A5102807425- Biosimilars and Bioanalytical Methods
- Monoclonal and Polyclonal Antibodies Research
- Protein purification and stability
- CAR-T cell therapy research
- Advanced Biosensing Techniques and Applications
- Biosensors and Analytical Detection
- SARS-CoV-2 and COVID-19 Research
- Celiac Disease Research and Management
- Cell Image Analysis Techniques
- Wheat and Barley Genetics and Pathology
- SARS-CoV-2 detection and testing
- Food composition and properties
- Eosinophilic Esophagitis
- Mycotoxins in Agriculture and Food
- Allergic Rhinitis and Sensitization
- Electrochemical Analysis and Applications
- CRISPR and Genetic Engineering
- Viral Infections and Outbreaks Research
- NF-κB Signaling Pathways
- Transgenic Plants and Applications
- Food Allergy and Anaphylaxis Research
- Innovative Microfluidic and Catalytic Techniques Innovation
- Mechanics and Biomechanics Studies
- Electrochemical sensors and biosensors
- Viral Infectious Diseases and Gene Expression in Insects
Regeneron (United States)
2016-2025
Sandia National Laboratories California
2016
Indiana University South Bend
2014
Bury College
2013
Columbia University
2001-2010
Rutgers, The State University of New Jersey
2003
Plant Industry
2001
Commonwealth Scientific and Industrial Research Organisation
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...
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 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 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...
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 three Main Workshops seven Specialized that together spanned...
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...
REGEN-COV is a cocktail of two human IgG1 monoclonal antibodies (REGN10933 + REGN10987) that targets severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein and has shown great promise to reduce the SARS-CoV-2 viral load in COVID-19 patients enrolled clinical studies. A liquid chromatography-multiple reaction monitoring-mass spectrometry (LC-MRM-MS)-based method, combined with trypsin rAspN dual enzymatic digestion, was developed for determination total REGN10933 REGN10987...
Abstract There is an urgent demand to develop new technologies characterize immunogenicity biotherapeutics. Here, we developed immunocapture LC-MS assay isotype and semi-quantify monkey anti-drug antibodies (ADAs) fully human monoclonal antibody (mAb) drugs. ADAs were isolated from serum samples using step with the Fab of full-length mAb cross-linked magnetic beads minimize matrix interference. A positive control against immunoglobulin kappa light chain was used as a calibration standard for...
Abstract The statistical assessments needed to establish anti-drug antibody (ADA) assay cut points (CPs) can be challenging for bioanalytical scientists. Poorly established CPs that are too high could potentially miss treatment emergent ADA or, when set low, result in detection of responses may have no clinical relevance. We evaluated 16 validation CP datasets generated with assays at Regeneron’s laboratory and compared results obtained from different calculation tools. systematically the...
Melanoma is the most lethal form of human skin cancer. However, only limited chemotherapy currently available for metastatic stage disease. Since chemotherapy, radiation and sodium arsenite treatment operate mainly through induction intrinsic mitochondrial pathway, a strongly decreased function in melanoma cells, could be responsible low efficacy conventional therapy melanoma. Another feature cells their proinflammatory phenotype, linked to endogenous expression inflammatory cytokines, such...
Development of anti-drug antibodies (ADAs) and neutralizing (NAbs) to monoclonal may adversely impact pharmacokinetics, efficacy, and/or safety.
Abstract This paper demonstrates the development of an analytical method for detecting steroid hormones by coupling HPLC to electrochemical detection, using a nickel‐modified glassy carbon electrode. The was evaluated in terms sensitivity, linear dynamic range, limit and response stability. developed exhibited good figures merit studied with no evidence electrode fouling. As example, detection ( S/N =3) E3 0.10 µM precision n =5) 0.6 %. application analysis real river water sample is demonstrated.
Background: Quantitating total levels of monoclonal antibody (mAb) biotherapeutics in serum using ELISA may be hindered by soluble targets. Results: We developed two low-pH-sample-pretreatment techniques to minimize target interference. The first procedure involves sample pretreatment at pH <3.0 before neutralization and analysis a capture ELISA. Careful monitoring acidification time is required potential impact on mAb detection. second approach dilution into mild acid (pH ∼4.5) transferring...
Aim: In response to the COVID-19 pandemic, Regeneron developed anti-SARS-CoV-2 monoclonal antibody cocktail, REGEN-COV® (RONAPREVE® outside USA). Drug concentration data was important for determination of dose, so a two-part bioanalytical strategy implemented ensure therapy rapidly available use. Results & methodology: Initially, liquid chromatography-multiple reaction monitoring-mass spectrometry (LC-MRM-MS) assay, used analyze early-phase study samples. Subsequently, validated...
Immunogenicity is recognized as a possible clinical risk due to the development of anti drug antibodies (ADAs) that can adversely impact safety and efficacy. Although robust assays are currently used assess ADA, there debate on how best generate most appropriate immunogenicity data. There several factors trigger ADA formation including immunity status target population severity disease indication. testing has defaulted conservative approach regardless inherent molecule or patient population....
A bridging immunogenicity assay for a human IgG4 mAb therapeutic was transferred to an automation system increase throughput. However, background signal increased five- six-fold during the 6- 8-h run.Noncovalent Fc contacts formed between labeled drugs in reagent solutions stored run. This generated substantial signal, reducing sensitivity by approximately sixfold. interactions also significantly impacted confirmation assay. and unlabeled drug, increasing inhibition (∼7-70%) 6-h run.Storing...
An assay measuring an IgG4 biotherapeutic in human serum used a drug-specific monoclonal antibody (mAb) capture reagent and antihuman mAb as detection reagent. However, binding to the via Fc-interactions was detected by anti-IgG4 mAb, causing high background.Two approaches were developed minimize background; incorporating mild acid sample preparation step or using Fab of antibody. Either strategy improved signal:noise dramatically, increasing sensitivity >20-fold. Biophysical analyses...