Efficient sharing of best practices at Aseptic 2015
by: Ryan Hawkins
In 2007, I attended my first barrier isolator conference, having been tasked by Cook Pharmica to select and design a path toward deploying a fill-finish facility expansion. Although we began this project with extensive aseptic processing experience, this particular expansion would be our first using barrier isolator technology. Fortunately for us, the program included several case studies from users that had been down the road we were planning to take. Their experiences provided us insights into how they organized around the project, what worked well and what did not work so well.
In one particular presentation, the speaker described a case study involving a fully-integrated, isolated syringe filling line. This served as a very useful reference guide for our remaining work ahead. I had the opportunity to engage directly with the speaker, who generously answered my questions after the presentation. I gained even more knowledge by also participating in a discussion group, which was part of the program, talking about best practices and technology for getting materials in and out of the isolator.
Throughout the conference, I was immersed in constant dialogue with subject matter experts on topics across the equipment lifecycle, including design, project management, qualification, and operational considerations. With all of these touch points and the other 10+ presentations, I remember thinking this conference was the most efficient way possible to understand current trends, best practices, regulatory perspectives and new barrier technology. In the end, I gained some much needed perspective regarding how things need to come together to effectively design and operate barrier isolators!
I have been an active conference participant ever since, despite our project having been long since completed, and each year I find it a great opportunity to learn and contribute knowledge with industry peers who are facing similar challenges. With the 2015 ISPE Aseptic Processing Technology Conference in Baltimore, MD, fast approaching, I’m looking forward to hearing and seeing the short but efficient two-day sharing cycle all over again.
I’m eager to hear leading expert Jeffrey Maynard of Core Reliance, LLC’s presentation, Recommended Approaches for the Critical Impact Decisions of an Isolator Procurement Project, and James Drinkwater of Zeil’s, Designing a Next Generation of Biologicals Filling Isolator Using Learning from Case Studies.
Each year, I leave the conference with relatable information and case studies to help navigate our team through problems and projects at all phases. I expect the 2015 conference will provide even more insight; especially with the interactive industry panel of representatives from Amgen, AstraZeneca, Baxter, Genentech, and IPS.
I hope to see you in Baltimore, MD on 23 – 24 February. For more information on the ISPE Aseptic Processing Technologies Conference or to register, please visit the conference website.
Ryan Hawkins is the Vice President and Chief Operating Officer for Cook Pharmica, a contract biopharmaceutical manufacturer, located in Bloomington, Indiana. Beginning with Cook Pharmaceutical Solutions, followed by Baxter BioPharma Solutions, he has held positions of increasing responsibility in drug product contract manufacturing, including aseptic vial and syringe filling, automated inspection, and labeling and packaging operations. In 2007, Ryan re-joined Cook as Project Director leading the design and coordination of the Parenteral Manufacturing expansion project, consisting of over 120,000 square feet of newly developed space including two high speed filling lines under isolation and complimentary secondary manufacturing capabilities. Following his operations leadership role with the Drug Product division of Cook Pharmica, in 2012, Ryan assumed site wide responsibility for Drug Substance and Drug Product Engineering, Maintenance, Technical Services and Production. Ryan holds a BS in Biology from the University of Wisconsin-Milwaukee and an MBA from Indiana Wesleyan University.