The abstract of this lecture
It takes on average 12 years to bring a new pharmaceutical product to market at a cost in
excess of $1 Billion
While this is without doubt a staggering figure it looks set to increase as
new treatments become more complex and focused in nature.
This has lead to products which
require greater development resources and treat a smaller range of symptoms.
quality procedures, designed to protect patient health, have to date demanded a quality by lab
test approach to production
which leads to inefficient processing, delays in product release
and large amounts of documentation.
Recent initiatives by the Food and Drugs Administration and the industry itself have asserted
solution is to change from a quality by ‘lab test’ to a quality by design approach to
development and manufacturing.
The use of Process Analytical Technology (PAT) is seen as
key to better understand the complex nature of new products, current manufacturing processes
and offers a mechanism by which
processes can be controlled to maintain quality rather than
final product testing.
One major barrier has been the lack of integrated solutions and a data standard to pull together
the many different facets required to provide a PAT solution :
A common platform to integrate
multiple analytical instruments, data synchronization, storage of data in a common format and
the ability to pass or extract data to third party platforms.
So what is being done to move things forward?
We need a new standard for Analyzer Interfaces.
A standard which
• Provides a consistent way to create interfaces
• Allows the interfaces to be reused by multiple software packages
• Desired Characteristics
• Define the notion of analyzer class (Spectrometer, Liquid Chromatograph, Particle size, Mass Spectrometer, …)
• Within a class should be entirely data driven (no code changes In the base platform)
• Needs to support high data volumes on a Network (imaging).
OPC Foundation Announces
Support for Analyzer Devices Integration
into OPC Unified Architecture Platform
Press Release dated January 12, 2008
The OPC Foundation has announced support for Analyzer Devices Integration into the OPC Unified Architecture.
The OPC Foundation has created a working group composed of end-users: Abbott , GSK ,Pfizerand vendors: ABB, Mettler-Toledo, Umetrics representing both Process Analytical Technology (PAT) and laboratory industries to develop the information model for all analyzer devices facilitating plug-and-play multivendor interoperability.
The Analyzer Device Integration (ADI) Working Group will develop a common method for data exchange and an analyzer data model for process and laboratory analyzers.
The model will be developed as a logical extension of the OPC UA specifications. Analyzer integration based on standards will offer unique opportunity in Data Management & Integration for solutions such as Process Analytical Technology (PAT).
|Member list of the work group
• Arla Foods
• BR&L Consulting
• Kaiser Optical Systems
• Malvern Instruments
|• Mettler-Toledo Autochem
• PC Foundation
• Software Toolbox
• Sympatec GmbH
• Thermo Fisher Scientific
|Time table for the common platform
February 2008 – kickoff
April 15-17, 2008
June 24-26, 2008
August 12-14, 2008,
September 23-25, 2008
November 4-6, 2008
December 9-11, 2008
December 2008 -planned draft release
June 2009 –planned first release
Reference implementation Q1