OP White Papers - random

  1. Flexibility In Drug Development: From Tactical Response To Strategic Imperative 4/6/2026

    Build flexibility into your drug development strategy to navigate change effectively, maintain momentum, and drive successful outcomes across every stage of the lifecycle.

  2. 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.

  3. Fill-Finish Contract Manufacturing: Trends, Challenges, And The Future 9/16/2025

    See why it's important to partner with a CDMO that’s investing in advanced sterile fill-finish capabilities to meet the demands of complex biologics, gene therapies, and mRNA-based products.

  4. USP <665> Becomes Official On May 1, 2026. Are You Ready? 2/24/2026

    With USP <665> becoming official on May 1, 2026, proactive preparation is essential to ensure compliance and prevent delays, regulatory observations, or supply chain disruptions.

  5. 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.

  6. What FDA CRLs Reveal About Method Validation 4/14/2026

    FDA rejection letters reveal validation failures are structural, not technical. Weak lifecycle oversight, robustness, and documentation continue to delay approvals despite clear guidance.

  7. 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.

  8. Achieving Rapid, High-Titer Expression For Next-Generation Biologics 3/5/2025

    This advanced cell line development technology overcomes production challenges related to the expression and scalability of complex biologics.

  9. Facilitate Handling Of Bulk Powders With Dry Granulation 8/11/2025

    Handling bulk powders in manufacturing presents serious challenges—from unpredictable caking to safety risks—that can disrupt workflows. Discover solutions to streamline operations and protect your team.

  10. AI Implementation To Enhance Quality 2/11/2025

    Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.