Outsourced Pharma White Papers

  1. Solid State Hydrogen Deuterium Exchange To Study Antibody Drug Conjugate Stability 10/16/2024

    Discover how this solid-state HDX-MS is being used to revolutionize the prediction of stability for IgG-based Antibody Drug Conjugates and enhance ADC development processes.

  2. Mitigating Nitrosamine Risks In Pharmaceuticals 6/25/2024

    Nitrosamines can come from a range of sources, including raw materials, manufacturing processes, and even water sources. Detecting them requires sensitive analytical methods.

  3. Advancing A LNP Formulation To Clinical And Commercial Manufacturing 3/25/2024

    Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.

  4. Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer 3/24/2025

    Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.

  5. Optimizing Poloxamer 188 1/13/2025

    Poloxamer 188 stabilizes proteins in liquid formulations and protects cells from shear stress. Molecular weight and hydrophobicity variations influence its effectiveness in different biopharmaceutical applications.

  6. Super Short Activated CAR-T Process 1/17/2025

    Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.

  7. Navigating The Complexities Of Pre-Filled Syringe Manufacturing 9/4/2025

    Drawing on our extensive expertise in sterile injectables (SI), here, we highlight practical strategies and proven solutions designed to help navigate challenges and support the reliable, scalable production of high-quality PFS therapies for patients worldwide.

  8. Modern Modeling Tools For Small Molecule Solid Dose Manufacturing 3/10/2025

    Data-driven modeling techniques can enhance scale-up processes, streamline production, and help companies navigate the complexities of modern drug development with greater precision and reliability.

  9. Challenges And Solutions In Lyophilization Development For ADCs 12/10/2025

    Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.

  10. Boosting CMC Regulatory Efficiency In Gene Therapy 9/30/2024

    Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.