A5076422120- Biosimilars and Bioanalytical Methods
- Monoclonal and Polyclonal Antibodies Research
- Advanced Biosensing Techniques and Applications
- Biosensors and Analytical Detection
- Occupational and environmental lung diseases
- Protein purification and stability
- Transgenic Plants and Applications
- Bacteriophages and microbial interactions
- Plant tissue culture and regeneration
- Advanced biosensing and bioanalysis techniques
- Pleural and Pulmonary Diseases
- vaccines and immunoinformatics approaches
- Clinical Laboratory Practices and Quality Control
- RNA Interference and Gene Delivery
- Pneumocystis jirovecii pneumonia detection and treatment
- Endometrial and Cervical Cancer Treatments
- Respiratory viral infections research
- Toxin Mechanisms and Immunotoxins
- Microfluidic and Capillary Electrophoresis Applications
- Plant Virus Research Studies
- Pneumonia and Respiratory Infections
- Computational Drug Discovery Methods
- Cancer Research and Treatments
- Ovarian cancer diagnosis and treatment
- Viral gastroenteritis research and epidemiology
United States Military Academy
2010-2024
Merck & Co., Inc., Rahway, NJ, USA (United States)
2011-2022
Merck (Germany)
2018
Swift Engineering (United States)
2014
MBio Diagnostics (United States)
2006-2009
University of Pennsylvania
2004-2007
Weatherford College
2007
Thomas Jefferson University
1998-2003
California University of Pennsylvania
2003
Analytical methods are utilized throughout the biopharmaceutical and vaccines industries to conduct research development, help control manufacturing inputs outputs. These analytical should continuously provide quality data support decisions while managing remaining of risk uncertainty. by design (AQbD) can a systematic framework achieve validated, robust assay as well life cycle management. AQbD is rooted in ICH guidelines Q8 Q9 that were translated space through several white papers...
Soluble mesothelin-related peptides (SMRP)have been reported to be potential biomarkers for malignant pleural mesothelioma (MPM). We report analytical and preliminary clinical studies of MESOMARK, a quantitative assay SMRP.The MESOMARK is 2-step immunoenzymatic in an ELISA format with 6-point calibration curve (0-32 nmol/L). assessed imprecision, analyte stability, interferences. measured SMRP by this 409 apparently healthy individuals (reference interval study), 177 patients nonmalignant...
Abstract The mesothelin family comprises (at least) three variants and includes the precursor for megakaryocyte potentiating factor (MPF). Assaying soluble mesothelin-related protein (SMRP) molecules in serum other body fluids from patients with certain cancers can provide diagnostically useful information. We have constructed fusion proteins of 1, 2, 3, made monoclonal antibodies, investigated binding specificity these previously generated antibodies to each variants. According flow...
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...
ABSTRACT Plasmids represent a powerful tool to rapidly introduce genes into bacteria and help them reach high expression levels. In vaccine development, with live vectors, this allows greater flexibility the ability induce larger antigen amounts through multiple gene copies. However, plasmid retention often requires antibiotic resistance markers, presence of which has been discouraged in clinical applications by Food Drug Administration. Therefore, we developed Listeria monocytogenes -...
Diagnosis of malignant pleural mesothelioma (MM) is limited. Novel proteomic techno_logies can be utilized to discover changes in expression proteins that might have diagnostic value. The objective this study was detect protein profiles could used identify with surface enhanced laser desorption/ionization time-of-flight (SELDI-TOF) mass spectrometry (MS). Pleural effusions were collected from patients confirmed (n = 41) and due other causes ([n 48] cancerous non-cancerous). Samples...
Measuring vaccine potency is critical for release and often accomplished using antibody-based ELISAs. Antibodies can be associated with significant drawbacks that are overlooked including lot-to-lot variability, problems cell-line maintenance, limited stability, high cost, long discovery lead times. Here, we address many of these issues through the development an aptamer, known as a slow off-rate modified DNA aptamer (SOMAmer), which targets antigen in human papillomavirus (HPV) Gardasil....
The development of an effective therapeutic vaccine to induce cancer-specific immunity remains unsolved yet pressing priority requiring novel strategies. Here we have generated a series vaccines in which bacteria deliver plasmid encoding tumor antigen under the control mammalian promoter attempt antitumor immune response. Utilizing release mechanism involving suicide carrier bacteria, were able engineer Listeria monocytogenes physiologically relevant antigen, cervical cancer oncoprotein E7....
Most human ovarian carcinomas express mesothelin, which is shed as a diagnostically useful biomarker. We applied an ELISA to measure antibodies native mesothelin in serum from series of patients with divergent clinical outcomes. The level anti-mesothelin determined OD(450 nm) and referred absorption units (AU) for 1:20 diluted was higher who remained disease-free after therapy [no evidence disease (NED); n = 14] than whose recurred [clinical (CED); 21; P < 0.01]. Applying AU > or 0.5 at...
Selection and characterization of antibodies are critically important in establishing robust immunoassays to support the development efforts vaccines. Plate-based ELISA can be time- resource-intensive select initial antibody clones or characterize downstream resupply lots while providing limited information regarding binding characteristics beyond concentration–response curves. This work applied microfluidic Gyrolab holistically evaluate immunoassay reagents through analyses curves as well...
Serotype-specific assays detecting pneumococcal polysaccharides in bodily fluids are needed to understand the serotype distribution non-bacteremic pneumonia.
The urgency and importance of organizing a global effort to harmonize clinical assay validation specific the vaccine industry was identified during drafting 2020 White Paper in Bioanalysis due lack clarity regulatory guidance/guidelines immunoassay validation. Indeed, Workshop on Recent Issues (WRIB) issues yearly, which is one high-profile articles Journal focused detailed discussions recommendations Since 2017, participation WRIB working groups by experts regulators has rapidly increased...
Community-acquired pneumonia is a leading infectious cause of hospitalization. A few vaccines exist to prevent pneumococcal disease in adults, including polysaccharide unconjugated vaccine and protein conjugated vaccine. Previous studies on the human immune response showed that boosted existing memory B cells. In present study, we investigated cell following conjugate vaccination.Plasmablast cells from vaccinee were isolated cloned for analysis. primary vaccination, identical sequences...
Mesothelioma is a highly progressive tumor with poor prognosis. In this article, the authors give thorough introduction into and evaluation of MESOMARK(®) in vitro test - only blood for management patients mesothelioma approved by US FDA. Europe, Australia, New Zealand Canada, or licensed measurement soluble mesothelin, also termed as mesothelin-related peptides. US, it monitoring epithelioid biphasic malignant mesothelioma.
Background: As quality by design (QbD) for pharmaceutical product development is being expanded to include analytical methods, we applied QbD the of antigenicity assays measuring in vitro relative potency a quadrivalent vaccine candidate. Results: After establishing targets together with customers, immunoassays were developed meet objectives. Statistical experiments was used optimize method parameters and establish space. Systematic risk analysis enabled identification potential risks...