OP White Papers - random

  1. 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.

  2. Tailoring Viral Clearance Study Design 3/4/2026

    Viral‑clearance studies need phase‑appropriate design, strong virus stocks, modality‑specific risk assessment, and alignment with evolving regulations for reliable safety outcomes.

  3. Advancing Nanomedicine Production With Flow Manufacturing 5/6/2026

    Learn how flow manufacturing enables scalable, reproducible nanomedicine production with tighter control, consistent particle quality, and smooth lab-to-commercial scale‑up.

  4. The Benefits Of Incorporating Lean Methodologies Into Project Management 8/20/2024

    Delve into the core principles of lean project management and explore how these principles can be integrated with traditional methods to enhance project outcomes.

  5. Mammalian Cell Line Development 3/26/2026

    Explores how modern cell line engineering boosts speed, stability, and scalability across biologics, with practical insights to cut risk and improve readiness for downstream development.

  6. Science With Purpose: Advancing Sustainability In Biopharma Testing 6/9/2026

    Learn how biopharma labs are cutting animal use, energy, and paper waste while maintaining GMP compliance — with specific data on 85% labor reductions and 1 ton of CO2e saved annually.

  7. (Cross-) Contamination Control Through Effective Equipment Cleaning 5/6/2026

    Discover science-driven cleaning strategies that reduce cross-contamination, enable safe multiproduct manufacturing, and support faster, flexible GMP changeovers.

  8. Handling Protocols: Key Considerations In The Highly Potent API Market 5/12/2025

    Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.

  9. AAV-Based Gene Editing For Huntington's Disease 10/28/2025

    LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.

  10. Competing Through Complexity: Models To Manage Mature Products 7/6/2026

    As patented drug revenues drop from 23% to just 10% by 2034, biopharma leaders need a clear framework for matching mature product strategy to their organization's operating model and risk appetite.