Process analytical scientist

Profile of a process analytical scientist/engineer Based upon onr collective experience, successful process analytical personnel have some combination of the following competencies ... 

The objective of this book is to provide both an overview and practical uses of the techniques available to analytical scientists involved in the development and application of methods for protein-based biopharmaceutical drugs. The emphasis is on considering the analytical method in terms of the stage of the development process and its appropriateness for the intended application. The availability of techniques will reveal whether or not the analytical problem has a potential solution. Then will come the question of whether or not the technique is a truly appropriate solution. The theoretical considerations behind choosing the technique may be solid. However, the practicality of the method may not hold up to inspection. 

MICHAEL LEVIN is President and CEO, Metropolitan Computing Corporation (MCC), East Hanover, New Jersey, specializing in process analytical instrumentation as well as data acquisition and control systems for tablet presses, mixers, roller compactors, and other equipment. Prior to forming MCC in 1985, he was a consultant to pharmaceutical companies such as Merck, Sandoz, and Warner-Lambert. A member of the American Association of Pharmaceutical Scientists, the International Society for Pharmaceutical Engineering, and the Biomedical Engineering Society, Dr. Levin received the Ph.D. degree (1985) in biomathematics from the University of Washington, Seattle. 

Development of new process analytical tools - including sensors and data analysis -continues. Developments tend to grow out of necessity to solve a particular problem and arise from collaborative innovation between analytical chemists (in industry and academia) and industrial scientists and process engineers. Industrial scientists and engineers can... 

The formulation, manufacturing process, analytical development, and long-term toxicology studies in animals are parallel to the clinical investigation (Table 1.1). Clinical trial materials should be developed, manufactured, tested, and released before conducting a phase I clinical trial. Process chemists may redesign the synthetic route for the dmg candidate to meet the requirements of large-scale production in a pilot plant. Preformulation scientists complete the activities of salt selection,... 

The current regulatory climate of QbD places an emphasis on clinically relevant specifications and methods for in vitro dissolution.20 Development scientists should identify dissolution methodology that has been closely examined for its relevance to in vivo performance, as well as for mechanistic information. In other words, the release mechanism of the product should be understood and the dissolution test should be able to detect changes reflecting deviation of the mechanism. There is also the quality control (QC) side of dissolution testing, which, until the process analytical technology (PAT) develops beyond the current capabilities, is very important for stability and end-product release testing. 

Royal Pharmaceutical Society and American Association of Pharmaceutical Scientists (2003), The Key for Achieving New Standards of Manufacturing Excellence and Regulatory Compliance Process Analytical Technology, Eighth Arden House European Conference, March 24—26, London. 

The impact of early ADME and PK information in the drug discovery process has been significant. Studies that were difficult to envision 10 years ago are now compulsory. However, analytical scientists in the pharmaceutical industry are not able to rest on these accomplishments. Pharmaceutical companies are now faced with the potential loss in sales of 135 billion due to patent expirations between 2008 through 2012 [3], The pressure on discovery and development scientists has never been greater. These new challenges will likely create new opportunities. 

Ihe application of the concept of "detection limit" as a criterion by the analytical scientist for withholding the results of low-level measurement is not supported. This usage may arise from the mistaken belief that the one-tailed statistical t-test is a test of the quality of the result, rather than the extent to which the result indicates that analyte is present in the sample. It is also the result of confusing the limitations of detection and measurement with the limitations of the analytical process and the impact of sample matrix effects. A further argument against the use of this concept as the basis for not reporting results is the improper hypothesis that a low result Is necessarily derived from a population of results with mean zero. 

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