Pharmaceutical Technologist - January 2008 - (Page 25)

Newcombe and Watson improvement and real-time release. In principle, the application of in-, at- or on-line (Table 2) PATs for biopharmaceutical development offers the ability to monitor, in real time, the performance of a process step.7 Although current regulatory guidance is intended to alleviate concern among manufacturers that innovation in manufacturing and QA will result in a potential regulatory bottleneck, the perceived application of the concept within a cGMP manufacturing facility may not appear to fit comfortably with the current regulatory guidelines and recommendations outlining pharmaceutical development.8 As product quality and process performance are ensured through the design of efficient manufacturing processes, it may be argued that process validation to establish a well-defined design space, normal operating ranges, outer limits and edges of failure9 should negate the need for real-time testing. The introduction of PAT methodologies at commercial scale may also be considered surplus to requirements, and a desire to continue real-time monitoring of well-defined critical steps may suggest that the process step is not well-understood. One effective, efficient and innovative approach for biopharmaceutical manufacture is to build in QbD to reduce the need for the introduction of PATs into a cGMP manufacturing facility. Indeed, the current guidance notes state that “developing and implementing an innovative PAT system for a particular product does not mean that a similar system must be developed and implemented for other products”.8 The application of PAT may, therefore, Table 2 At-, on- and in-line measurements to determine biological, physical and chemical attributes. Measurement At-line Definition * Measurement where the sample is removed, isolated from, and analysed in close proximity to the process stream Measurement where the sample is diverted from the manufacturing process and may be returned to the process stream Measurement where the sample is not removed from the process stream and can be invasive or non invasive On-line In-line * Guidance for Industry, PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance US Department of Health and Human Services, FDA, September 2004. www.ptemagazine.com 25 http://www.ptemag.com/subscribe http://www.ptemag.com/subscribe http://www.ptemagazine.com

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Pharmaceutical Technologist - January 2008 Contents Editor's Comment News Morpheus Market Watch Lagging Japanese Drug R&D Croatia’s Innovation Integrating PAT with Biopharmaceutical Development and Manufacture Q&A

Pharmaceutical Technologist - January 2008

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