bioanalysisjournal.com

Bart Corsaro‡, Tong-yuan Yang‡, Rocio Murphy‡, Ivo Sonderegger‡, Andrew Exley‡§, Sylvie Bertholet‡, Naveen Dakappagari‡, Francis Dessy‡, Fabio Garofolo‡§ Abstract The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. The 14th WRIB included three Main Workshops, seven […]

Nico C van de Merbel Abstract Over the past 10 years, there has been a remarkable increase in the use of LC–MS for the quantitative determination of proteins, and this technique can now be considered an established bioanalytical platform for the quantification of macromolecular drugs and biomarkers, next to the traditional ligand-binding assays. Many researchers

Mark Wissel, Martin Poirier, Christina Satterwhite, John Lin, Rafiq Islam, Jennifer Zimmer, Ardeshir Khadang, Jennifer Zemo, Todd Lester, Marianne Fjording, Amanda Hays…. Abstract Gene therapy, cell therapy and vaccine research have led to an increased use of qPCR/ddPCR in bioanalytical laboratories. CROs are progressively undertaking the development and validation of qPCR and ddPCR assays. Currently, however, there is limited regulatory guidance for the use of

Wanlong Zhou, Shuang Yang& Perry G Wang Although, LC–MS is one of the most sensitive and selective analytical techniques, it often suffers from matrix effects, especially when using ESI for analyzing extracts of complicated matrices [1–3]. Matrix effects are often caused by the alteration of ionization efficiency of target analytes in the presence of co-eluting compounds in the

Yan Mao & Kelly Coble Abstract Keywords: bispecific biotherapeutics,clinical antidrug antibody characterization,multidomain biotherapeutics,pre-existing antidrug antibody,treatment-emergent antidrug antibody Antibody engineering has dramatically evolved in recent years, resulting in current conventional antibody therapeutics having fewer immune-related adverse effects observed in the clinic. However, the advanced antibody engineering technologies have also created a great variety of novel antibody-based therapeutics with

Xiao Zhang‡, Chunjie Sha‡, Wei Zhang, Fengjuan Zhao, Mingli Zhu, Guangyi Leng& Wanhui Liu Abstract Background: The fully phosphorothioate-modified oligonucleotide (OGN) nusinersen has low ionization efficiency in the negative ion mode, resulting in a low mass spectrometry response. There have been no relevant reports on developing a LC–MS method for the determination of nusinersen by optimizing mobile phase composition. Materials & methods: Mobile phase additives comprised of 15 mM triethylamine/25 mM

Ruiqi Liu‡, Xiaojie Li‡, Yingyi Liu, Lijun Du, Yingzhu Zhu, Lichuan Wu  & Bo Hu Abstract Background: Blood-invasive fungal infections can cause the death of patients, while diagnosis of fungal infections is challenging. Methods: A high-speed microscopy detection system was constructed that included a microfluidic system, a microscope connected to a high-speed camera and a deep learning analysis section. Results: For training data, the sensitivity and specificity

Rodd Polsky , George Gunn, Kimberly J Reese, Charles Scott Hottenstein, Andrew Gehman, Ann Schwartz, Devin Root & Amy Concannon Abstract The measurement of antidrug antibodies (ADA) in nonclinical studies provides limited value because the formation and incidence of nonclinical ADA does not translate to clinical experience. The formation and presence of ADA in nonclinical species can, however, correlate to reduced drug exposure and safety

Abstract Aims: To develop and validate a UHPLC-MS/MS method for lamotrigine (LTG) analysis in human plasma and evaluate its agreement with a homogenous enzyme immunoassay (HEIA). Materials & methods: The UHPLC-MS/MS method was developed and validated according to the USFDA/EMA guidelines. A Bland–Altman plot was used to evaluate the agreement between UHPLC-MS/MS and HEIA. Results: Samples were pretreated with one-step protein precipitation and separated in

Abstract Validation of biomarker assays is crucial for effective drug development and clinical applications. Interlaboratory reproducibility is vital for reliable comparison and combination of data from different centers. This review summarizes interlaboratory studies of quantitative LC–MS-based biomarker assays using reference standards for calibration curves. The following points are discussed: trends in reports, reference and internal