JUN 14, 2016 08:00 AM PDT

Rethinking the timeline required for Quality by Design studies in protein process development

  • Director of Protein Technologies, CSL
      Lou is a senior member of the CSL research staff heading up the protein chemistry purification group. He leads the high throughput purification of proteins and macromolecular assessment of proteins for research based studies in CSL Limited.
    • Bioprocess Scientist, Merrimack Pharmaceuticals
        Bill Flaherty is an associate scientist within the Process Development group at Merrimack Pharmaceuticals where he is charged with developing methods and characterizing molecules as well as supporting Process Development and Manufacturing. Prior to this role, he worked for eight years at first Wyeth then Pfizer, contributing to analytical development efforts across their pipeline. Bill is a WPI grad with substantial experience in assay development across multiple research areas and validation in the GMP environment.


      DATE: June 14, 2016
      TIME:  8am Pacific time, 11am Eastern time

      Improving systems for rapid small-scale protein purification and analysis in order to obtain sample numbers for statistically significant analyses required for the selection of lead candidate molecules is an ongoing challenge. Here we explore how Quality by Design (QbD) timelines can be accelerated through the high-throughput miniaturization of purification workflows and subsequent characterization of relevant proteins. Using nontraditional sample preparation techniques and high-throughput capillary electrophoresis permit/enable/facilitate small scale protein purification-- and analysis in days what typically would take weeks with alternative methods. These advantages over traditional approaches enable you to experimentally determine an immense potential design space for process development, leading to increased yield and product quality. 
      During this webinar, you will hear Louis Fabri discuss how the use of a small scale protein purification robotics platform coupled with optimized transient expression clones reduced the time to produce and purify antibodies (mg quantities), providing an effective process to screen a diverse repertoire of proteins from which lead candidate molecules can be selected. 

      The JANUS BioTx Workstation provided tenfold advantages in throughput, over higher scale Fast Protein Liquid Chromatography platforms while generating data predictive of those larger scale workflows.  Utilizing transient expressions systems (e.g. Expi293), clarified supernatants could be directly transferred to the liquid-handling robotics platform to rapidly purify proteins through multiple stages of chromatography.  
      Bill Flaherty will explore the use of a high-throughput platform to quantitatively characterize protein molecules for pharmaceutical process development, specifically to assess protein conjugation and purity during the purification and construction of a pharmaceutical target.  He will discuss how LabChip® microfluidics technology alleviates the bottlenecks from small-scale purification workflows.  Unlike more traditional methods, high-throughput capillary electrophoresis (micro-CE or CE-SDS) workflows offer rapid and automated analytics needed to adequately address the sample numbers required for QbD studies.  High sensitivity and resolution of the LabChip assay allow for analytical separation of process impurities distinguishable by only a few kilodaltons; permitting accurate conjugation efficiency, product quality assessment and ability to reconcile process changes that could not be achieved by alternative traditional methods.

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