Outsourced Pharma App Notes & Case Studies

  1. Integrated Strategies for Achieving Regulatory Milestones Faster 10/12/2023

    Learn how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.

  2. From Design To Operation: Supporting GMP Facility Readiness 8/20/2025

    Explore GMP facility readiness from design through operation, offering validation, quality systems, training, and ongoing compliance to ensure efficient, compliant, and future-ready pharmaceutical facilities.

  3. Selecting A Platform Filter For High Concentration mAbs 4/9/2025

    Read more about how Fujifilm Diosynth Biotechnologies evaluated a prime filter with challenging simulant solutions and how the experimental data confirmed superior performance, which demonstrated twice the throughput.

  4. Developing A HIC Polishing Step For The Removal Of mAb Aggregates 9/28/2023

    Learn in-depth about the development of a flow-through polishing step that employs hydrophobic interaction chromatography for the elimination of monoclonal antibody aggregates.

  5. AAV Viral Titering Using Nanoplate-Based Digital PCR 7/22/2025

    Examine how nanoplate-based digital PCR streamlines AAV titering, providing faster results and greater accuracy, advancing gene therapy development from the lab to the clinic.

  6. Increasing Batch Size And Reducing Cycle Times For A Biologic 8/5/2025

    JHS partnered with a global pharma company to optimize biologic production, increasing output by 50% and reducing batch release times by up to 30%.

  7. Injection Site Reaction Screening Methodology 6/6/2025

    Optimize drug formulations for solubility at physiological pH to reduce injection site reactions, enable high-concentration dosing, and enhance patient comfort and compliance.

  8. Use Of Reconstructed Tissue And 3D Printed CT-Based Nasal Casts 7/3/2025

    Reconstructed nasal epithelium and CT-based 3D nasal casts provide more predictive, physiologically relevant models for assessing nasal drug delivery, improving accuracy in formulation development.

  9. Case Study: ThioBridge™ Conjugates 4/14/2025

    Discover how Abzena’s ThioBridge™ technology is enabling the next generation of stable, scalable, and clinically advanced ADCs through site-specific conjugation.

  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.