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A potent single digit picomolar fully human monoclonal antibody (hMAb) inhibitor with a high degree of specificity to the antigen of interest was identified from a phage display library. The hMAb, however, exhibited a high degree of hydrophobicity and easily formed insoluble aggregates when purified using a Protein A based generic process. Strategies were designed using both protein engineering and process development approaches to optimize the molecule's amino acid sequence and its behavior in process conditions. The insoluble aggregation issue was brought under control by one single amino acid mutation in CDR region or by switching to non-ProA based purification process. Our study therefore presents the rational manufacturability design for future monoclonal antibody product and its purification process under the quality by design concept by either engineering the drug molecule to adapt existing platform process or optimizing the process to fit the specific properties of the drug product.

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We developed a novel variation on classroom data collection by having students conduct a national research project. Students at 20 different colleges and universities measured "school spirit" at their institutions according to several operational criteria (school apparel wearing, car stickers, alumni donation rate, ratings by a major sports publication, and questionnaire measures). Instructors then combined this information into one large dataset, allowing students to analyze and compare trends measured at their school with those measured at other schools. We discuss the process of organizing a national study (recruitment of faculty participants, dissemination of instruments, compilation of data), aspects of the project that instructors thought were most educationally valuable, and substantive results of the study (how well the different measures of school spirit correlated).

The cannabis industry is a complex set of industries involving consumer, medical, and industrial products and services. NAICS classification and government data usually provide limited value to North American researchers supporting cannabis entrepreneurship, particularly since the United States federal government (unlike that of Canada) does not yet recognize the legalization of cannabis. Social equity continues to be one motivation for cannabis entrepreneurship, given this historic targeting of U.S. and Canadian people of color for cannabis-related criminal offenses. Nonprofits and provincial, state, and local governments are now providing support for people of color working in this industry. In addition to government data, proprietary databases, trade associations, consulting firms, and boutique data and analytics firms provide data and analysis to research the cannabis industry and support its entrepreneurs.