CZE is a well‐established technique for charge heterogeneity testing of biopharmaceuticals. It is based on the differences between the ratios of net charge and hydrodynamic radius. In an extensive intercompany study, it was recently shown that CZE is very robust and can be easily implemented in labs that did not perform it before. However, individual characteristics of some examined proteins resulted in suboptimal resolution. Therefore, enhanced method development principles were applied here to investigate possibilities for further method optimization. For this purpose, a high number of different method parameters was evaluated with the aim to improve CZE separation. For the relevant parameters, design of experiments (DoE) models were generated and optimized in several ways for different sets of responses like resolution, peak width and number of peaks. In spite of product specific DoE optimization it was found that the resulting combination of optimized parameters did result in significant improvement of separation for 13 out of 16 different antibodies and other molecule formats. These results clearly demonstrate generic applicability of the optimized CZE method. Adaptation to individual molecular properties may sometimes still be required in order to achieve optimal separation but the set screws discussed in this study [mainly pH, identity of the polymer additive (HPC versus HPMC) and the concentrations of additives like acetonitrile, butanolamine and TETA] are expected to significantly reduce the effort for specific optimization.
The aim of this study was to analyze the contents of Reg. (EU) No. 429/2016, and to assess its role in guaranteeing the efficient application of the disease prevention and control rules into member state. Furthermore, the authors evaluated the impact of the abovementioned Regulation on the legislation on public health and food safety already in force in Europe (Regulations EC No. 178/2002, No. 882/2004, No. 853/2004) and considered the global impact of the new rules on the effective functioning of the internal market. The study pays attention also to the TFEU (treaty of lisbon on the functioning of the European union) procedure to delegate to the commission the power to adopt non-legislative acts of general application that supplement or amend certain non-essential elements of a legislative act.
A Mexican painter and muralist of indigenous heritage, Rufino Tamayo was one of the most important representatives of figurative abstraction and poetic realism in 20th-century Latin American art. A supporter of the universalistic approach to art, in the late 1940s he started a controversy—the so called ‘‘polémica Tamayo’’—by positioning himself against the classical Mexican school and its ‘‘Big Three,’’ the muralists José Clemente Orozco, Diego Rivera and Alfaro Siqueiros. Contrary to the stress they put on art as political, Tamayo focused on its poetic and emotional aspects. Tamayo’s art is based both on Mexican figurative traditions (characterized by the rigor and geometry of pre-Hispanic sculpture and its imaginative and magical character), and on the influence of European and North American avant-garde movements, especially Impressionism, Fauvism, Cubism, Futurism, Surrealism and Abstract Expressionism. His sensibility for nature and spirituality, his interest in ordinary people, and his ability to synthesize different pictorial languages with Mexican folk art and beliefs, have made him a very popular artist, nationally and internationally. Throughout his career Tamayo directed his effort ‘‘towards the salvation of painting, the preservation of its purity and the perpetuation of its mission as translator of the world’’ (Paz 1985: 23).
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