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.
A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.
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.
This webinar presents how to design and conduct studies to assess the total oxygen permeation rate of your pre-filled syringes, and how to determine if the permeation is primarily through the plunger or through the tip. Protecting oxygen-sensitive formulations during filling will also be discussed.
This webinar describes how non-destructive headspace moisture analysis can be used for characterizing batch moisture distributions, for lyo cycle development and optimization, and for freeze dryer moisture mapping and validation.