It is common to have a limited amount of API in the early phase of drug development, which often impedes the rapid progression of drug development. This article describes a new approach that enables the use of industrial scale machines from the very beginning and has resulted in high quality output for cGMP processes, and optimized the yield of small batch size production.
This case study describes the unique challenges one biopharmaceutical company known for the development of novel therapeutics faced when needing a custom packaging and distribution solution for a biohazardous frozen drug product. In the end the product was successfully packaged in sufficient quantity and on time for the Phase I trial, learn how.
Accurate and timely delivery of clinical trial supplies helps to ensure that a study’s timeline stays on track. Sponsors often focus on upfront planning to ensure sites are prepared to reach clinical milestones but ignore the logistical challenges of reconciling and destroying clinical returns. This article breaks down how to effectively manage the clinical supply returns process and how to design a more holistic strategy.
Whether you have a large, complex global study or need a small, regional solution, we can reliably supply your clinical trial anywhere in the world. From Phase I to Phase III and beyond, we are the catalyst for your success.