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.
The global pharmaceutical sector is embarking on a transformational journey in which the supply chain will play an increasing strategic role. There will be a need for greater agility and speed to market.
To maintain the proper temperature of vaccines, West Pediatrics relies on Bluetooth low energy (BLE) data loggers for accurate and reliable temperature monitoring.
Europe and the United States are considered the world leaders in the safest pharmaceutical markets for patients. However, the US and Europe are also a lucrative target for drug crime.
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.
This webinar will review how oxygen levels in finished parenteral drug containers can be determined and controlled throughout the product life cycle by using laser-based headspace analysis.