Formulation Development White Papers & Articles

  1. Advancing The Development Of Syringe-Device Combinations 10/22/2026

    Defining the design for syringe-autoinjector pairings early, through shared compatibility testing, can reduce integration risk for high-viscosity biologics intended for self-administration at home.

  2. Nasal Delivery Of Psychedelics: Next Generation Delivery Options 10/22/2026

    Psychedelic development has moved past regulatory hurdles to a question of formulation and delivery. For fast-acting molecules, dosing control and onset speed are pushing developers toward one route.

  3. Early Automation Integration Reshapes How Drugs Move 10/19/2026

    Introducing automation during R&D rather than in Phase 3 changes how processes scale. Unified data and standards-based control logic carry across bench, pilot, and commercial stages with less rework.

  4. Why Controlled Release Is Essential For Patient-centric Drug Development 10/15/2026

    Controlled release design can ease daily dosing burden by moderating swings in drug exposure, though the right approach depends on API properties and what manufacturing can deliver at scale.

  5. Everyday Medicines, Complex Manufacturing: 5 Reasons They Aren't Simple To Make 10/15/2026

    Tablets and liquid medicines look simple to the patient, but their reliability depends on formulation choices made early and on technical expertise that continues well after commercial production begins.

  6. Why Reagent Quality Defines Research Success 10/15/2026

    Water grade, buffer preparation, and packaging each shape whether sensitive assays hold up. Reagent selection hinges on matching purity to application sensitivity, regulatory standards, and tolerance for contamination risk.

  7. Peptide Building Blocks: Navigating Quality, Supply, And Scale 10/14/2026

    Non-canonical amino acids can boost peptide half-life and potency, but create challenges in impurity control, GMP classification, and sourcing. Early supplier choices are critical for commercialization.

  8. Accelerating Complex Generic Drug Development Through Advanced Deformulation 10/13/2026

    With FDA no longer identifying Q1/Q2 differences, applicants bear the diagnostic burden. Reverse engineering now directly affects development speed, cost, and approval.

  9. Why Audit Success No Longer Predicts Clinical-Stage Performance 10/8/2026

    Passing inspections no longer signals that a growth-stage biotech can sustain clinical-stage complexity. The gap between audit readiness and operational readiness opens quietly.

  10. Practical Formulation Strategies For Poorly Soluble APIs 10/2/2026

    Poor aqueous solubility now defines most drug candidates in development, making early screening and solid-state assessment essential to achieving reliable exposure and avoiding costly reformulation downstream.