Outsourced Pharma App Notes & Case Studies

  1. Expanding The OSD Toolbox: An Industry Approach To Adsorb Lipids Onto Powder Substrates 12/11/2024

    Explore innovative solutions for improving the solubility and bioavailability of poorly soluble compounds in solid oral dosage forms to enhance drug delivery and therapeutic effectiveness.

  2. Improve Speed To Market By Mitigating Vial And Stopper Incompatibility 10/1/2024

    These studies indicate that with a properly assembled vial containment system, good CCI performance can be achieved with stoppers of a given elastomer, independent of configuration/size, or vial style.

  3. Engineering The Future Of Lipsomal Drug Delivery 5/14/2025

    Explore our full collection of case studies to discover how liposome technology is transforming drug delivery across a wide range of therapies.

  4. Confirming Structural Consistency With HDX-MS 8/14/2026

    To support regulatory confidence, a biopharma company evaluated whether manufacturing changes affected its monoclonal antibody's higher-order structure.

  5. Enhancing Drug Performance Through Lipid-Based Formulations For CNS Indication 3/11/2026

    Advance CNS-penetrant therapies by optimizing oral formulations to improve bioavailability, stabilize the API, and deliver more consistent and reliable drug exposure.

  6. Sterilizing Filtration During Small Molecule Drug Formulation And Filling 6/22/2026

    Sterile drug production relies on both prevention and remediation of contamination. A multi-stage filtration strategy reduces microbial load, protects critical filters from fouling, and ensures consistent product quality, process efficiency, and patient safety.

  7. Replicate Bioscience And Cytiva Collaborate To Deliver srRNA-LNP Vaccines 3/24/2025

    Discover how self-replicating RNA (srRNA) can revolutionize vaccine development with sustained protein expression, lower doses, and fewer side effects to advance next-gen RNA therapeutics.

  8. Extractables In Single-Use Systems Used In ADC Manufacturing 9/23/2024

    To address concerns about using organic solvents in the ADC process, extractables studies were conducted on a disposable chromatography column housing and two different disposable flow paths.

  9. AOC GMP Manufacture For A FIH Study 12/5/2025

    Successful development of AOCs for FIH studies requires robust GMP processes and efficient scale-up. A key step is careful management of a multi-day conjugation process with vital in-process checks.

  10. AOC Conjugation – mAb With SiRNA 12/5/2025

    See how to overcome risks in mAb-SiRNA conjugation, including disulfide scrambling and SiRNA deconjugation, by using advanced chemical and operational solutions to improve material yield and stability.