2021
DOI: 10.1208/s12248-021-00671-0
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Assessment of Functional Characterization and Comparability of Biotherapeutics: a Review

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Cited by 9 publications
(16 citation statements)
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“…MALDI matrix clusters interfering with the identified markers that are within the mass resolution of the MS instrument, ion mobility spectrometry was performed. Our experimentally deduced collisional cross section (CCS) values of 198 ± 2 Å 2 (ATP), and GSH, 163 ± 2 Å 2 (GSH) are comparable with CCS values predicted by machine learning approaches 27,28 and that are listed in the Human Metabolome Database (HMDB; http://www.hmdb.ca) [196.8 Å 2 for ATP (HMDB0000538) and 161.9 Å 2 for GSH (HMDB0000125)( Fig. 2c and S3b ).…”
Section: Resultsmentioning
confidence: 89%
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“…MALDI matrix clusters interfering with the identified markers that are within the mass resolution of the MS instrument, ion mobility spectrometry was performed. Our experimentally deduced collisional cross section (CCS) values of 198 ± 2 Å 2 (ATP), and GSH, 163 ± 2 Å 2 (GSH) are comparable with CCS values predicted by machine learning approaches 27,28 and that are listed in the Human Metabolome Database (HMDB; http://www.hmdb.ca) [196.8 Å 2 for ATP (HMDB0000538) and 161.9 Å 2 for GSH (HMDB0000125)( Fig. 2c and S3b ).…”
Section: Resultsmentioning
confidence: 89%
“…Glutathione ([M-H] - ; m/z 306.0765) was selected as target compound in negative ion mode in the m/z range 200-1300 Da for both timsOFF/QTOF mode and timsON measurements. The settings for timsON were: 1/K0 Start: 0.50 V·s/cm 2 , 1/K 0 End: 1.00 V·s/cm 2 , Ramp time 60.0 ms. Accumulation time was 14.8 ms, duty cycle 24.67% and the Ramp time 15.36 Hz. Laser application imaging 100 µm with 148 shots at 10,000 Hz with 10 shots per raster position and random walk enabled over the complete sample with a spot diameter of 2000 µm were used.…”
Section: Methodsmentioning
confidence: 99%
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“…Therefore a systematic approach is required, where the Critical Quality Attributes (CQAs) which are likely to impact the performance of a particular class of product can be linked to the possible CPPs and RMAs that are most likely to have an impact on those CQAs. Typical CQAs for a biotherapeutic might include, but are not limited to [33,34].…”
Section: Importance Of Titre and Robustnessmentioning
confidence: 99%
“…Разработка биоаналогичных препаратов МкАТ представляет собой сложный многоступенчатый процесс, на этапах которого должны быть определены и подробно изучены критические параметры качества МкАТ, включая первичную и пространственную структуры, посттрансляционные модификации, изоформы продукта, биологические функции на молекулярном и клеточном уровнях, что необходимо для оценки свойств препаратов при коммерческом производстве [7]. Влияние параметров качества на безопасность и эффективность препарата основано на структурно-функциональной взаимосвязи [8].…”
Section: Introductionunclassified