OP White Papers - random

  1. Operational Success By Strategic Investment 1/22/2026

    Explore how infrastructure, equipment strategy, and advanced technologies shape a more reliable path for scaling sterile injectable programs.

  2. Scaling With The Client In Mind: A Customer-Centric Approach To Project Scale-Up 1/22/2026

    In today’s fast-moving biopharma landscape, scaling from clinic to commercial takes more than expertise. See how collaboration can transform scale-up and drive confident progress

  3. Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap 7/23/2025

    As biopharma complexity grows, flexible CDMOs are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.

  4. Support Of Scale-Up And Technical Transfer Through Understanding Equipment 10/16/2024

    See how our expertise in formulation and process development can ensure a seamless scale-up from laboratory to full-scale production of lyophilized injectable products.

  5. ISO 21973: How To Ensure Full Compliance Throughout Every Step Of The Journey 6/28/2024

    Learn how ISO 21973, a vital standard for ensuring safe and reliable transport of cell and gene therapies, enhances supply chain efficiency and mitigates risks for the regenerative medicine industry.

  6. 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.

  7. Why Biopharma Breakthroughs Aren't Moving The Market 10/20/2025

    Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.

  8. Revolutionizing Drug Discovery From "Undruggables" To AI 6/10/2024

    Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.

  9. Regulatory Considerations For Excipients Used In Lipid Nanoparticles 8/15/2024

    Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

  10. Maximizing rAAV Production Efficiency: Introducing Pro10™ Cell Line 3/13/2024

    This HEK293-derived, animal component-free suspension cell line forms the foundation of a scalable, robust platform process that accelerates AAV manufacturing.