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https://www.readbyqxmd.com/read/29792967/validated-reverse-phase-hplc-diode-array-method-for-the-quantification-of-intact-bevacizumab-infliximab-and-trastuzumab-for-long-term-stability-study
#1
Antonio Martínez-Ortega, Agustín Herrera, Antonio Salmerón-García, José Cabeza, Luis Cuadros-Rodríguez, Natalia Navas
The aim of the present study was to develop suitable and reliable method for quantification three of the most worldwide used therapeutic monoclonal antibodies (mAbs) -bevazizumab (BVZ), infliximab (INF) and trastuzumab (TTZ)- to be used in long-term stability studies. Reverse phase (RP) was selected by its greater sensibility and reproducibility comparing with other chromatographic modes. Then a high performance liquid chromatography with diode array detection (RP)HPLC/DAD method was checked. Since the three mAbs represent the active ingredient in the medicines in which they are formulated, the selected method was validated for each one in accordance with the International Conference on Harmonization (ICH) guidelines for pharmaceuticals for human use...
May 21, 2018: International Journal of Biological Macromolecules
https://www.readbyqxmd.com/read/29791435/immunogenicity-and-efficacy-following-sequential-parenterally-administered-doses-of-salmonella-enteritidis-cops-flic-glycoconjugates-in-infant-and-adult-mice
#2
Scott M Baliban, Brittany Curtis, Deanna Toema, Sharon M Tennant, Myron M Levine, Marcela F Pasetti, Raphael Simon
In sub-Saharan Africa, invasive nontyphoidal Salmonella (iNTS) infections with serovars S. Enteritidis, S. Typhimurium and I 4,[5],12:i:- are widespread in children < 5 years old. Development of an efficacious vaccine would provide an important public health tool to prevent iNTS disease in this population. Glycoconjugates of S. Enteritidis core and O-polysaccharide (COPS) coupled to the homologous serovar phase 1 flagellin protein (FliC) were previously shown to be immunogenic and protected adult mice against death following challenge with a virulent Malian S...
May 23, 2018: PLoS Neglected Tropical Diseases
https://www.readbyqxmd.com/read/29789238/a-phase-1-study-of-safety-and-immunogenicity-following-intradermal-administration-of-a-tetravalent-dengue-vaccine-candidate
#3
Lisa A Jackson, Richard Rupp, Athanasia Papadimitriou, Derek Wallace, Marsha Raanan, Kelley J Moss
BACKGROUND: As part of the ongoing search for an effective dengue vaccine, Takeda performed a phase 1b study to investigate the safety and immunogenicity of an early low-dose tetravalent dengue vaccine candidate formulation (LD-TDV), based on an attenuated serotype 2 backbone, when administered intradermally with an injector device (PharmaJet®), or needle-syringe. METHODS: The study was performed in two centers in the US, in healthy 18-45 year old subjects with no history of dengue vaccination or disease...
May 19, 2018: Vaccine
https://www.readbyqxmd.com/read/29778196/vaccination-with-killed-whole-cells-of-escherichia-coli-o157-h7-hha-mutant-emulsified-with-an-adjuvant-induced-vaccine-strain-specific-serum-antibodies-and-reduced-e-coli-o157-h7-fecal-shedding-in-cattle
#4
Vijay K Sharma, Robert G Schaut, Crystal L Loving
Escherichia coli O157:H7 (O157) can cause from a mild diarrheal illness to hemorrhagic colitis and hemolytic uremic syndrome in humans. Cattle are the primary reservoir for O157 and fecal shedding of O157 by these animals is a major risk factor in contamination of cattle hides and carcasses at slaughter. Vaccination is an important strategy to reduce fecal shedding of O157 in cattle. In this study, we evaluated the immunogenicity and efficacy of an inactivated vaccine strain of O157 formulated with an adjuvant...
