Monoclonal antibodies (mAbs) are highly complex proteins that display a wide range of microheterogeneity that requires multiple analytical methods for full structure assessment and quality control. As a consequence, the characterization of mAbs on different levels is particularly product - and time - consuming. This work presents the characterization of trastuzumab sequence using sheathless capillary electrophoresis (referred as CESI) – tandem mass spectrometry (CESI-MS/MS). Using this bottom-up proteomic-like approach, CESI-MS/MS provided 100% sequence coverage for both heavy and light chain via peptide fragment fingerprinting (PFF) identification. The result was accomplished in a single shot, corresponding to the analysis of 100 fmoles of digest. The same analysis also enabled precise characterization of the post-translational hot spots of trastuzumab, used as a representative widely marketed therapeutic mAb, including the structural confirmation of the five major N-glycoforms.
BACKGROUND Many of the drugs being used in the treatment of the ongoing pandemic coronavirus disease 2019 (COVID-19) are associated with QT prolongation. Expert guidance supports electrocardiographic (ECG) monitoring to optimize patient safety.OBJECTIVE The purpose of this study was to establish an enhanced process for ECG monitoring of patients being treated for COVID-19.METHODS We created a Situation Background Assessment Recommendation tool identifying the indication for ECGs in patients with COVID-19 and tagged these ECGs to ensure prompt over reading and identification of those with QT prolongation (corrected QT interval . 470 ms for QRS duration 120 ms; corrected QT interval . 500 ms for QRS duration . 120 ms). This triggered a phone call from the electrophysiology service to the primary team to provide management guidance and a formal consultation if requested.RESULTS During a 2-week period, we reviewed 2006 ECGs, corresponding to 524 unique patients, of whom 103 (19.7%) met the Situation Background Assessment Recommendation tool-defined criteria for QT prolongation. Compared with those without QT prolongation, these patients were more often in the intensive care unit (60 [58.3%] vs 149 [35.4%]) and more likely to be intubated (32 [31.1%] vs 76 [18.1%]). Fifty patients with QT prolongation (48.5%) had electrolyte abnormalities, 98 (95.1%) were on COVID-19-related QT-prolonging medications, and 62 (60.2%) were on 1-4 additional non-COVID-19-related QT-prolonging drugs. Electrophysiology recommendations were given to limit modifiable risk factors. No patient developed torsades de pointes.CONCLUSION This process functioned efficiently, identified a high percentage of patients with QT prolongation, and led to relevant interventions. Arrhythmias were rare. No patient developed torsades de pointes.
Background During the COVID-19 pandemic, attempts to conserve resources and limit virus spread have resulted in delay of nonemergent procedures across all medical specialties including cardiac electrophysiology. Many patients have delayed care and continue to express concerns about potential nosocomial spread of coronavirus. Objective To quantify risk of development of COVID19 due to in-hospital transmission related to an electrophysiology procedure, in the setting of preventive measures instituted in our laboratory areas. Methods We contacted patients by telephone who underwent emergent procedures in the electrophysiology lab during the COVID19 surge at our hospital (3/16/2020 to 5/15/2020, reaching daily census 450 COVID19 patients,) > two weeks after the procedure, to assess for symptoms of and/or testing for COVID-19, and assessed outcomes from medical record review. Results Of the 124 patients undergoing EP procedures in this period, none had developed documented or suspected coronavirus infection. 7 patients described symptoms of chest pain, dyspnea, or fever; 3 were tested for coronavirus and found to be negative. Of the remaining 4, 2 had a more plausible alternative explanation for the symptoms, and 2 had transient symptoms not meeting published criteria for probable COVID19 infection. Conclusion Despite a high hospital census of COVID-19 patients during the period of hospital stay for an electrophysiology procedure, there were no likely COVID-19 infections occurring in follow up of at least two weeks. With proper use of preventive measures as recommended by published guidelines, the risk of nosocomial spread of COVID-19 to patients in the electrophysiology lab is low.
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