Insights On Downstream Manufacturing

  1. De-Risking The Transition From Vial To Drug-Device Combination Product 7/25/2025

    When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.

  2. Normalized Data In Microbial Continuous Monitoring 7/24/2025

    Learn how EU GMP Annex 1 (2022) redefines cleanroom air monitoring standards and emphasizes continuous viable sampling in Grade A and B environments to ensure aseptic integrity and compliance.

  3. Demonstrating A Modular Selectivity With A Weak AEX-HIC Resin For Achieving High mAb Purity And Recovery In A Downstream Process 7/16/2025

    Learn how a scalable multimodal resin with adjustable selectivity was employed to design an efficient mAb purification process in a flow-through mode.

  4. Analytical Strategies For Impurity Control In Antibody-Drug Conjugates 7/16/2025

    Antibody-drug conjugates (ADCs) combine antibody targeting with potent cytotoxic payloads to treat resistant cancers, but their complexity requires phase-appropriate analytical strategies.

  5. Expanding Manufacturing Of Purification Resins To Align With Customer Demands 7/15/2025

    Discover how scaling up processes and building out facilities has allowed for end-to-end solutions that meet customer requirements for both supply and quality in their production lines.

  6. Ensuring Quality, Driving Customer Confidence 7/15/2025

    How does quality assurance help drive scientific progress? A 30-year veteran shares her story of supporting customer needs and the development of groundbreaking new therapeutics.

  7. An Innovative Approach To High Aggregate Challenges 7/14/2025

    In this webinar, hear from a technical specialist on addressing the challenges with antibody aggregates and process related impurity removal using a new high performance chromatography resins

  8. Elevating Downstream Process Development With Real-Time Data Monitoring 7/11/2025

    Learn how real-time monitoring with PAT enhances process control, shortens development timelines, and supports the shift toward continuous manufacturing in biopharmaceutical production.

  9. Enhancing Viral Clearance Prediction And Process Optimization 7/11/2025

    MockV technology enables early, in-house viral clearance assessment, helping biopharma developers improve process robustness, reduce costs, and enhance safety before GMP manufacturing begins.

  10. Balancing Speed, Quality, And Digital Transformations 7/11/2025

    Explore how CDMOs can leverage strategic agility, scale flexibility, and overcome challenges to drive success in a rapidly evolving pharmaceutical landscape.