Insights On Downstream Manufacturing

  1. BPAL Case Study: Solving Downstream Purification Challenges For Partners 10/29/2026

    An aggregation-prone monoclonal antibody exposed the limits of a standard Protein A platform. A staged screening and column study tested whether tailored capture and polishing could improve recovery and purity.

  2. What Established Modalities Can Teach Us About Manufacturing In Vivo CAR-T 10/27/2026

    In vivo CAR-T manufacturing can build on established mRNA-LNP and cell therapy platforms, but requires tailored controls linking formulation attributes, targeted delivery, functional potency, stability, and scalable production.

  3. Maximize Exosome Yields Using a Chemically Defined Bioreactor Media System 10/22/2026

    See how scalable processes can improve exosome yield and recovery while maintaining critical quality attributes and supporting clinical manufacturing.

  4. Scaling ADC Manufacturing Without Compromising Quality 10/21/2026

    Moving ADC manufacturing to commercial scale alters mixing, solvent distribution, and more. Controlling these scale-dependent effects determines whether quality attributes and process performance hold.

  5. Early-Stage Viral Clearance: A Strategic Advantage In Biopharmaceutical Development 10/19/2026

    Early viral clearance work can uncover process risks, strengthen purification strategies, and support regulatory readiness for complex or less-characterized modalities.

  6. Science-Driven Risk Mitigation In Single-Use Drug Product Processing 10/16/2026

    Explore how extractables and leachables from single-use systems can affect peptide stability, as well as how science-led approaches to component selection can reduce risk throughout manufacturing.

  7. See How Fill4Sure Works 10/16/2026

    Dedicated fill lines for each needle eliminate the need to perform line splitting, minimizing the risk of fluid-path bottlenecks, cavitation for sensitive drug products, and structural weak points in assembly integrity.

  8. Improving Formulation And Aliquoting Efficiency With Mixing Solutions 10/14/2026

    Separate formulation, filtration and aliquoting add transfers and integrity tests. A single closed flowpath can improve time, yield and contamination control.

  9. Scaling A Biological Downstream Process For 30,000-L Biomanufacturing 10/13/2026

    Moving a purification process from bench to ultra-large GMP scale depends on how each unit operation is scaled, and on the equipment and supply gaps that appear along the way.

  10. Intensification Of mAb Purification 10/13/2026

    Membrane adsorbers can speed mAb purification, reduce Protein A costs, and deliver resin-like yield and purity through rapid cycling operations.