Formulation Development
FORMULATION DEVELOPMENT WHITE PAPERS & ARTICLES
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Why CMC Continuity Is The Missing Link Between Development And Manufacturing
Discover why CMC continuity is the missing link between development and manufacturing, and how preserving connected product and process knowledge helps reduce handoff risk, accelerate tech transfer, and strengthen manufacturing readiness.
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Analytical Method Development For Paediatric Oral Dose Products
This article explores the key formulation and analytical challenges that pharmaceutical companies face when creating safe, effective, and age-appropriate treatments for paediatric populations.
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Solubility And Improved Patient Outcomes
Poor solubility poses major development challenges. Innovative formulation technologies and careful excipient selection can improve bioavailability and product performance.
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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.
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
- Get Drug Formulation Right From The Start
- Drug-Drug Interaction (DDI) Studies
- The In Vitro Model Redefining Drug Discovery And Development
- Process Liquid Preparation Services
- CHO Residual DNA Quantitation
- Molecule To Cure. Fast.
- Eliminate Doubt With Chemistry Technical Services
- MaxPeak Premier For Glycan Analysis
- MaxPeak Premier Columns For Intact And Subunit Protein Analysis
- The Power Of One: mRNA Services
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