Outsourced Pharma App Notes & Case Studies

  1. Technology Transfer Considerations 6/13/2024

    Speed and flexibility are crucial in the development of a new drug, from the laboratory to clinical trials and ultimately to the market. Explore considerations for a successful technology transfer.

  2. Overcoming Supply Chain Roadblocks To Ensure Reliable Complex OSD Delivery 2/26/2024

    Ensuring critical oral solid dosage (OSD) therapeutics reach patients successfully relies on the ability of developers and manufacturers to navigate the inherent issues surrounding their increasing complexity.

  3. Residence Time Of Powders In Tablet Compression 7/30/2024

    Knowing how formulation moves through a tablet process is invaluable in optimizing the process for the greatest tablet quality and production.

  4. Meeting Annex 1: A Proactive Approach To Regulatory Compliance 3/4/2025

    It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and value for each customer to comply with the August 2023 revision to the EU GMP Annex 1.

  5. Project Management Considerations For Pharmaceutical Wastewater Systems 6/28/2023

    The wastewater from a pharmaceutical facility was changed to discharge to a city-forced main instead of the existing gravity main. Learn about this wastewater project and CAI's assignment in detail.

  6. Nuances Of Sample Preparation For UHPLC Testing In Early Phase Stability Programs 2/13/2025

    In early-phase drug development, precise sample preparation for UHPLC testing is crucial to ensure accurate and reliable stability data.

  7. Engineering CHO K1 Cells With Three Orthogonal Transposase Systems 2/2/2024

    Transposase-mediated genome engineering enables the robust and stable relocation of discrete DNA segments (transposons) in the genome, providing a valuable tool for stable transgene expression.

  8. Standardizing Cryopreservation For Cell Therapy Supply Chains 6/3/2025

    Explore how a standardized cryopreservation process is transforming leukapheresis handling by reducing risk and improving quality across the cell therapy supply chain.

  9. Using GPS Engineering To Optimize Antibody-Based Drug Development 2/28/2024

    Explore the results collected when a platform designed with ML-guided GPS engineering was applied to develop a lead molecule targeting a mechanism in neuronal disease.

  10. Re-Engineering A Complex Process For FDA Compliance 8/21/2024

    Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.