Formulation Development White Papers & Articles

  1. Right From The Start: Smarter Developability For Stronger Formulations 2/4/2026

    Early developability assessment integrates manufacturability, QbD, flexible formulations, and CDMO support to cut risk, speed development, and enable scalable, robust drugs.

  2. NGS In GMP Manufacturing: Reducing Risk, Increasing Return 1/29/2026

    Global regulators now recognize NGS as a rigorous, GMP‑ready tool for viral safety, driving a shift toward scalable quality strategies. Learn why NGS is becoming central to modern manufacturing.

  3. A Word With Susan Li, Peptide Chief Scientist, Asymchem 1/29/2026

    An overview of emerging TIDES innovations, from greener synthesis to digital tools that boost control, efficiency, scalability, and reliability across complex development workflows.

  4. Selecting A CDMO For Custom Activated PEGs 1/27/2026

    Custom-activated PEGs require thoughtful planning and precise analytical control. Discover key considerations for selecting a partner capable of supporting scalable, compliant PEGylation.

  5. Assessing Developability And Designing Advanceable Formulations From The Start 1/15/2026

    Discover how early developability assessments and a quality-by-design approach can streamline formulation, reduce risk, and accelerate your path to successful, cost-effective drug development.

  6. Navigating Emerging Therapeutics: Cannabinoid And Psilocybin Drug Development 1/15/2026

    Cannabinoid and psilocybin therapies are advancing rapidly, and Mikart supports innovators with DEA-licensed facilities, formulation expertise, regulatory guidance, and manufacturing capabilities from clinical development to commercialization.

  7. Improving Swallowing And Palatability With Patient‑Friendly Forms 1/15/2026

    Improve medication adherence and health outcomes by developing patient-friendly dosage forms that enhance swallowability and palatability for pediatric, geriatric, and dysphagic populations.

  8. Fast-Tracking FIH To PoC: Strategies For Accelerated Drug Development 1/12/2026

    Three factors often decide success or failure in FIH studies: integrating biomarkers and pharmacodynamic endpoints, including patients in the trials, and leveraging purpose-built manufacturing infrastructure.

  9. Matrix Approach Enhances Potency Assay Development For ATMPs 12/22/2025

    Potency assays for ATMPs demand precision. Learn how a matrix approach, regulatory alignment, and advanced technologies can overcome variability and ensure safety throughout the product lifecycle.

  10. Doubling Up For Speed In Biomanufacturing 12/12/2025

    Accelerate drug development and reduce risk with parallel operations. Learn how leveraging CDMO partnerships while building internal capabilities can cut costs and speed your path to market.