Insights On Drug Development

  1. 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.

  2. 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.

  3. Continuous Lyophilization: Accelerating Freeze-Drying Development 9/9/2026

    Continuous lyophilization is compressing freeze-drying cycle times from days to hours. This webinar examines how the approach is being implemented in development labs with a path to GMP manufacturing.

  4. 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.

  5. Controlling Complexity In ADC Formulation Development 9/9/2026

    ADC formulation development requires a molecule-specific approach that accounts for the interplay between antibody, linker, and payload, and the stability trade-offs that mAb development experience cannot fully anticipate.

  6. 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.

  7. How To Overcome Early Development Challenges Before They Impact Your Program 9/3/2026

    Poor manufacturability and immunogenicity can delay development. Learn how early developability assessments support IND readiness.

  8. 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.

  9. Commercial Packaging: Understanding Challenges And Avoiding Common Mistakes 9/3/2026

    Global product launches bring packaging challenges. Discover ways to balance compliance, sustainability, patient needs, and cost while reducing risk.

  10. Analytical Blind Spots That Derail Microbial Programs Before The Clinic 9/1/2026

    High refolding yields aren’t enough. Learn how analytical characterization, structural equivalence testing, and optimized fermentation reduce scale-up risk and improve quality.