Formulation Development

How To Achieve Late-Phase Success In Complex OSD Development

Late-phase OSD scale-up demands more than technical know-how. This paper examines the frameworks, tools, and partnership models that determine whether promising molecules reach commercial production reliably.

Reducing Uncertainty In Early Oral Drug Development

Five recurring decision points in early oral solid dose development carry outsized downstream consequences. AI/ML-driven predictive modeling is reframing how teams manage those decisions under API and timeline constraints.

Lipid Formulation Development: Why Softgels Are The Technology Of Choice

Low bioavailability affects roughly 80% of APIs, yet many drug developers default to standard OSD forms. This paper examines why softgels deserve earlier consideration in formulation strategy.

5 Hidden Risks In Early-Phase OSD Formulation Development

Early formulation decisions in OSD development carry risks that may not surface until later stages, when the cost of course correction is significantly higher.

Overview Of Hot Melt Extrusion And Its Pharmaceutical Applications

More than 40% of NCEs face aqueous solubility challenges. Here, we examine how hot melt extrusion addresses solubility, modified release, abuse deterrence, and scale-up across pharmaceutical development.

Don't Intensify Blindly: Preventing Fouling And Restoring Performance With Targeted Cleaning Of Protein A Resins

Protein A chromatography intensification can increase productivity, but it may also affect process robustness. Explore key tradeoffs, operational challenges, and practical considerations.

Detect Low-Abundance GLP-1 Impurities With Greater Sensitivity

Low-level impurities can be difficult to resolve using conventional approaches. Discover how a Charged Surface 2.3 µm superficially porous Phenyl-Hexyl column enhances reversed-phase LC-MS analysis.

Differentiate Challenging Site-Specific Isomeric Amino Acids

Learn how high-resolution ion mobility, pre-IMS fragmentation, and product ion analysis can resolve difficult peptide isomers and localize structural differences, supporting confident characterization.

Increase Throughput For Intact Mass Confirmation And Impurity Screening

Accelerate intact mass analysis of GLP-1 analogues with automated purity calculations, sub-ppm mass accuracy, and impurity detection for consistent results in under one minute per sample.

Integrated QC As A Development Strategy: Reducing Late-Stage Analytical Risk

Learn how early QC integration, proactive analytical risk management, and cross-functional collaboration can improve validation readiness, reduce development surprises, strengthen release testing predictability, and help protect critical clinical manufacturing timelines.