OP White Papers - random

  1. Annex 1: Sterile Fill/Finish For Early Phase Clinical Supplies 5/5/2025

    Meeting stringent requirements for sterile fill/finish operations hinges on robust contamination control strategies, advanced isolator technology, and rigorous integrity testing to ensure patient safety.

  2. Practical Considerations For Your Process Characterization Study 5/14/2026

    Outsourced process characterization can save time, but only with the right preparation. Clear expectations around materials and data interpretation help reduce rework and strengthen confidence.

  3. ADC Manufacturing: Practices, Challenges, And The Road Ahead 6/15/2026

    ADCs are advancing quickly, but manufacturing complexity is rising just as fast. Key challenges in scale-up, regulation, and costs are reshaping how the next generation of therapies will be delivered.

  4. Leveraging Integrated Electronic Laboratory Notebook And Inventory Systems 6/15/2026

    Integrating lab notebooks with inventory and asset tracking boosts accuracy and traceability. Real-time visibility cuts errors, speeds decisions, and supports compliant, scalable pharma development.

  5. Untapped Potential In Animal Health Innovation 5/26/2026

    Animal health innovation is driving rapid market growth, fueled by rising demand and complexity, creating opportunities for advanced therapies, sustainability, and better disease management.

  6. How Confident Are You In Your Autoinjector? 2/23/2026

    As demand for self-administered therapies accelerates, autoinjectors, formally known as automated needle-based injection systems (NIS-AUTO), are playing a central role in modern medicine. 

  7. Advancing Drug Development With Optimized LC-MS/MS Bioanalysis 5/7/2025

    Explore the critical role of sample preparation optimization and the application of liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in bioanalytical method development.

  8. Phase-Appropriate Approaches To Manufacturing And Testing 3/14/2025

    Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.

  9. Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration 7/7/2025

    Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.

  10. Pharmaceutical Spray Drying – Technology And Applications 1/21/2025

    Explore the transformative potential of pharmaceutical spray drying in improving drug formulation, bioavailability, and delivery through versatile and innovative applications.