A5084431599- Biosimilars and Bioanalytical Methods
- Advanced Biosensing Techniques and Applications
- Monoclonal and Polyclonal Antibodies Research
- Protein purification and stability
- Computational Drug Discovery Methods
- Clinical Laboratory Practices and Quality Control
- Statistical Methods in Clinical Trials
- Cell Image Analysis Techniques
- Biosensors and Analytical Detection
- Microfluidic and Capillary Electrophoresis Applications
- HER2/EGFR in Cancer Research
- Biotin and Related Studies
- Pesticide Residue Analysis and Safety
- Advanced biosensing and bioanalysis techniques
- Cholinesterase and Neurodegenerative Diseases
- Blood groups and transfusion
- Glycosylation and Glycoproteins Research
- Viral Infectious Diseases and Gene Expression in Insects
- 3D Printing in Biomedical Research
- Cancer Immunotherapy and Biomarkers
- Signaling Pathways in Disease
- Innovative Microfluidic and Catalytic Techniques Innovation
- SARS-CoV-2 and COVID-19 Research
- Chemical Synthesis and Analysis
- T-cell and B-cell Immunology
Bristol-Myers Squibb (United States)
2011-2022
Bioanalytical Systems (United States)
2013-2018
Bristol-Myers Squibb (Germany)
2012-2015
Amgen (United States)
2003-2011
Procter & Gamble (United States)
2000-2001
University of Kansas
1995-2000
Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues Bioanalysis (WRIB). Like previous sessions, this event was format of a practical, focused, highly interactive informative workshop aiming for high-quality, improved compliance scientific excellence. Numerous 'hot' topics bioanalysis both small large molecules were shared discussed, leading to consensus recommendations among panelists attendees...
The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs regulatory agencies to discuss, review, share perspectives, provide potential solutions agree upon consistent approach recent issues bioanalysis of both small large molecules. High quality, better compliance regulations scientific excellence are foundation this workshop. As previous editions significant event,...
An LC-MS/MS assay was developed and fully validated for the simultaneous quantitation of two coadministered human monoclonal antibodies (mAbs), mAb-A mAb-B IgG4 subclass, in monkey serum. The total serum proteins were digested with trypsin at 50 °C 30 min after methanol denaturation precipitation, dithiothreitol reduction, iodoacetamide alkylation. tryptic peptides chromatographically separated a C18 column (2.1 × 100 mm, 1.7 μm) mobile phases 0.1% formic acid water acetonitrile. Four...
The 2013 7th Workshop on Recent Issues in Bioanalysis was held Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs regulatory agencies convened discuss current topics of interest bioanalysis. These 'hot' topics, which covered both small large molecules, were the starting point for fruitful exchanges knowledge, sharing ideas among speakers, panelists attendees. discussions led specific recommendations pertinent bioanalytical...
The 2017 11th Workshop on Recent Issues in Bioanalysis took place Los Angeles/Universal City, California, 3-7 April with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event - full immersion week bioanalysis, biomarkers immunogenicity. As usual, it specifically designed facilitate sharing, reviewing, discussing agreeing...
The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion the evolving field of bioanalysis, took place Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations regulatory agencies worldwide convened share, review, discuss agree approaches address current issues interest bioanalysis. topics covered included both small large molecules, involved LCMS, hybrid LBA/LCMS, LBA...
Immunogenicity testing for antidrug antibodies (ADA) faces challenges when high levels of the drug are present in clinical patient samples. In addition, most functional cell-based assays designed to characterize neutralizing ability ADA vulnerable interference from endogenous serum components. Bead extraction and acid dissociation (BEAD) has been successfully applied extract samples prior conduction assays. However, BEAD, certain amounts components (so-called residual components) carried...
Antibody-drug conjugates (ADCs) are complex drug constructs with multiple species in the heterogeneous mixture that contribute to their efficacy and toxicity. The bioanalysis of ADCs involves assays analytical platforms.A series ligand binding LC-MS/MS (LB-LC-MS/MS) hybrid assays, through different combinations anti-idiotype (anti-Id), anti-payload, or generic capture reagents, cathepsin-B trypsin enzyme digestion, were developed evaluated for analysis conjugated-payload as well...
The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion the evolving field of bioanalysis, took place Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations regulatory agencies worldwide convened share, review, discuss agree approaches address current issues interest bioanalysis. topics covered included both small large molecules, involved LCMS, hybrid LBA/LCMS, LBA...
Background: The bioanalytical strategy for antibody–drug conjugates (ADC) includes numerous measurements integrally designed to provide comprehensive characterization of PK, PD and immunogenicity. This manuscript describes the utilization reagents specifically tailored an ADC with a microtubule polymerization inhibitor payload cathepsin B cleavable linker. Methods: PK evaluation physiological levels total antibody, active ADC, antibody-conjugated unconjugated payload. These data are...
Extensive use of polyethylene glycol (PEG) in consumer products necessitates the assessment anti-PEG antibodies (APAb).In clinical trials comparing PEG-IFN-λ to PEG-IFN-α, conventional bridge and direct assays were assessed.The assay detected IgM IgG APAb reactive with common PEG sizes derivatives at sufficient sensitivity, 15-500 ng/ml. Of subjects evaluated, 6% 9% PEG-IFN-α had persistent while 60% 33% anti-interferon (AIAb). Pre-existing AIAb prevalence was comparable (approximately 10%...
The 2011 annual conference of the American Association Pharmaceutical Scientists, held in Washington DC, USA, hosted a roundtable entitled: 'Update US FDA/European Medicines Agency (EMA) harmonization their bioanalytical guidance - Global Bioanalytical Consortium activity and impact on small large molecules.' was initiated with presentation from CT Viswanathan history revision FDA guideline method validation. It followed by Jan Welink who presented an update final European validation...