By Terry K. McMahon, CONTROL Columnist
THE FUNDAMENTAL axiom of the Scientific Method is known as “Occam’s Razor” after the 14th Century English friar who first enunciated it. Its corollaries are many, but, in essence, its message is: the simplest way is the best way. We now have a basis for evaluating competing theories. The theory whose logic is straightest and whose assumptions are fewest is the better one, always provided that it explains the observable data. The quotation seems obvious to us now, but only because it is integral to our scientific culture. It was not obvious in the 14th Century.
Tim Moore, manufacturing VP at Genentech in South San Francisco, invoked Occam’s Razor in opening the recent 11th annual Pharmaceuticals Automation Roundtable (PAR). Moore urged the assembled automation professionals to stay focused on simple logic that adds value. He also cited a parallel imperative: the continuing development of automation personnel.
The South City gathering is one of the larger ones, and it attracted 28 attendees representing 11 pharmaceuticals manufacturers. They were: Abbott Laboratories, Alcon Laboratories, Amgen, Biogen-Idec, Bristol-Myers Squibb, Genentech, Eli Lilly, NovoNordisk, Pfizer, Roche and Talecris (formerly Bayer).
For the first time in years, the event was attended by both founders, Dave Adler and John Krenzke of Eli Lilly, who co-hosted the first roundtable in 1994. Jim Craib, of Genentech, chaired the first day’s discussions and JoAnn Yates, also of Genentech, chaired the second day, as well as the site visit to Genentech’s expanding complex in Vacaville.
The roundtable’s discussion leaders were: Kate Waters, of Genentech, who talked about architecture/infrastructure; Greg Bischoff, of Roche, who spoke about system obsolescence/transition; John Krenzke, of Lilly, who presented alarm management; Ed Lynch, of Pfizer, who delivered MES (Part 1); Pat Coddington, of Abbott, who presented MES (Part 2); Joe Musiak, of Biogen-Idec, who talked about change control; and Jorge Linares, of BMS, who spoke about modular design.
Each discussion ran for 75 minutes. The leader framed the questions in an introductory presentation followed by comments from all 11 companies relative to their practice and experience. When the opening topic turned to automation’s inevitable overlap with corporate IT and system security, for instance, one participant noted that the threat from an internal disgruntled employee is much greater than that from an outside hacker. Lively discussion followed.
Genentech’s Vacaville complex is more than doubling its production capacity. The original plant, with 12 12,000-liter bioreactors, was the site of PAR5 in November 1998, just prior to its formal start up. The expansion plant, with eight 25,000-liter bioreactors, is scheduled to start up in 2009. Herceptin, Rituxan and Avastin, all promising cancer therapies, are produced at Vacaville.
The program at the Vacaville facility included four 20-minute tutorials plus a 20-minute tour of Manufacturing and Central Utilities. The tutorials were:
- Systems Integration: DCS, MES, ERP, Batch History and Lot Release
- Advanced Data Historian Tools for Process Monitoring
- Advanced Querying Tools for Batch Information
- DCS Architecture & S88 Process Model Implementation
No formal minutes or notes are ever taken at this conference. What happens at PAR, stays at PAR. However, these proceedings are wide open to any pharmaceutical/biopharmaceutical manufacturer willing to share its experiences and best practices. If you’re not participating, you’re probably missing an important opportunity to measure and maintain state of the art practice in manufacturing automation. Next year, Biogen-Idec has offered to host.
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