OP White Papers - random

  1. Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements 4/8/2025

    Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.

  2. A Risk-Based Approach To Plasmid DNA And mRNA Process Development 9/23/2025

    Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

  3. Challenges And Solutions In Lyophilization Development For ADCs 12/10/2025

    Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.

  4. Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection 10/3/2024

    Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.

  5. Placing Drug Strategies On A Solid Foundation For Success 9/3/2025

    Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.

  6. Boosting CMC Regulatory Efficiency In Gene Therapy 9/30/2024

    Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

  7. Open-Label Study Assessing Relative And Absolute Bioavailability 1/26/2026

    Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.

  8. Super Short Activated CAR-T Process 1/17/2025

    Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.

  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. Leveraging Flow Chemistry 1/22/2026

    Discover how continuous processing cuts waste, improves efficiency, and supports safer, scalable reactions while helping teams meet sustainability goals and speed development.