Formulation Development
FORMULATION DEVELOPMENT WHITE PAPERS & ARTICLES
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![cdmo-solid-dose-GettyImages-1432665138]( "How To Achieve Late-Phase Success In Complex OSD Development")
How To Achieve Late-Phase Success In Complex OSD DevelopmentLate-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.
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![GettyImages-1194851415-OSD-oral-solid-tablet-pill-capsule]( "Reducing Uncertainty In Early Oral Drug Development")
Reducing Uncertainty In Early Oral Drug DevelopmentFive 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.
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![GettyImages-2270210340-lipid-nanoparticle-delivery-system]( "Lipid Formulation Development: Why Softgels Are The Technology Of Choice")
Lipid Formulation Development: Why Softgels Are The Technology Of ChoiceLow 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.
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![GettyImages-950086574-oral-solid-OSD-pill-tablet-capsule-development]( "5 Hidden Risks In Early-Phase OSD Formulation Development")
5 Hidden Risks In Early-Phase OSD Formulation DevelopmentEarly formulation decisions in OSD development carry risks that may not surface until later stages, when the cost of course correction is significantly higher.
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![GettyImages-1370967510 hot cold]( "Overview Of Hot Melt Extrusion And Its Pharmaceutical Applications")
Overview Of Hot Melt Extrusion And Its Pharmaceutical ApplicationsMore 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
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![GettyImages-528971880 chromatography]( "Don't Intensify Blindly: Preventing Fouling And Restoring Performance With Targeted Cleaning Of Protein A Resins")
Don't Intensify Blindly: Preventing Fouling And Restoring Performance With Targeted Cleaning Of Protein A ResinsProtein A chromatography intensification can increase productivity, but it may also affect process robustness. Explore key tradeoffs, operational challenges, and practical considerations.
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![GettyImages-899692950-cleanroom-microscopes-scientists-analyze]( "Detect Low-Abundance GLP-1 Impurities With Greater Sensitivity")
Detect Low-Abundance GLP-1 Impurities With Greater SensitivityLow-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.
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![GettyImages-1309780330-HPLC-lab-scientist-chromatography]( "Differentiate Challenging Site-Specific Isomeric Amino Acids")
Differentiate Challenging Site-Specific Isomeric Amino AcidsLearn how high-resolution ion mobility, pre-IMS fragmentation, and product ion analysis can resolve difficult peptide isomers and localize structural differences, supporting confident characterization.
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![Female researcher analyzing scientific samples-GettyImages-2231025177]( "Increase Throughput For Intact Mass Confirmation And Impurity Screening")
Increase Throughput For Intact Mass Confirmation And Impurity ScreeningAccelerate 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.
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![quality control, sterile pharmaceutical manufacturing facility-GettyImages-2277115553]( "Integrated QC As A Development Strategy: Reducing Late-Stage Analytical Risk")
Integrated QC As A Development Strategy: Reducing Late-Stage Analytical RiskLearn 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 PRODUCTS & SERVICES
Gene therapies hold immense potential to provide long-lasting treatments for a wide range of diseases. At Cytiva, we offer GMP-compliant, end-to-end manufacturing solutions designed to support the development and commercialization of advanced medicines across multiple modalities – including AAV, adenovirus (AV), lentivirus (LV), plasmid DNA (pDNA) and exosomes. Our dependable suite of technologies and expertise ensures scalability, quality, and regulatory confidence at every stage of your journey.
Our comprehensive pharmaceutical development service offering includes new drug development, early stage formulation and analytical development for both highly potent and non-potent drug products.
Custom microscopy workstations to meet your advanced imaging needs.
This intuitive and reliable HPLC system supports First Time Quality (FTQ) by reducing the risk of common errors and improving the accuracy of analytical measurements.
Leica DM500 Binocular
Supports a Student Friendly Classroom Environment For Life Science Courses
The Leica DM500 microscope with “plug and play” capability is the ideal tool to make teaching entry-level college and university Life Science courses easy and fun for the instructor and the student.
Student-friendly features such as the pre-focused, pre-centered condenser and the EZTube™ preset diopter, which prevent incorrect adjustments, provide more time for hands-on teaching.
EZStore™ design with integrated handle and cord wrap allows easy carrying, easy lifting and protection against microscope component damage.
The Powder Rheology Accessory expands the DHR’s capabilities to powders, enabling the characterization of behaviors during storage, dispensing, processing, and end-use.
See More with Microflow LC-MS
The M5 MicroLC system is the perfect balance of sensitivity and robustness—more sensitive than traditional analytical flow LC, and more flexible and more robust than nanoflow LC — giving you the potential to optimize your critical workflows, today and into the future.
Measure heat flow, weight loss, dimension change, or mechanical properties as a function of temperature.
FORMULATION DEVELOPMENT SOLUTIONS
- Selected Immunoassays
- Customizable Imaging Workstations
- Unlock Amorphous Solubility Enhancement For Challenging Compounds
- Are You In Control Of Your Protein Galactosylation Profile?
- Disposable Pen For The Self-Injection Of Chronic Disease Medications
- Custom Organ-Chip Models For A Wide Variety Of Applications
- A Quick Guide To Dissolution Testing
- Intelligent, Precise, And Scalable Automation Solution For 3D Biology
- Allegro™ Ready Filter Sets
- Comprehensive Support For Regulated Laboratories With FlexCHOICE Service Coverage
PHARMACEUTICAL AND FORMULATION DEVELOPMENT NEWS
- AST Names Industry Veteran Jon Lenihan As Chief Commercial Officer
- 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