Formulation Development
FORMULATION DEVELOPMENT WHITE PAPERS & ARTICLES
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Overcoming The Obstacles Of Spray-Dried Dispersion Scale-Up
SDD scale-up introduces scale-dependent risks that threaten bioavailability, stability, and manufacturability. This white paper details a model-based framework for managing those risks from early feasibility through commercial production.
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Chemoenzymatic N-glycan Conjugation Of Native mAbs Provides Homogeneous, Efficacious ADCs
A chemoenzymatic two-stage protocol enables DAR2 ADCs from native, non-engineered mAbs via glycan remodeling at Asn-297 and copper-free click chemistry, with in vivo efficacy outperforming a comparable marketed ADC.
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Bringing Novel ADC Formats Into The Clinic: AOC Process Development
Antibody-oligonucleotide conjugates introduce conjugation and purification challenges that standard ADC process development wasn't designed to solve. This white paper details practical approaches for each.
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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.
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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.
FORMULATION DEVELOPMENT APPLICATIONS & STUDIES
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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.
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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.
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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.
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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.
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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
- A Rapid Workflow For High‑Resolution Protein Analysis
- Peptide Development Strategies
- High-Content Screening System
- Simplify Your Linker-Payload Synthesis
- Early Development: Accelerating Molecules Through To Proof-Of-Concept
- Gain Human-Relevant Insights With Patient-Derived Assay-Ready Organoids
- OSD Capabilities Overview
- Control Your Bioprocess Development: Faster Decisions With Quality Data
- MaxPeak Premier Columns For Intact And Subunit Protein Analysis
- Global Experts In Nanotechnology And Drug Particle Engineering
PHARMACEUTICAL AND FORMULATION DEVELOPMENT NEWS
- Jubilant HollisterStier Announces First FDA Commercial Product Approval For Sterile Fill-Finish Line 3
- Ardena To Attend CPHI Worldwide Milan 2026, Launching Charity Step Challenge "From Molecules To Miles"
- 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