Outsourced Pharma App Notes & Case Studies

  1. Stability Screening For Colloidal Stability: Diffusion Interaction Parameter Thermal Shift Assay 4/28/2025

    Colloidal stability is one of the most important properties to control due to the propensity for biopharmaceuticals to aggregate and the subsequent potential to severely affect the drug's efficacy and patient safety.

  2. Manufacturing With A Highly Potent API For An Ophthalmic Indication 1/9/2024

    Review this approach to the manufacture of a nano-milled suspension of loteprednol etabonate intermediate, encompassing the entire product development spectrum and repeat client engagement.

  3. Real-Time Monitoring Of Solvent Clearance By TFF In The ADC Process 6/13/2025

    Raman spectroscopy revolutionizes ADC manufacturing by enabling real-time monitoring of solvent clearance. Discover how it enhances process control, ensures regulatory compliance, and supports the production of high-quality therapeutics.

  4. Why Cell Line Screening Is Crucial For Successful CDC Assay Development 4/28/2025

    In developing a CDC assay for therapeutic mAb characterization or QC release testing, in addition to selecting a target cell line that expresses the mAb ligand, consideration should be made to the expression of CRPs on the cell surface.

  5. Optimizing Virus Bank Manufacturing 8/16/2024

    Gain insight into two cases where clients were enabled to overcome obstacles during virus bank manufacturing.

  6. Reducing Risk And Timelines In Cell Line Development 3/25/2025

    Accelerate your biologic development by adopting faster, more reliable clone selection methods that reduce time and resources while improving the likelihood of identifying stable, high-producing cell lines.

  7. SAP S4HANA Implementation: Commissioning, Qualification, And Validation 2/20/2024

    Explore how CAI helped one company navigate complications when implementing SAP and how new solutions are being developed, validated, and implemented to establish this new global ERP system.

  8. Analytical Procedure Development Following ICH Q14 7/23/2025

    Review how the new ICH Q14 guidance and AQbD principles can transform analytical method development into a more efficient, robust, and regulatory-ready process.

  9. Cell-Free Modeling Approach For Efficient Cell Culture Monitoring 6/14/2024

    Learn about a novel cell-free modeling method for the efficient monitoring of cell cultures that has significant advantages over traditional approaches.

  10. Understanding Technology Transfer In Pharmaceutical Contract Manufacturing 10/16/2024

    Technology transfer is a crucial process in the pharmaceutical industry, ensuring drugs developed in labs can be manufactured consistently at scale.