A5036832640- Biosimilars and Bioanalytical Methods
- Advanced Biosensing Techniques and Applications
- Monoclonal and Polyclonal Antibodies Research
- Biosensors and Analytical Detection
- Advanced biosensing and bioanalysis techniques
- Protein purification and stability
- Chronic Myeloid Leukemia Treatments
- Reproductive tract infections research
- Multiple Myeloma Research and Treatments
- Drug Transport and Resistance Mechanisms
- Virus-based gene therapy research
- Chronic Lymphocytic Leukemia Research
- Gene expression and cancer classification
- Cervical Cancer and HPV Research
- Microfluidic and Bio-sensing Technologies
- HER2/EGFR in Cancer Research
- Statistical Methods in Clinical Trials
- Cell Image Analysis Techniques
- Advanced Proteomics Techniques and Applications
- Near-Field Optical Microscopy
- Fibroblast Growth Factor Research
- Bariatric Surgery and Outcomes
- Chemotherapy-induced cardiotoxicity and mitigation
- Neuroendocrine Tumor Research Advances
- Chemotherapy-induced organ toxicity mitigation
Universidade de Caxias do Sul
2024
Advanced Pharma
2020-2023
Sun Pharma (United States)
2023
GlaxoSmithKline (United States)
2019
Bristol-Myers Squibb (United States)
2013-2018
Bioanalytical Systems (United States)
2013-2018
Bristol-Myers Squibb (Germany)
2015-2016
Johnson & Johnson (United States)
2011-2012
Novartis (Switzerland)
1993
Saint Louis University
1982-1984
Two observational studies were conducted to support an initiative qualify translational kidney safety biomarkers as clinical drug development tools that identify tubular injury prior changes in estimated glomerular filtration rate (eGFR). Normal healthy volunteers provided three morning spot urine collections over 4 weeks. Patients undergoing surgical resection and intrathoracic cisplatin for malignant pleural mesothelioma samples pre- postoperatively at 4, 8, 12 hours daily 6 days. Using...
The complete amino acid sequence of the Escherichia coli alkaline phosphatase subunit [orthophosphoric-monoester phosphohydrolase (alkaline optimum), EC 3.1.3.1, isozyme 3] has been determined. monomer contains 449 residues in a single unglycosylated polypeptide chain having calculated Mr 47,029. Isozyme 1 an additional arginine residue at NH2 terminus that presumably results from variability processing precursor molecules. Sequence data were obtained both manual and automatic Edman...
Roux-en-Y gastric bypass (RYGB) has been shown to induce rapid and durable reversal of type 2 diabetes.The aim the study was investigate a possible mechanism for remission diabetes after RYGB.A cross-sectional, nonrandomized, controlled conducted. Surgery patients were studied before RYGB 1 wk 3 months surgery.This conducted at East Carolina University.Subjects recruited into three groups: 1) lean controls with no surgery [body mass index (BMI) < 25 kg/m²; n = 9], 2) severely obese diabetic...
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 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 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology contract research organizations, and regulatory agencies worldwide. WRIB was once again a weeklong event - A Full Immersion Week for PK, Biomarkers Immunogenicity. As usual, it is specifically designed facilitate sharing, reviewing, discussing agreeing approaches address the most current...
BackgroundPreclinical evidence suggests that c-Abl is critical in the pathogenesis of Parkinson's Disease (PD). Vodobatinib (K0706) a potent, specific Abl kinase inhibitor currently being developed for treatment PD. In previously reported studies, nilotinib, multikinase inhibitor, did not show clinical activity as evidenced by no improvement symptoms or rate decline after one to six months at maximum permissible dose, presumably because insufficient CNS penetration. Here we report PK and...
The 2018 12th Workshop on Recent Issues in Bioanalysis (12th WRIB) took place Philadelphia, PA, USA April 9-13, with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day full immersion bioanalysis, biomarkers immunogenicity. As usual, it specifically designed to facilitate sharing, reviewing, discussing agreeing approaches address the most current...
Protein microarray-based approaches are increasingly being used in research and clinical applications to either profile the expression of proteins or screen molecular interactions. The development high-throughput, sensitive, convenient, cost-effective formats for detecting is a necessity effective advancement understanding disease processes. In this paper, we describe generation highly multiplexed, antibody-based, specific, sensitive protein microarrays coupled with rolling-circle signal...
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%...
Understanding the properties of protein-based therapeutics is a common goal biologists and physicians. Technical barriers in direct observation small proteins or therapeutic agents can limit our knowledge how they function solution body. Electron microscopy (EM) imaging performed liquid environment permits us to peer into active world cells molecules at nanoscale. Here, we employ cell EM directly visualize its native conformation aggregate state time-resolved manner. In combination with...
Addressing safety concerns such as drug-induced kidney injury (DIKI) early in the drug pharmaceutical development process ensures both patient and efficient clinical development. We describe a unique adjunct to standard assessment wherein metabolite profile of treated animals is compared with MetaMap Tox metabolomics database order predict potential for wide variety adverse events, including DIKI. To examine this approach, study five compounds (phenytoin, cyclosporin A, doxorubicin,...
We have tested three parameters in sperm-mediated gene transfer assays with mice and pigs: (i) the epididymal versus ejaculated origin of sperm cells, (ii) primary structure, (iii) amount challenging foreign DNA. found that pVLCNhGH construct, retrotransposon origin, causes a massive embryo lethality yet increases yield genetic transformation among born animals both species compared to viral constructs. Arrest embryonic development is DNA dose-dependent effect, which observed high doses,...
Ligand-binding assay (LBA) performance depends on quality reagents. Strategic reagent screening and characterization is critical to LBA development, optimization validation. Application of advanced technologies expedites the development process. By evaluating surface plasmon resonance technology that offers high-throughput kinetic information, this article aims provide perspectives applying strategic supported by a number case studies from multiple biotherapeutic programs.
Polyethylene glycol (PEG) is a polymer that can be conjugated with therapeutic proteins. Monitoring anti-PEG antibodies in human subjects may required as part of immunogenicity assessment. The lack well-characterized reagents have limited our understanding humoral response.Antibodies reactive to PEG were engineered IgG1 Fc. Surface plasmon resonance and plate-based methods demonstrated their binding was dependent on molecular weight (MW) PEG. Specificity experiments using chemical analogs...
Abstract Arginine methylation has been recognized as a post-translational modification with pleiotropic effects that span from regulation of transcription to metabolic processes contribute aberrant cell proliferation and tumorigenesis. This brought significant attention the development therapeutic strategies aimed at blocking activity protein arginine methyltransferases (PRMTs), which catalyze formation various methylated products on wide variety cellular substrates. GSK3368715 is small...
Ligand-binding assay (LBA) reagent labeling may change the binding characteristics of to its target and degrade performance in LBAs.A surface plasmon resonance (SPR) biosensor was used evaluate impact biotin process on reagent-binding kinetics affinity for a specific target. The SPR results demonstrate that molar challenge ratio affects both association dissociation rates labeled also predict LBAs.The methodology this study provides an example using as efficient way analytically functionally...