CaseStudies

  1. Producing Quality APIs At Scale 5/7/2026

    Targeted process optimization transformed an early‑phase API with yield and impurity challenges into a scalable, high‑quality manufacturing process ready to support ongoing drug development.

  2. High Drug Tolerance ADA Testing For Long‑Acting mAbs 5/6/2026

    See how advanced ADA assay design overcomes extreme drug interference, enabling reliable immunogenicity assessment for long‑acting, high‑dose monoclonal antibodies in early clinical development.

  3. Enabling Complex Phase IIa Dosing Through Flexible Clinical Packaging Design 5/6/2026

    Discover how flexible, patient‑centric clinical packaging supports complex Phase IIa dosing while protecting timelines, ensuring compliance, and avoiding costly primary packaging changes.

  4. Rapid Selection Of High-Performance CHO Basal And Feed Media 5/5/2026

    A CHO-S bispecific antibody program needed a better basal and feed media combination. Learn how the screening of 180 conditions in 12 weeks identified one that delivered 38% higher titers.

  5. Successful Tech Transfer Meets Commercial Needs 5/5/2026

    An accelerated technology transfer reduced time to PPQ by over 25%, overcoming novel raw materials, unique IP constraints, and late‑stage process optimization to meet urgent commercial demand.

  6. Achieving High Cell Purity With The CTS DynaCellect Magnetic Separation System 4/21/2026

    Learn how closed-system automation, combined with expert technical guidance and protocol optimization, turned a persistent manufacturing bottleneck into a reliable, scalable process.

  7. Overcoming Food Effects, Variability, Solubility For A Non-Opioid Analgesic With Lipid-Based Formulations 3/20/2026

    Develop optimized lipid-based formulations to overcome solubility, stability, and food-effect challenges, enabling high-dose oral delivery and rapid progression to Phase 1 trials.

  8. Overcoming API Constraints And Tight Timelines With On-Demand Manufacturing 3/20/2026

    Use innovative lipid-based formulations and on-demand manufacturing to accelerate Phase 1 trials, enable flexible dose escalation, and maximize limited API for poorly soluble compounds.

  9. Solving Bioavailability Challenges In bRo5 Drugs 3/20/2026

    Leverage mechanistic, material-sparing formulation strategies to enhance bioavailability and accelerate development of challenging bRo5 small molecules, even with limited resources.

  10. Leveraging Softgel To Extend Vinorelbine's Lifecycle, Improve Patient Convenience 3/20/2026

    Develop innovative oral formulations of traditionally intravenous therapies to enhance patient convenience, ensure consistent systemic exposure, and support long-term brand value and market differentiation.