AI Magazine Issue 2 2018- Global Care Clinical Trials

Acquisition International - Issue 2 2018 13 of its ultra-high resolution µ PAC TM HPLC columns and high accuracy mass spectrometers (LC-MS) were used to reveal details of a.o. trastuzumab (Herceptin) originator and similars, or its conjugate ado-trastuzumab emtansine (Kadcyla). In mAb or ADC mapping analyses, small differences in the sequence reflecting point mutations, the position and prevalence of post-translational modifications, glycosylations, or deamidations that can arise during production or storage of the compounds, can have major impact on biological performance and regulatory approval. PharmaFluidics’ Micro-Chip chromatography µ PAC TM is the first micro-Chip chromatography device that is manufactured using lithographic micromachining techniques. The lay-out of the stationary phase support structure is carefully designed. The perfectly ordered backbone of the separation bed is formed by etching interstitial volumes out of a silicon wafer. The low ‘on-column’ dispersion, obtained thanks to the perfect order, virtually eliminates axial peak dispersion, resulting in higher column plate numbers with sharper peaks and higher concentration of compounds. The freestanding nature of the pillars also leads to much lower backpressure allowing the use of very long columns. These exceptional properties result in excellent chromatographic performance with high-resolution and high sensitivity. This new approach significantly improves LC analysis in complex mixtures of biological samples. Lastly, PharmaFluidics’ columns are compatible with all commercial nano-LC equipment. A Game Changer in Technology