Outsourced Pharma App Notes & Case Studies

  1. Predicting Softgel Stability And Shelf Life Using Accelerated Modeling 7/15/2026

    Predict ibuprofen softgel shelf life in 21 days instead of years. ASAPprime modeling identified PEG-ester degradants as the limiting factor, estimating 5.5-year and 3.8-year shelf lives before long-term studies concluded.

  2. Site Transfer Of Tablet Production From Ex-U.S. To Georgia Site 6/11/2025

    Explore how strategic U.S.-based manufacturing and supply chain diversification can reduce risk, lower costs, and enhance supply reliability for pharmaceutical products.

  3. Production Of A Highly Concentrated Monoclonal Antibody 10/4/2024

    The production of a highly concentrated monoclonal antibody requires many process steps. Discover how to achieve a final mAb concentration above 200 g/L while maintaining critical quality attributes.

  4. Adapt Or Fail: The Urgency Of Pandemic Preparedness For Sterile Injectable Manufacturing 5/12/2025

    A successful large-scale public health emergency response requires adaptable manufacturing capabilities, an experienced workforce, and effective private-public partnerships.

  5. Cell Culture Media Filtration: Evaluating Cell Culture Performance 10/23/2025

    Cell culture performance remained consistent across PES and PVDF filters, even under worst-case filtration conditions. Discover a practical framework for evaluating membrane impact on CHO cell growth.

  6. Boosting Quality And Reducing Complexity With A Single-Provider PV Solution 4/17/2026

    Discover how a German biopharmaceutical company successfully managed growing global pharmacovigilance complexity across more than 2,300 marketing authorizations and a broad partner network.

  7. Seamless Process Transfer Using An In Silico Bioreactor Scaling Tool 3/24/2025

    Transferring cell cultures between scales is challenging and error-prone. Discover a bioreactor scaling software that predicts optimal settings to enable efficient scale-up and progression to clinical studies.

  8. Scalable rAAV9 Production Using Advanced Cell Lines And Bioreactors 6/15/2026

    Progress in gene therapy manufacturing is being driven by improved cell line performance and scalable bioprocessing. See how high-density growth helps streamline development to larger-scale production.

  9. Accelerating A Complex Molecule From CLD To cGMP In 12 Months 11/19/2025

    Learn how to mitigate technical risk, implement parallel process development, and design custom purification strategies for highly sensitive novel modalities to accelerate to cGMP material.

  10. Fast-Tracking NDA Approval For A Novel Compound To Treat Infections 6/2/2026

    Strategic tech transfer and scalable manufacturing enabled rapid NDA approval, delivering registration batches and accelerating commercialization of a novel therapy for drug-resistant infections.