Formulation Development

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.

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.

Solubility And Improved Patient Outcomes

Poor solubility poses major development challenges. Innovative formulation technologies and careful excipient selection can improve bioavailability and product performance.

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.

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.

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.