Advances in Downstream PAT for Biologics, Vaccines, and Gene Vectors



Tue, Aug 23, 2022 11:00 AM EDT Advanced PAT tools such as RT–MALS offer in-depth characterization of biological molecules and nanoparticles to help optimize manufacturing processes.

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Event Overview:

Rapid process development and scale-up of novel complex drugs, as well as reliable unit operations during commercial production, require advanced PAT tools, capable of providing timely feedback on product attributes. Real-time multi-angle light scattering (RT-MALS) determines key biophysical product attributes, including molar mass, particle size and particle concentration. These attributes are further indicative of quality attributes such as titer, aggregation and full-empty ratio, and may be used for process control as well as quality monitoring.
This webcast will review the principles, capabilities and limitations of RT-MALS, and then present case studies covering downstream processing (DSP) of viral vectors, proteins and polysaccharides, as well as formulation, production and purification of lipid nanoparticles.

Key Learning Objectives:

  • How RT-MALS measures biophysical product attributes including molar mass, size, aggregation, titer and AAV empty-full ratio
  • How RT-MALS integrates with processing equipment such as FPLC, TFF, reactors, homogenizers and microfluidic LNP formulation systems
  • How RT-MALS optimizes DSP control by monitoring properties of the product, rather than of the process

Who Should Attend:

  • Downstream process development scientists in need of real-time analysis to accelerate development time and minimize off-line sample analyses
  • PAT technologists exploring the latest methods for DSP product attribute monitoring
  • Manufacturing engineers designing PAT-ready production facilities


Dan Some, Ph.D.
Principal Scientist
Wyatt Technology Corp.

Dr. Daniel Some is Principal Scientist at Wyatt Technology Corp., where he contributes to product and application development as well as scientific and technical marketing. Currently he leads Wyatt’s program for commercializing real-time MALS PAT products. In the past he directed Wyatt’s efforts in instrumentation to characterize biomolecular interactions. Dan studied undergraduate physics at the Technion - Israel Institute of Technology and obtained his Ph.D. in physics from Brown University, then carried out postdoctoral research at Los Alamos National Laboratory and the Weizmann Institute of Science. Prior to joining Wyatt he was involved in defense technology and the development of processed wafer inspection tools for the semiconductor industry.

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