White Papers

  1. Precision In Miniature: Optimizing Multiparticulate Formulations For Pediatric Oncology 9/9/2026

    When an oral liquid formulation of crizotinib failed pediatric trials due to intolerable taste and irritation, a multiparticulate approach offered a technically demanding but viable path forward.

  2. 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.

  3. 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.

  4. The Strategic Value Of In-House Delumping For Homogeneous API Production 9/9/2026

    API batch homogeneity supports efficient manufacturing. Controlled delumping improves powder flow and chargeability while maintaining particle size integrity and reducing GMP-scale risks.

  5. 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.

  6. Enhancing Quality And Environmental Monitoring Efficiency Through Paperless Sampling 9/9/2026

    At roughly 600,000 samples per year, manual EM documentation creates real compliance and operational risk. This whitepaper details how a fully integrated digital sampling system addresses both.

  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. AI Enabled Pharmaceutical Cocrystal Screening 9/3/2026

    Cocrystal candidate screening is resource-intensive and prone to gaps. This paper examines how AI-based modeling, trained on more than 20,000 data points, can sharpen candidate prioritization without sacrificing scientific rigor.