THOUGHT LEADERSHIP CONTENT

• Optimization Of AAV Production Using New Statistical Design Of Experiment

  Space filling experimental designs cover the full design space, not just its edges, and may offer a more accurate way to model response surfaces and set AAV operating ranges.

• Effective And Efficient High mAb Titer Production Methods

  Titer and timeline differences in minipool generation for mammalian cell line development, followed by fed batch performance of single cell clones across five mAbs.

• Efficient Tech Transfer For Ultra-Scale Biomanufacturing

  Biologics manufacturing is entering a fourth wave, driven by ultra-large bioreactors and outsourced production, where successful technology transfer is critical to scale, efficiency, and supply.

• Scaling A Biological Downstream Process For 30,000-L Biomanufacturing

  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.

• Intensification Of mAb Purification

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

• A Strategy To Convert A Single Column Chromatography Process To PCC

  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.

• Endotoxin Control In The Process Development Lab

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

• Characterization Of Oxygen Mass Transfer Rate (Kla)

  A response surface model reveals how agitation, airflow, and volume affect oxygen transfer (kLa) across bioreactor scales, improving scale-up predictability.

• Purification Process Development Of Plasmid DNA For Gene Therapy

  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.

• Strategies To Accelerate Gene Therapy Process Development

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

• Long-Acting GnRH Antagonist Eliminates Testosterone Surge

  Low titer limits transient transfection for AAV production. A screening design across six process parameters pinpoints which ones drive yield and how far titer can be pushed.