Pharmaceutical Technology - November 2018

Pharmaceutical Technology - eBook

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10 Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 P h a r mTe c h . c o m GORODENKOFF/STOCK.ADOBE.COM Measurement Science P recompetitive research is increasingly being considered as a cost-effective way to find solutions to widespread problems in the bio/pharmaceutical industry and advance innova- tions for the benefit of patients. Christopher Welch, PhD, is principal with consulting firm Welch Innovation and serves as the director of the Indiana Consortium for Analytical Sciences and Engineering, a joint venture between Purdue University, the Uni- versity of Notre Dame, and Indiana University. Welch spoke with Pharmaceutical Technology about trends in pharmaceutical analy- sis, the advantages of precompetitive research, and the consortium's planning of a proposed Center for Bioanalytic Metrology, sponsored by the National Science Foundation (NSF). Trends PharmTech: What have been the most significant developments for pharmaceutical analysis in recent years? Welch: I see a lot of different threads coming together, making this a very exciting time for the field of pharmaceutical analysis. Over the past few years, the requirement to quantify potential mutagenic impurities at very low levels has created a real need to increase the sensitivity of analytical methods, leading to a focus on maximizing signal, minimizing noise, and the widespread adoption of mass spec- trometry detection in chromatographic QA/QC [quality assurance/ quality control] testing. Supercritical f luid chromatography (SFC) has long been the preferred analytical technique for stereochemi- cal analysis in non-GMP pharmaceutical research, but in the past few years it has finally broken through to become a staple in GMP analytical testing to support pharmaceutical manufacturing. This Precompetitive Research Spurs Innovation in Pharmaceutical Analysis Industry–academia collaborations, such as the Indiana Consortium for Analytical Sciences and Engineering's proposed Center for Bioanalytic Metrology, seek to address unmet needs in measurement science. Jennifer Markarian is manufacturing editor at Pharmaceutical Technology. Jennifer Markarian

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