Insights On Downstream Manufacturing

  1. Establishing A Container Closure System — Engineering For Integrity 8/31/2026

    CCS design in aseptic manufacturing involves more than component selection. This article examines how elastomeric closures, barrier configurations, component formats, and plunger placement affect integrity and line performance.

  2. Start Packaging Development Early: De-Risk Before You Build 8/31/2026

    When packaging development follows fill/finish line selection rather than informing it, teams face avoidable retrofits and delays. This article examines why earlier alignment changes outcomes.

  3. 3 Decision Domains Shaping Sterile Drug Product Success 8/28/2026

    In sterile development, the decisions with the greatest downstream consequences are rarely recognized as such when they are made. Examine how these choices shape program outcomes across the lifecycle.

  4. Enhancing Bispecific And Trispecific Antibody Purification Using Mixed-Mode Chromatography 8/27/2026

    Mixed-mode chromatography leverages dual interaction mechanisms to clear mispaired species and aggregates, elevating multi-specific antibody purity above 99%.

  5. New Facility, New Filling Line: A Sterile Fill-Finish CDMO 8/27/2026

    A new sterile fill-finish facility and advanced filling line expand capacity, flexibility, and quality oversight, helping accelerate the path from clinical development to commercial supply.

  6. Don't Intensify Blindly: Preventing Fouling And Restoring Performance With Targeted Cleaning Of Protein A Resins 8/27/2026

    Protein A chromatography intensification can increase productivity, but it may also affect process robustness. Explore key tradeoffs, operational challenges, and practical considerations.

  7. Optimize Process Performance And Maximize HCP Removal 8/27/2026

    Compare filtration strategies and explore how filter selection affects host cell protein removal, processing efficiency, and the balance between impurity clearance and filtration performance.

  8. Build Process Robustness Through Deeper Process Understanding 8/27/2026

    Compare statistical, mechanistic, and machine learning approaches to understand their principles, requirements, and future potential for improving efficiency and supporting better decisions.

  9. How To Define, Monitor, And Hit Critical Endpoints 8/26/2026

    Improve UF/DF repeatability by defining clear concentration and diafiltration endpoints, matching them with appropriate measurements, and applying real-time in-line analytics to reduce variability.

  10. Chromatography Training Series - Fundamentals Of Ion Exchange Chromatography 8/24/2026

    Explore how protein charge, pH, buffer selection, and resin chemistry influence purification performance, and gain practical insights into process development and optimization.