Insights On Downstream Manufacturing

  1. A Strategy To Convert A Single Column Chromatography Process To PCC 10/13/2026

    Periodic countercurrent chromatography can raise resin utilization without specialized instruments. A breakthrough study on a Protein A column shows how a standard single column method can be converted.

  2. Endotoxin Control In The Process Development Lab 10/13/2026

    Endotoxin control in E. coli fermentation depends on effective removal, purification, and NaOH cleaning strategies, with risks evolving as manufacturing progresses.

  3. Purification Process Development Of Plasmid DNA For Gene Therapy 10/13/2026

    Filter grades, precipitation, membrane cutoffs, and anion exchange formats are compared for purifying supercoiled plasmid DNA, with purity results that show how much each step contributes.

  4. Strategies To Accelerate Gene Therapy Process Development 10/13/2026

    Gene therapy developers are accelerating timelines with platform approaches, DoE, stronger development-manufacturing alignment, and PAT tools to reach late-phase manufacturing faster.

  5. Advancing Parenteral Manufacturing: The Role Of The RTU Container 10/12/2026

    Presterilized vials, syringes, and cartridges reshaped aseptic fill-finish around small batches and multi-format lines. Regulatory fit, material choices, and high-speed filling will define where the technology goes next.

  6. Transitioning mRNA Production To cGMP Requires Early Process Engagement 10/9/2026

    Early choices in capping strategy, IVT conditions, raw materials, and downstream design shape yield, cost, and quality in mRNA manufacturing, and can determine whether a cGMP campaign succeeds.

  7. An Automated Cell-Processing Platform For MSC Harvest 10/7/2026

    Discover closed, automated harvest, formulation, and dispensing of umbilical cord MSCs at commercial scale, with data on viability, recovery, and filling precision, including single runs.

  8. Purification Of Antibodies With Nuvia™ wPrime 2A Media, A Scalable Hydrophobic Weak Anion Exchange Resin 10/5/2026

    Discover how mixed-mode AEX-HIC resin in flow-through mode optimizes downstream mAb purification, lowering aggregate levels to 0.7% with high monomer recovery.

  9. Demonstrating Process Fit With A Single-Use TFF System 10/2/2026

    A facility-fit constraint challenged the transfer of an ultrafiltration process to a new site. Learn how engineers increased membrane loading by 50% while maintaining performance.

  10. A More Controlled Approach To Chromatography Scale-Up 10/2/2026

    Scaling chromatography from development to manufacturing can introduce equipment and process variability. Precise flow control, PAT, and system-level engineering help maintain consistency, improve process control, and optimize capacity.