Biogen Idec, Wyeth Biopharma Create Value from Data

Notes from the Umetrics User Group, courtesy of ARC Advisory

By Tom Fiske, ARC Advisory Group, Dedham, Massachusetts

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Over the last several decades, advances in automation and instrumentation have led to an explosion of data. Advanced analytics, such as multivariate analysis (MVA), can turn mounds of data into in-formation to address manufacturing performance. These solutions allow companies to identify relationships and acceptable, multivariate “operating envelopes.” In many cases, this information is useful for developing multivariate, causal models that support prediction of performance and qual-ity, process optimization, and on-line monitoring.

 

Advances in automation and instrumentation create a data glut. Advanced Analytics, such as multivariate analysis (MVA), can be used to turn mounds of data into information to address manufacturing performance. In addition, MVA is well suited for process analytical technologies (PAT) and quality by design, major components of the risk-based approach promulgated by the FDA.
 
The Umetrics User Group brought together numerous end-users, consultants, system integrators, and industry analysts to discuss how to improve operations through data analysis techniques

The Umetrics User Group brought together numerous end-users, consultants, system integrators, and industry analysts to discuss how to improve operations through data analysis techniques. Biogen Idec has been using statistical process control (SPC) systems for commercial and clinical cam-paigns since 2004. The rollout of Umetrics’ SIMCA Batch On-Line (SBOL) allowed the company to monitor and better control its manufacturing processes in real-time. The company’s successful rollout of SBOL is, in large part, due to its company’s culture, talented employees, and feedback from its partners. From Biogen Idec’s perspective, the implementation and use involves several dimensions including support from top management, training, lifecycle management, and accountability.

Wyeth Biotech uses SBOL for process monitoring of media sterilization, fermentation, centrifuga-tion, filtration, purification, and bulk fill. Through its initial experience with SBOL, Wyeth learned that the best way to avoid conflict between different groups is to get buy-in from stakeholders at project inception. Consequently, Wyeth developed a comprehensive strategy to implement SBOL that includes clearly defining roles and responsibilities. For Wyeth, the benefits of SBOL include improving process understanding, documenting batch evolution, saving deviations, identifying batch contamination, and saving batches from termination.

Analytics Drive Improved Operations Decision Making

To succeed in a dynamic marketplace, pharmaceutical manufacturers constantly seek to design and build higher quality into their products and processes, meet or exceed performance targets, and im-plement continuous improvements. They collect data on anything that might be useful to identify problems and highlight opportunities for improvement. Proliferation of IT, automation systems, and analytical equipment has further encouraged the buildup of data on all aspects of the products, processes, equipment, and operations.

The key to success is not to distribute more data, but to analyze the data and distribute timely in-formation. Staying competitive means transforming plant data into information and making that information available in context to all personnel involved in operations. This enables them to make better decisions that generate true value. It also means adopting methods to better monitor and con-trol processes in real time.

The growing popularity of advanced analytics software reflects the buildup of plant data. The ability to graphically present and drill down into information has become an essential capability of plant floor and business applications. Advanced analytics, such as MVA, allow manufacturers to improve their operations and competitiveness by transforming data-rich systems into valuable information to glean deeper understanding, make better decisions, and improve process monitoring and control.

The major applications for MVA include process design, offline data analysis, and online process monitoring and fault detection. In addition, the FDA has adopted a risk-based approach to promote advanced manufacturing practices within the pharmaceutical industry. Process Analytical Tech-nologies (PAT) and Quality by Design (QbD) are major components of the risk-based approach promulgated by the FDA to encourage pharmaceutical companies to adopt the latest manufacturing techniques and practices. MVA is well suited for designing quality into the process using DOE and monitoring the process by making timely measurements of critical quality parameters during proc-essing to assure acceptable end product quality at the completion of the process.

2009 Users Group Forum Highlights

The Umetrics User Group brought together numerous end-users, consultants, system integrators, and industry analysts to discuss how to improve operations through data analysis techniques. Meet-ing highlights included presentations on topics ranging from offline data analysis to online measurements and closed loop control. The session concluded with a lively integration panel discus-sion by industry experts.

Analytical Measurement Proliferation Enhance PAT Initiatives

Nouna Kettaneh and Svante Wold from NNS Consulting discussed how to use online measurements in biotech PAT. Nouna indicated that advances in optics, electronics, micro-fabrication techniques, and chemometrics usher in new developments in analytical instrumentation. More affordable, ro-bust, and reliable instruments can be operated in more demanding environments without expert supervision. Many new instruments are portable and accommodate a wide range of sample types, operate online, and approach the sensitivity and selectivity of laboratory equipment.

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