Formulation Development
FORMULATION DEVELOPMENT WHITE PAPERS & ARTICLES
-
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.
FORMULATION DEVELOPMENT APPLICATIONS & STUDIES
-
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.
FORMULATION DEVELOPMENT SOLUTIONS
- Gibco Efficient-Pro Medium And Feeds Evaluation Guide
- Evolve The Future Of Cell Therapy Manufacturing
- A Technology-Driven CDMO Delivering Integrated End-To-End Services
- Rapid Sterility Testing: Actionable Results In Less Than 5 Hours
- RNA 9000 Purity & Integrity Kit
- Speed, Scale, And Supply With Innovative Cell Culture Solutions
- Empowering Biologics Development With HRMS Services
- Customizable Imaging Workstations
- MaxPeak Premier Columns For Protein SEC Analysis
- High Potency API Development And Manufacturing
PHARMACEUTICAL AND FORMULATION DEVELOPMENT NEWS
- JHS And Altoura Selected For BioTools Innovator VANGUARD Level Up-XR Program
- Syntegon Launches New Pilot Scale Tablet Coater For Small Batches
- Cambrex High Point Completes FDA, PMDA And TGA PreApproval Inspections, Advancing Commercial Manufacturing Capabilities
- CleanSpace Names Pharma Industry Veteran Will Knapp Midwest Sales Director
- METTLER TOLEDO Introduces LightningBuild Program For Four-Week Delivery
- Eurofins CDMO Alphora Expands Kilolab And High Potency Development And Manufacturing Capabilities
- Ypsomed Opens Production Site In China
- Ypsomed Launches YpsoLoop As The First Autoinjector Platform Designed For Circularity
- Ypsomed Expands Offering For Clinical Studies
- Ypsomed Receives The Red Dot Design Award 2026 For YpsoLoop