Insights On Downstream Manufacturing

  1. Controlling Complexity In ADC Formulation Development 9/9/2026

    ADC formulation development requires a molecule-specific approach that accounts for the interplay between antibody, linker, and payload, and the stability trade-offs that mAb development experience cannot fully anticipate.

  2. An Integrated Analytical Approach To Lipase Risk Management In Biologics Development 9/8/2026

    Conventional HCP testing cannot confirm whether residual lipases remain enzymatically active. Here, the authors examine why functional activity data are essential for managing polysorbate-related stability risk in biologics development.

  3. Durability Of Membrane-Based Protein Capture Device With Protein A 9/3/2026

    See how repeated caustic sanitization affected yield, impurity clearance, and microbial control across 100 protein-capture cycles, providing practical evidence for evaluating device durability.

  4. Scaling Down For Success: Optimizing Single-Use Virus Filtration For Small-Scale Bioprocessing 9/2/2026

    Automation can bring greater consistency, product recovery, data capture, and operational efficiency to small-scale viral filtration once processes are sufficiently defined, helping gene therapy developers transition beyond highly manual workflows.

  5. A CCS Is A Purpose-Built Machine, Not A Black Box: Understand The Workings 9/2/2026

    Learn how to transform your contamination control strategy into a dynamic operational framework that identifies risks and strengthens facility control.

  6. Sterilizing-Grade Filtration Of mRNA Encapsulated Lipid-Nanoparticles 9/2/2026

    Compare sterilizing-grade membrane performance at high and low pressures, including throughput, bacterial retention, and the effects of filtration on particle diameter and encapsulation efficiency.

  7. Role Of Membrane Chemistry And Filter Format In TFF 9/2/2026

    Compare hollow fiber and flat sheet TFF formats across three membrane chemistries, and see how filter selection can influence ambient-temperature UF/DF optimization, processing time, and quality.

  8. Enhancing mRNA-LNP Downstream Processing Via Single-Pass TFF 9/2/2026

    Single-pass tangential flow filtration effectively concentrates mRNA-LNPs and removes ethanol while maintaining quality. See how this approach produced LNPs with 4.2-fold higher in vitro potency.

  9. Rethinking Column Care: Why Resin Preservation Is A Lifecycle Strategy 9/2/2026

    Chromatography resin is expensive, making proper maintenance vital. A comprehensive cleaning, regeneration, and storage program protects resin longevity, reduces risks, and ensures cost-effective biopharmaceutical manufacturing.

  10. Process Intensification Of Protein A For mAb Purification 9/1/2026

    See how membrane and multi-column chromatography compare with traditional Protein A capture in productivity, cost, scalability, and performance, including results from pilot-scale membrane testing.