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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An Integrated Analytical Approach To Lipase Risk Management In Biologics Development
Conventional HCP testing cannot confirm whether residual lipases remain enzymatically active. Here, the authors examine why functional activity data are essential for managing polysorbate-related stability risk in biologics development.
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
- Single-Use Chromatography System For Advanced Downstream Bioprocessing
- Be Unstoppable With Comprehensive Charge Variant Analysis
- Trilysine Acetate: Enabling Advanced Surgical, Drug Delivery Tech
- Biocatalysis For Cost-Efficient, Environmentally Friendly Manufacturing
- Small Molecule Discovery Network And Capabilities
- Single-Use Automated Virus Filtration System
- Custom Organ-Chip Models For A Wide Variety Of Applications
- Increased Productivity Powered By An Automation Workstation
- Predict And Assign Fragment Ions
- Solutions For Aggregate And Fragment Analyses
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
- AES Cleanroom Technology Panels Earn FM 4882 Approval, Addressing The Cleanroom Risk That Fire Ratings Miss
- 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