Case Study
Fast-Track Clinical Transition from Lipid-based Solution to Lipid-based Suspension in Softgels
A clinical-stage biotech focused on neurology faced challenges with a lipophilic, oxidation-sensitive molecule limited by solubility, stability, and scalability.
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Case Study
From IV to Oral: Leveraging Softgel to Extend Vinorelbine’s Lifecycle & Improve Patient Convenience
Vinorelbine, a chemotherapy agent traditionally given by IV infusion, was reformulated into the first approved oral softgel capsule through a collaboration between Pierre Fabre and Catalent.
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Infographic
Spray Drying for Inhaled Drugs: Minimize Risk, Maximize Yield
Summary: Late-stage scaling of spray drying for inhaled formulations can result in avoidable delays, post-approval issues, and cost overruns.
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Webinars
Fast, Flexible, Bioavailable: Lipid-Based Softgels for BCS I–IV
Bringing complex oral drugs to the clinic requires overcoming significant solubility, permeability, and bioavailability challenges.
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Executive Summary
Oral Lipid-Based Formulations: Unlocking Value in Early-Stage Pharmaceutical Development
Summary: Pharmaceutical innovators face growing pressure to overcome solubility, permeability, and bioavailability challenges, especially for complex, poorly soluble molecules.
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Executive Summary
Optimizing Adaptive Trials for Drug Development
Summary: Early clinical trials are becoming more complex as sponsors face rising regulatory requirements and the challenges of developing advanced drug candidates.
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Webinars
Optimizing Micronization and Spray-Drying to Achieve High Yields from Clinical to Commercial
Summary: The pharmaceutical industry faces mounting pressure to deliver consistent, high-quality products whilst managing escalating costs and regulatory demands.
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Executive Summary
Optimizing Product Packaging and Oral Drug Delivery with Stick Packs
Summary: Stick packs are valued for their compact size, ease of use, and portability, offering unique advantages for improving patient adherence and treatment experiences.
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Case Study
Accelerating Phase 1 Trials Overcoming API Constraints and Tight Timelines with On-Demand Manufacturing
Early-phase trials are often delayed by rigid manufacturing models, fixed-dose formats, and limited API availability.
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Case Study
Material-Sparing Formulation Strategies for Enhancing Bioavailability of Challenging Beyond Rule of Five (bRo5) Molecules
Formulating Beyond Rule of Five (bRo5) molecules presents significant bioavailability and development challenges, especially for small or emerging pharma with limited API and constrained budgets.
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