OP White Papers - random

  1. Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars 2/9/2024

    The presence of ADAs can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.

  2. Recommendations For Successful IND Approval Of RNA-LNP Drugs 8/22/2023

    The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.

  3. Quality By Design (QbD) For Biologics From A CDMO Perspective 2/18/2025

    Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

  4. Tablet Manufacturing Technologies For Solid Drug Formulation 4/2/2025

    Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.

  5. The Advantages Of A Blended Learning Approach In Operator Training 5/30/2024

    Explore blended learning and its advantages over traditional operator training methods, which often reduce training to a repetitive but necessary checklist of reading and acknowledging procedures.

  6. A Scalable Single-Use Two-Step pDNA Purification Process 3/6/2024

    Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.

  7. 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.

  8. Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization 8/25/2023

    There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.

  9. Accelerated Development Of Solid Oral Dosage Formulation For IND Submission 12/11/2024

    This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.

  10. Adapting A rcAAV Assay For Commercial Manufacturing 9/16/2024

    Better understand the intricacies of AAV triple transfection and how advances in vector production and cell line optimization are enhancing gene therapy.