Formulation Development White Papers & Articles

  1. 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.

  2. 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.

  3. 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.

  4. Excipients For Respiratory Delivery Of Biologics 9/9/2026

    With only 105 FDA-approved excipients for nasal and inhalation routes, formulating biologics for respiratory delivery demands precise excipient selection across both liquid and solid dosage forms.

  5. Rational Design And Material-sparing Strategies For Enabled Intermediates And Drug Products 9/9/2026

    A material-sparing strategy integrating formulation mapping, lab-scale spray drying, and compact screening can accelerate risk identification and inform first-round tablet formulation decisions for poorly soluble APIs.

  6. Navigating The Development Of Dry Powder For Inhalation 9/9/2026

    A CDMO-authored framework for navigating dry powder inhaler development, covering target product profile definition, API characterization, particle engineering technology selection, and encapsulation considerations.

  7. 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.

  8. 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.

  9. 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.

  10. 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.