges in managing the biologic supply chain.
Emerging biopharmaceutical company teams up with clinical services company to stay on track with timelines and ensure funding milestones were met when faced with unexpected lack of bandwidth and limited global organizational experience.
World-class logistics facilities with state-of-the-art IT infrastructure implement new monitoring system allowing real-time monitoring and data recording, and meeting the requirements of FDA 21 CFR Part 11.
Introduced to the pharmaceutical industry decades ago, lipid-based drug delivery systems are the most well-studied and widely utilized technology among all available bioavailability enhancement technologies. Lipid-based drug delivery systems have delivered more than 60 unique drug molecules to market – and counting. Watch this webinar to learn more about the importance of and recent developments in lipid-based drug delivery systems, novel lipid excipients, models, and screening tools for early phase development of lipid-based drug delivery systems, and using mechanistic studies and modeling to predict the impact of lipids on oral absorption.
Many biopharmaceutical drug formulations have some degree of oxygen sensitivity. Topics for this webinar include how oxygen levels in finished parenteral drug containers can be determined for oxygen scavenger & stability studies, for determining inherent primary packaging integrity, and for optimizing & qualifying inert gas purging system during filling.
When CDMOs understand what motivates drug innovators to outsource, who is involved in the service provider selection decision, and which CDMO attributes have the greatest influence on CDMO selection they are able to communicate what is unique about their offering to the right audience at the right time.
This webinar describes the use of positive controls as an important element of CCI studies designed to validate packaging components for CCI or to qualify processes for producing good CCI.