Expert Insights On Downstream Bioprocessing

  1. End-To-End mRNA DS And DP Manufacturing Processes 7/10/2024

    This article demystifies the manufacture of mRNA encapsulated in lipid nanoparticles across unit operations for plasmid linearization, drug substance (DS) manufacture, and drug product (DP) manufacture.

  2. Does Single-use Seem Daunting? Try Starting With Standard Assemblies 7/8/2024

    You might not need to outfit your whole facility to take advantage of single-use technology. Assemblies offer a straightforward path to standardizing equipment.

  3. Using The ADKAR Model In Biopharma Change Management 7/8/2024

    Biopharma companies dedicated to continuous improvement are the ones that dominate their market sector. Using the ADKAR model of change management can help.

  4. Making Cancer Vaccines Is Complex; New Platform Guidance Could Help 7/3/2024

    FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.

  5. Strategies To Tackle CAR-T Product Challenges 6/24/2024

    This article describes strategies for scaling up production of CAR-T products, including the hub model, bedside model, innovation of process strategy, and more.

  6. How Mechanistic Modeling Eases Wet Lab Dependence 6/20/2024

    Mechanistic modeling mimics process steps in a computational environment, thereby substantially reducing the dependence on physical experiments.

  7. Does Flow Play A Role in Protein Aggregation During Bioprocessing? 6/7/2024

    We know about many factors that trigger protein aggregation, but does fluid flow itself play a part? These scientists at the University of Leeds are working to find out.

  8. Points To Consider For Assessing Lipid Quality For Lipid Nanoparticle Manufacturing 5/29/2024

    Lipid nanoparticles have generated a ton of buzz, but they pose risks that, perhaps, industry and regulators have not taken seriously enough so far.

  9. 7 Steps To Accelerate Biopharma Manufacturing Processes 5/21/2024

    Now more than ever, manufacturing capability can make or break success. To navigate the challenges, small biopharma companies must adopt these strategic approaches.

  10. How Advanced PAT Aids Quality By Digital Design In mRNA Manufacturing 5/15/2024

    QbDD is an improvement over the QbD paradigm. Here, computational models are used to characterize, monitor, control, and improve manufacturing processes.