Found 178 results in Expert Content

Summary: A panel of drug developers discuss innovative trial designs, on-demand manufacturing, communicating between clinical partners, prepping a strong regulatory submission and enabling faster decision making in your phase I trial.

Summary: Download this executive summary article to learn about best practices and strategies to mitigate risks and ensure a successful tech transfer from development through to commercial scale spray drying of pharmaceutical products.

Summary: Download this executive summary to learn more about safe and successful HPAPI product development and manufacturing using micronization.

Summary: As drug developers look to address unmet medical needs for orphan diseases, working with experienced partners can help in navigating key challenges such as a limited active pharmaceutical ingredient supply, efficient small-scale manufacturing for small patient populations and distribution logistics

Summary: Decisions made throughout early and mid-stage clinical trials impact late-stage results and sometimes, entire programs and companies. Since some obstacles can prove overwhelming for startups, there is a lot to learn from those who successfully walked the path.

Read this case study to learn about how Catalent deployed its integrated OneXpress® Solution to expedite the transfer of a partner program to one of its late-stage manufacturing sites while optimizing the utilization of a limited supply of API.

Learn how a biopharmaceutical company partnered with Catalent to develop and manufacture a commercially-viable, patient-friendly, stable tablet for a program intended to treat a disease that has unmet medical need.

Summary: Integrated Development Offering to Facilitate Adaptive Trials & Accelerate Phase 1

Summary: During this webinar, biopharma R&D professionals will review strategies for moving successfully and efficiently from preclinical studies to first-in-human trials. They will call upon their own experiences to provide advice that will help others in the industry navigate this crucial transition.

Summary: This webinar will discuss how to classify HPAPIs in early development and share recommendations for safe product handling, from clinical manufacturing to commercialization.