A5003911513- Biosimilars and Bioanalytical Methods
- Monoclonal and Polyclonal Antibodies Research
- Breast Cancer Treatment Studies
- Protein Kinase Regulation and GTPase Signaling
- Neuroendocrine Tumor Research Advances
- Endometrial and Cervical Cancer Treatments
- Ovarian cancer diagnosis and treatment
- Growth Hormone and Insulin-like Growth Factors
- Protein purification and stability
- Pituitary Gland Disorders and Treatments
- Cancer Cells and Metastasis
- Estrogen and related hormone effects
- Cancer, Hypoxia, and Metabolism
- CAR-T cell therapy research
- Angiogenesis and VEGF in Cancer
- Breast Lesions and Carcinomas
- Advanced Biosensing Techniques and Applications
- Endometriosis Research and Treatment
- Cellular transport and secretion
- Cancer and Skin Lesions
- Carbohydrate Chemistry and Synthesis
- Cell Adhesion Molecules Research
- Liver Disease Diagnosis and Treatment
- Pneumonia and Respiratory Infections
- SARS-CoV-2 detection and testing
AstraZeneca (United States)
2019-2025
GTx (United States)
2020
AstraZeneca (Switzerland)
2020
Medical University of Lodz
2005-2015
Boehringer Ingelheim (Germany)
2011
Florida Center for Gastroenterology
2010
Copernicus Memorial Hospital
2006-2007
University of Illinois Chicago
1995-2007
Scripps Research Institute
2001-2002
The Ohio State University
1998-2001
The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place New Orleans, LA, USA April 1–5, with an attendance of over 1000 representatives 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 gene therapy. As usual, it specifically designed to facilitate sharing, reviewing, discussing agreeing...
The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually June 15-29, 2020 with an attendance over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology contract research organizations, and regulatory agencies worldwide. WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days order to allow exhaustive thorough coverage all major issues bioanalysis, biomarkers, immunogenicity, gene...
Nirsevimab is approved in the US for prevention of respiratory syncytial virus (RSV) lower tract disease neonates and infants during their first RSV season children aged ≤24 months who remain vulnerable to severe through second season. We summarize a pre-specified analysis nirsevimab safety data from three randomized controlled trials: Phase 2b (NCT02878330; healthy born ≥29 <35 weeks' gestational age [wGA]); 3 MELODY (NCT03979313; ≥35 wGA); 2/3 MEDLEY (NCT03959488; with congenital heart...
The 17th Workshop on Recent Issues in Bioanalysis (17th WRIB) took place Orlando, FL, USA June 19–23, 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest bioanalysis. WRIB included 3 Main Workshops 7 Specialized that together spanned 1 week allow an exhaustive thorough coverage all major issues bioanalysis biomarkers, immunogenicity, gene therapy, cell therapy vaccines....
The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held 27 September to 1 October 2021. Even with a last-minute move from in-person virtual, an overwhelmingly high number nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), multiple regulatory agencies still eagerly convened actively discuss most current topics interest bioanalysis. WRIB included 3 Main Workshops 7 Specialized that together spanned week...
Abstract Background AZD7442 is a combination of extended half-life, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)−specific neutralizing monoclonal antibodies (tixagevimab and cilgavimab). Methods This phase 1, first-in-human, randomized, double-blind, placebo-controlled, dose-escalation study evaluated administered intramuscularly (300 mg) or intravenously (300, 1000, 3000 in healthy adults (aged 18–55 years). The primary end point was safety tolerability. Secondary points...
In children with congenital heart disease and/or chronic lung entering their second respiratory syncytial virus (RSV) season, 200 mg nirsevimab had a similar safety profile to that of palivizumab and resulted in serum exposures associated efficacy healthy infants, supporting this population at risk severe RSV disease.
The 18th Workshop on Recent Issues in Bioanalysis (18th WRIB) took place San Antonio, TX, USA May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest bioanalysis. WRIB included 3 Main Workshops 7 Specialized that together spanned 1 week allow an exhaustive thorough coverage all major issues bioanalysis biomarkers, immunogenicity, gene therapy, cell therapy...
Triple negative breast cancer (TNBC) has caught the attention of oncologists worldwide because poor prognosis and paucity targeted therapies. Gene pathways have been widely studied, but less is known about epigenetic factors such as microRNAs (miRNAs) their role in tailoring an individual systemic surgical approach for patients. The aim study was to examine selected miRNAs TNBC core biopsies sampled before preoperative chemotherapy subsequent pathologic response mastectomy or conservation...
Studies of cellular signal transduction mechanisms involving receptor-mediated generation inositol phosphates and phosphorylated phosphatidylinositols require easy access to these naturally occurring products. Although numerous synthetic methods have been developed during the past decade, most suffer from excessive length lack generality. In this work we describe comprehensive uniform synthesis all such as phosphatidylinositol, phosphatidylinositol 3-phosphate, 4-phosphate, 5-phosphate,...
Human endocrine tumors often express the somatostatin receptors SSTR 1–5 with different intensity. It has been widely investigated their distribution in pituitary adenomas, brain tumors, adrenal and neuroendocrine gastrointestinal tract (NET). Some of studies also concern expression SSTRs thyroid but they are mainly limited to parafollicular C cells – derived medullary carcinomas (MTC). Results detection other pathologies like follicular adenomas papillary cancers still scarce controversial,...
Abstract During biotherapeutic drug development, immunogenicity is evaluated by measuring anti-drug antibodies (ADAs). The presence and magnitude of ADA responses assessed using a multi-tier workflow where samples are screened, confirmed, titered. Recent reports suggest that the assay signal to noise ratio ( S / N ) obtained during screening tier correlates well with titer. To determine whether could more broadly replace titer, anonymized data from consortium sponsors was collected analyzed....
The 2022 16th Workshop on Recent Issues in Bioanalysis (WRIB) took place Atlanta, GA, USA September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest bioanalysis. WRIB included 3 Main Workshops 7 Specialized that together spanned 1 week order allow exhaustive thorough coverage all major issues bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy...
Deamidation, a common post-translational modification, may impact multiple physiochemical properties of therapeutic protein. MEDI7247, pyrrolobenzodiazepine (PBD) antibody-drug conjugate (ADC), contains unique deamidation site, N102, located within the complementarity-determining region (CDR), impacting affinity MEDI7247 to its target. Therefore, it was necessary monitor status in vivo. Due low dose, sensitive absolute quantification method using immunocapture coupled with liquid...
Oncologists now favor more personalized treatment strategies in breast cancer patients. Gene expression analysis has been widely used, but less is known about epigenetic factors, for example, microRNAs (miRNAs). The aim of this study was to determine the relationship between selected miRNAs and receptor status core biopsies sampled before preoperative chemotherapy stage III locally advanced (LABC) In 37 LABC biopsies, three per sample were analyzed: hsa-miR-93-5p, hsa-miR-190a,...
AZD7442 (tixagevimab [AZD8895]/cilgavimab [AZD1061]) is a monoclonal antibody (mAb) combination in development for the prevention and treatment of coronavirus disease 2019. Traditionally, bioanalysis mAbs performed using ligand binding assays (LBAs), which offer sensitivity, robustness, ease implementation. However, LBAs frequently require generation critical reagents that typically take several months. Instead, we developed highly sensitive (5 ng/mL limit quantification) method hybrid...