JUN 14, 2016 08:00 AM PDT

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

Speakers
  • Director of Protein Technologies, CSL
    Biography
      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
      Biography
        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.

      Abstract:

      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.
       


      Show Resources
      You May Also Like
      SEP 05, 2019 04:00 PM CEST
      C.E. CREDITS
      SEP 05, 2019 04:00 PM CEST
      DATE: September 5, 2019TIME: 7:00am PT, 10:00am ET, 4:00pm CEST PCR (Polymerase Chain Reaction) has gone through a massive evolution since its development in 1983. Besides it...
      OCT 02, 2019 11:00 AM PDT
      OCT 02, 2019 11:00 AM PDT
      DATE: October 2, 2019TIME: 11:00am PDT, 2:00pm EDT Ditch the Excel spreadsheets and manage your molecular workflows entirely in your LIMS Achieve configuration of molecular workf...
      NOV 18, 2019 07:00 AM PST
      Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
      C.E. CREDITS
      NOV 18, 2019 07:00 AM PST
      Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
      DATE: November 18, 2019TIME: 7:00am PST, 11:00am EST, 4:00pm CEWT How often do you pipette in your cell culture lab every day? Usually, we do it so often that we tend stop th...
      JUN 19, 2019 10:00 AM PDT
      JUN 19, 2019 10:00 AM PDT
      DATE: June 19, 2019TIME: 10:00am PDT, 1:00pm EDT As we develop new methods to create more biologically relevant models for research in understanding disease etiology and in...
      JUN 05, 2019 05:00 PM CEST
      C.E. CREDITS
      JUN 05, 2019 05:00 PM CEST
      DATE: June 5, 2019TIME: 8:00am PDT, 11:00am EDT, 5:00pm CEST Eukaryotic cell cultures respond to the most subtle influence. Apart from the risk of contamination, minimal chan...
      AUG 27, 2019 09:00 AM PDT
      C.E. CREDITS
      AUG 27, 2019 09:00 AM PDT
      DATE: August 27, 2019 TIME: 9:00am PDT, 12:00pm EDT Immunotherapies targeting PD-1 or PD-L1 have proven remarkably effective for treating cancer in some patients, with considerabl...
      Loading Comments...
      Show Resources