Pharmaceutical Technology - November 2018

Pharmaceutical Technology - eBook

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12 Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 P h a r mTe c h . c o m Measurement Science change was likely precipitated by the increasing complexity of new pharmaceuticals, most nota- bly, the hepatitis C protease inhibitors. The rise of C-H [carbon-hydrogen] activation strategies in small-molecule chemical synthesis has led to an increasing need for discriminating between very closely related chemical species. This requirement for improved resolution is being addressed through the introduction of new chromatographic station- ary phases with unique selectivity and through general improvements that increase the efficiency of chromatographic columns and instrumentation. Similarly, an increasing focus on resolving closely related species in biological drugs is leading to a f lurry of important advances. PharmTech: What do you see as the most pressing unmet needs in pharmaceutical analysis? Welch: When I talk with experts in the field about this topic, I hear a variety of opinions, but I also hear some common themes. Researchers are look- ing for improved approaches for carrying out on- line reaction analysis and kinetic profiling. They are looking for faster, simpler, and cheaper analyti- cal instrumentation and portable equipment that can allow testing to move out of the traditional analytical laboratory. They are looking for im- proved imaging technologies (including chemical imaging), and finally, there is growing interest in intelligent analytical instrumentation where the use of artificial intelligence speeds, streamlines, and simplifies the task of carrying out analytical investigations. Industry–academia collaboration PharmTech: What do you see as the role and the ad- vantage of precompetitive research, such as that performed in NSF Industry–University Coopera- tive Research Centers (IUCRCs)? Welch: The stance of US industry toward pre- competitive collaboration has changed dramati- cally over the past few years. When I began my industrial career, large companies did everything, with glass blowers, machine shops, and specialist researchers dedicated to staying abreast of emerg- ing capabilities and working to create next-gen- eration research tools and techniques. With the breathtaking pace of scientific innovation today, it is becoming increasingly difficult—and expen- sive—for companies to remain at the cutting edge. Pricing pressures over the past few years have led to significant restructuring within industry in an attempt to lower costs and improve research productivity. At the same time, there has been a growing realization that much of the effort aimed at creating next-generation research capabilities is essentially precompetitive in nature, and that sig- nificant savings and improved outcomes can often be gained when competing companies from across an entire industry sector band together to cooper- ate and share costs. The NSF IUCRC program has been around for more than 25 years and is a shin- ing example of how industries and academia can work together in a precompetitive fashion to focus academic creativity on addressing major unmet challenges of industrial importance. PharmTech: How does this differ from traditional modes of industry–academia collaboration? Welch: I worked for many years in the pharma- ceutical industry and have been involved in doz- ens of traditional research collaborations with academia, where a single company contracts with a single university to carry out research of mutual

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