OP White Papers - random

  1. Mastering Modern Challenges In Drug Development Through Expert Technology Transfer 2/12/2026

    Drawing on experience from hundreds of successful transfers, our experts recognize that informed decision-making at critical junctures can determine whether a program maintains momentum or loses it.

  2. Process Development For Lyophilized Products 10/16/2024

    Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.

  3. Strategic Hiring For Scalable Success 1/22/2026

    Discover how a people-first talent strategy, purpose-driven culture, and cross-functional collaboration come together to support scalable growth and operational excellence in commercial manufacturing.

  4. Engineering Reliability In Cell Therapy Manufacturing 2/3/2026

    A cell therapy manufacturing model built on precision planning, digital execution, lifecycle‑ready CMC systems, and transparent collaboration to achieve high reliability and reduce variability across programs.

  5. Navigating The Complexities Of Pre-Filled Syringe Manufacturing 9/4/2025

    Drawing on our extensive expertise in sterile injectables (SI), here, we highlight practical strategies and proven solutions designed to help navigate challenges and support the reliable, scalable production of high-quality PFS therapies for patients worldwide.

  6. Guiding Principles For Process Development And IND Readiness 7/25/2025

    Observe how a milestone-driven risk management strategy streamlines cell therapy development, reduces uncertainty, and aligns early decisions with long-term commercialization and regulatory success.

  7. Optimizing Charge And N-glycan Profiles For CHO-Derived Fusion Proteins 9/24/2025

    Discover how structured design-of-experiment approaches can optimize charge variants and glycosylation to enhance biologics quality and therapeutic performance.

  8. 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.

  9. Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators 4/28/2025

    Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.

  10. 5 Steps To Design A Microbiological Performance Qualification For Facilities 4/21/2025
    Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.