Article
Concept to Dosing: Challenges in New Orphan Drugs
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
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Webinars
Navigating your Biopharma Drug Candidate Through Early and Mid-Stage Clinical Trials
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.
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Case Study
OneXpress® Solution Case Study – Enabling Successful Scale-Up of a Spray Drying Program
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.
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Case Study
Leveraging Catalent's Integrated Network to Accelerate Spray Drying and Tableting Scale-Up
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.
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Offering Fact Sheet
Xpress Pharmaceutics®
Summary: Integrated Development Offering to Facilitate Adaptive Trials & Accelerate Phase 1
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Webinars
Webinar-Preparing for Phase 1: Strategies for Success in Advancing your Drug to First-in-Human Trials
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.
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Webinars
Highly Potent API Drug Product Development and Manufacturing Using Micronization Technology
Summary: This webinar will discuss how to classify HPAPIs in early development and share recommendations for safe product handling, from clinical manufacturing to commercialization.
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Offering Fact Sheet
Micronization Technology Solutions From Early Phase Development to Commercial Scale Manufacturing
Summary: Catalent is a global leader in pharmaceutical air jet milling micronization with more than 30 years’ experience delivering micronization solutions.
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Webinars
Concept to Dosing-Challenges in New Orphan Drugs
Summary: In this webinar a group of experienced cancer drug developers discusses key strategies in managing an orphan drug program.
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Webinars
A Guide to Drug Development of Challenging Molecules
Summary: This webinar discusses, key considerations of early drug development, molecule developability assessment, drug bioavailability and discussed the relationship between intracellular and transcellular permeability of beyond the Rule of Five drugs.
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