2005 Process Analytical Technology (PAT) Workshop

Process Analytical Technology (PAT): A One-Day Workshop Organized and Sponsored By the Council for Chemical Research
December 13th, 2005
Center for Advanced Research in Biotechnology (CARB), Rockville, MD

Process Analytical Technology (PAT) is an FDA initiative whose goal is to control and

understand the manufacturing process. It is a system for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes. PAT’s goal is to design and develop processes that can consistently ensure a predefined quality at the end of the manufacturing process: quality by design. PAT tools include multivariate data acquisition and analysis; modern process analyzers; analytical chemistry tools; process and endpoint monitoring and control tools; and continuous improvement and knowledge management tools.

The Council for Chemical Research is organizing a one-day workshop on PAT that will bring together participants from the pharmaceutical and chemical industries. The objectives of this oneday workshop are:
• To educate chemical industry participants on PAT;
• To educate pharmaceutical industry participants on similar activities in the chemical
industry;
• To identify specific opportunities for cross-industry collaborations that can yield concrete
and mutually beneficial results;
• To provide opportunity for participants to interact and network with colleagues from
another industry who may have overlapping interests;
• Identify research needs and wish lists of technology solutions.

The workshop’s keynote and plenary speakers are:
Chris Watts (FDA) – Keynote
Paul McKenzie (Bristol Myers-Squibb) – Plenary
Craig Snook (Dow Chemical) – Plenary
Gerry Migliaccio (Pfizer) – Plenary
Chet Mroz (Kirkpatrick Assoc., retired from ABB) – Plenary

BREAKOUTS
Four facilitated breakout sessions are planned, during which participants will be able to identify
areas for cross-industry collaboration.
• On-line measurement of process quality and performance using new instrumentation
and measurement tools, such as near-infrared, vibrational, acoustical and X-ray
spectroscopy
o Leaders: Gary Allan (Bayer), Joseph Andrisani (DuPont), John Helferich (Master
Foods), Mel Koch (University of Washington).
• Chemometric approaches (multivariate statistics, pattern recognition)
o Leaders: Steven Brown (University of Delaware), Satish Mehta (Eastman
Chemicals), Brandye Smith-Goettler (Glaxo Smith-Kline).
• Real-time data and information management systems for process control:
o Leaders: Kelsey Cook (University of Tennessee), G.K. Raju (Light Pharma), Bob
Whitaker (Shell).
• Knowledge development through modeling and process validation:
o Leaders: Jason Dickens (Glaxo Smith-Kline), San Kiang (Bristol Myers-Squibb),
Russell Rhinehart (University of Oklahoma), Joe Salvo (General Electric).

PROGRAM SCHEDULE:
Tuesday, December 13
• 8:00 - 8:30 am Registration and continental breakfast
• 8:30 - 8:45 am Opening remarks
• 8:45 - 9:30 am Keynote – Chris Watts
• 9:30 -10:00 am Plenary I - Paul McKenzie
• 10:00 - 10:30 am Break
• 10:30 - 11:00 am Plenary II - Craig Snook
• 11;00 - 11:30 am Plenary III - Gerry Migliaccio
• 11:30 am - 12:00 pm Plenary IV - Chet Mroz
• 12:00 - 1:00 pm Lunch
• 1:00 - 3:00 pm Breakouts with brief opening presentations (see above) and a
break
• 3:00 – 4:00 pm Reports back to the group
• 4:00 - 5:00 pm Tour of CARB GMP facility available (see below)

CARB TOUR
The Center for Advanced Research in Biotechnology (CARB) is a cooperative venture of the
University of Maryland Biotechnology Institute (UMBI) and the National Institute of Standards
and Technology (NIST). The internationally recognized research programs at CARB are focused
on the structure, function, design and evolution of biological macromolecules, and rely on both
theoretical and experimental approaches. The 2005 expansion of UMBI at Shady Grove will
include CARB and new core facilities for insect transformation, GMP training and
biomanufacturing, plant transformation, genomics and proteomics, and structural biology.
A focused tour of the new GMP facility is planned.

WORKSHOP ORGANIZERS:
• Don Anthony (CCR)
• Ellyn Beary (NIST)
• Richard Bowles (Schering-Plough)
• Randall Carter (General Electric)
• Charles Cooney (MIT)
• Pablo Debenedetti (Princeton)
• Mauricio Futran (Bristol Myers-Squibb)
• Russell Rhinehart (Oklahoma State)
• Bruce Roth (Pfizer)

MEETING LOCATION:
The meeting location is:
Center for Advanced Research in Biotechnology (CARB),
9600 Gudelsky Drive
Rockville, MD 20850
http://carb.umbi.umd.edu/

Workshop Sponsored By:
The Council for Chemical Research
202-429-3971
ccrmail@ccrhq.org
The Council for Chemical Research
1730 Rhode Island Avenue
Suite 302
Washington, DC 20036