Formulation Development White Papers & Articles

1. The People Who Turn An Idea Into A Deliverable Product 9/15/2026

   Drug developers and device engineers share more common ground than their distinct disciplines suggest, facing parallel pressures around design, safety, regulatory approval, and scalable performance.

2. Chromatography Polishing Under Pressure: New Demands 9/11/2026

   Upstream productivity gains and evolving antibody formats are raising the bar for chromatography polishing, making it a more consequential variable in downstream process design.

3. Why CMC Continuity Is The Missing Link Between Development And Manufacturing 9/10/2026

   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.

4. Analytical Method Development For Paediatric Oral Dose Products 9/9/2026

   This article explores the key formulation and analytical challenges that pharmaceutical companies face when creating safe, effective, and age-appropriate treatments for paediatric populations.

5. Solubility And Improved Patient Outcomes 9/9/2026

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

6. Overcoming The Obstacles Of Spray-Dried Dispersion Scale-Up 9/9/2026

   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.

7. An Integrated Analytical Approach To Lipase Risk Management In Biologics Development 9/8/2026

   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.

8. Chemoenzymatic N-glycan Conjugation Of Native mAbs Provides Homogeneous, Efficacious ADCs 9/3/2026

   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.

9. Bringing Novel ADC Formats Into The Clinic: AOC Process Development 9/3/2026

   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.

10. Looking Beyond Solubility And Process Performance 9/2/2026

    Solvent selection for spray-dried dispersions significantly impacts drug performance, scalability, and supply chains. Early, structured solvent choice is vital for successful manufacturing and commercialization.