CASSS CE Pharm: One Attendee's Experience

“Tribal Knowledge” and other Unexpected Benefits of the U.S. Government Shutdown on a Scientific Conference

  • Washington DC. © rabbit75_fot Washington DC. © rabbit75_fot
  • Washington DC. © rabbit75_fot
  • Members of the scientific organizing committee
  • Session Chair Oscar Salas-Solano, Seattle Genetics, Inc (standing) moderating the Regulatory Session Panel Discussion. Pictured R-to-L: Ahmad Amini, Swedish Medical Product Agency, Guy Auclair, European Comissin - DG JRC and Michel Girard, Health Canada
  • Engaged participants in the Analysis of Product and Process Related Impurities Using CE Session
  • András Guttman receiving the 2013 CE Phram Award

Where were you during the U.S. government shutdown of Oct 2013? I'll always remember where I was. It was CASSS' CE in the Biotechnology & Pharmaceutical Industries Conference in Crystal City, Virginia - adjacent to Washington DC. And, I'll always remember it as one of the best conferences I've ever attended. Though the start was dubious, change and surprise can turn out to be even better than planned. You see, with our proximity to DC we hoped to have a particular emphasis on regulatory issues and were looking forward to our Keynote speaker from the FDA, Steven Kozlowski. The Shutdown threw a monkey wrench into our plan, but the need to improvise resulted in our most collaborative meeting in years.

CE Pharm strives to be a forum to bring Capillary Electrophoresis practitioners together for the exchange of ideas and collective learning through each other's experiences. The hope is not only that the program will provide invaluable information, but that the forum itself will bring together individuals with practical needs or technical problems and through discussion they will collaboratively find solutions and create partnerships. As a result, CE practitioners of all skill and experiences levels will return to their labs with new information to tackle old problems and new contacts to consult with as they encounter CE related issues in the future. Analytical labs, for years, have spoken of the value of "tribal knowledge" as it relates to their smooth operations; CE Pharm strives to take "tribal knowledge" to a more global level.

While CE Pharm's end goal is to meet the needs of the practitioner of capillary electrophoresis in the biopharmaceutical industry, this goal can only be fully met by bringing together all the players in the CE world. This includes the academic labs that push the frontiers of CE by innovating instruments designs and functionality, developing new chemistries and creating applications in new areas; the CE vendors that provide our instruments, software, kits and supplies; and finally, and equally as important, are the regulators with whom we must partner as we implement practical CE methods that meet all regulatory expectations.

On the Academic front, CE Pharm 2013 was incredibly fortunate to have Professor Norman Dovichi as a keynote speaker.

Professor Dovichi's energetic presentation struck me like electroshock therapy. For years I had been walking into the lab under the delusion I know what a CE instrument is and will be in the future. Professor Dovichi amazed the audience with many designs his lab has created over the years to address unmet needs and push the limits of CE technology and applications. Much of this innovation involved tandem CE mass spectrometry. This emphasis of CE-MS was also common to the presentations from Yannis Francois (University of Strasbourg) and Rob Haselberg (Vrije University). Dr. Francois spoke of sheathless CE-MS for the characterization of n-linked glycans of a monoclonal antibody. Dr. Haselberg compared the advantages of affinity capillary electrophoresis (ACE) and CE-MS in the characterization of a "nanobody".

As mentioned above Steven Kozlowski, M.D (FDA Director) was unable to give the keynote speech for our regulatory session due to the government shutdown. While that seems like a terrible loss, and it was, we still had a very full and diverse regulatory session. The session opened with long time CE Pharm contributor Michel Girard representing the regulatory body of Health Canada. The session also included European perspectives from Guy Auclair (European Commission) and Ahmad Amini (Swedish Medical Products Agency).

Beckman-Coulter (Sciex Separations), Protein Simple, Perkin Elmer, Polymicro Technologies, a subsidiary of Molex, Prozyme, Inc., Waters Corporation, and CMP Scientific aptly represented the instrumentation and equipment aspect of the conference. Perkin Elmer, Beckman-Coulter and ProteinSimple each provided an informative ‘lunch and learn' that enlightened participants to the range of applications their instruments support. All the vendors displayed their wares and made themselves available through the entire conference for meaningful discussion with conference attendees.

In her keynote presentation, Genentech's Stacy Ma, tied together this relationship of Industry with academic labs, vendors and regulators from a historical perspective. Dr. Ma, the 2009 CE Pharm Award winner and longtime advocate of CE, emphasized that partnering with regulatory agencies was a critical step in implementing CE for biopharmaceuticals.

Anita Szajek from the US Pharmacopeia who is USP champion of chapter <129> Analytical Procedures for Recombinant Monoclonal Antibodies presented "Results from the Round Robin Study: Size Variant and CE Methods". Another round robin study was presented in a technical workshop by Drs. András Guttman (University of Debrecen) and Sung-Ae Suhr Park (Amgen, Inc.) entitled: "Multisite N-glycan Mapping Study using Orthogonal Methods: CE and UPLC". These multisite studies are a unique aspect of the CE Pharm Conference and this was the third such study. In the past CE Pharm organizing committee and participants have facilitated multisite studies investigating the robustness of CE-SDS and cIEF between labs across the globe and have then documented the results in peer reviewed journals. The 2013 study of N-glycan mapping had enlightening results showing unique selectivities for each method and demonstrating the value of the orthogonal methods. Another benefit of the government shutdown turned out to be that the organizing committee was able to expand the focus on troubleshooting, a particular area in which the committee strives to enrich conference participants. Kudos go out to the 2013 participants, never before have I seen a more open group. The dialogue was fantastic, people with great insights, ideas and opinions, but what impressed me most was the number of times I heard, "Huh, I never looked at it that way." That mindset and the open dialogue overcame me as a co-facilitator and prompted me to shut my mouth and listen. I thought to myself, nothing could be better than this type of dialogue session and conference feedback seemed to confirm that.

Concluding Remarks
Not only did the troubleshooting session provide for lively exchange of ideas and experiences, it was pervasive throughout the meeting. In addition to traditional presentations, the CE Pharm meeting is designed to foster this type of ‘organic' discussion, whether at the breaks, poster sessions, evening reception or dinners. Both Beckman-Coulter and ProteinSimple invited participants to dinner, as they have traditionally, and it was at these dinners that I really got to know a few colleagues from other companies making friends and important professional contacts. With capillary electrophoresis, in particular, it is so nice to be able to reach out beyond the confines of my own company and seek advice based in more extensive experience. It is "tribal knowledge" at its best.



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