June 2018: Veterinary Microbiology
https://www.readbyqxmd.com/read/29777102/a-virus-like-particle-based-tetravalent-vaccine-for-hand-foot-and-mouth-disease-elicits-broad-and-balanced-protective-immunity
#5
Wei Zhang, Wenlong Dai, Chao Zhang, Yu Zhou, Pei Xiong, Shuxia Wang, Xiaohua Ye, Qingwei Liu, Dongming Zhou, Zhong Huang
Hand, foot, and mouth disease (HFMD) is an infectious disease that mainly affects infants and children, causing considerable morbidity and mortality worldwide. HFMD is commonly caused by enterovirus 71 (EV71) and coxsackieviruses A16 (CVA16), A6 (CVA6), and A10 (CVA10). Formalin-inactivated EV71 vaccines are currently available in China; however, these vaccines fail to confer cross-protection against infections by other HFMD-causing enteroviruses, highlighting the necessity of developing a multivalent HFMD vaccine...
May 18, 2018: Emerging Microbes & Infections
https://www.readbyqxmd.com/read/29769148/current-landscape-and-future-of-dual-anti-ctla4-and-pd-1-pd-l1-blockade-immunotherapy-in-cancer-lessons-learned-from-clinical-trials-with-melanoma-and-non-small-cell-lung-cancer-nsclc
#6
REVIEW
Young Kwang Chae, Ayush Arya, Wade Iams, Marcelo R Cruz, Sunandana Chandra, Jaehyuk Choi, Francis Giles
Immunotherapy is among the most rapidly evolving treatment strategies in oncology. The therapeutic potential of immune-checkpoint inhibitors is exemplified by the recent hail of Food and Drug Administration (FDA) approvals for their use in various malignancies. Continued efforts to enhance outcomes with immunotherapy agents have led to the formulation of advanced treatment strategies. Recent evidence from pre-clinical studies evaluating immune-checkpoint inhibitors in various cancer cell-lines has suggested that combinatorial approaches may have superior survival outcomes compared to single-agent immunotherapy regimens...
May 16, 2018: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/29769145/phylogenetic-relationships-stage-specific-expression-and-localisation-of-a-unique-family-of-inactive-cysteine-proteases-in-sarcoptes-scabiei
#7
Deepani D Fernando, Simone L Reynolds, Martha Zakrzewski, Ehtesham Mofiz, Anthony T Papenfuss, Deborah Holt, Katja Fischer
BACKGROUND: Scabies is worldwide one of the most common, yet neglected, parasitic skin infections, affecting a wide range of mammals including humans. Limited treatment options and evidence of emerging mite resistance against the currently used drugs drive our research to explore new therapeutic candidates. Previously, we discovered a multicopy family of genes encoding cysteine proteases with their catalytic sites inactivated by mutation (SMIPP-Cs). This protein family is unique in parasitic scabies mites and is absent in related non-burrowing mites...
May 16, 2018: Parasites & Vectors
https://www.readbyqxmd.com/read/29769118/protection-against-neonatal-enteric-colibacillosis-employing-e-coli-derived-outer-membrane-vesicles-in-formulation-and-without-vitamin-d3
#8
Babak Beikzadeh, Gholamreza Nikbakht Brujeni
OBJECTIVE: Enterotoxigenic Escherichia Coli (ETEC) is the cause of diarrhea and even death in humans and offspring of animals. Outer membrane vesicles (OMVs) of the ETEC was prepared and its potential as a vaccine candidate against enteric colibacillosis in neonatal mice was evaluated. Dam mice intradermally injected with ETEC-derived OMVs and OMVs plus an active form of vitamin D3 (avD3). Mucosal and systemic immune responses in mice and passive immunity protection against ETEC lethality in their offspring was investigated...
May 16, 2018: BMC Research Notes
https://www.readbyqxmd.com/read/29766232/waning-and-boosting-on-the-dynamics-of-immune-status
#9
O Diekmann, W F de Graaf, M E E Kretzschmar, P F M Teunis
The aim is to describe the distribution of immune status (as captured by antibody level) on the basis of a within-host submodel for continuous waning and occasional boosting. Inspired by Feller's fundamental work and the more recent delay equation formulation of models for the dynamics of physiologically structured populations, we derive, for given force of infection, a linear renewal equation. The solution is obtained by generation expansion, with the generation number corresponding to the number of times the individual became infected...
May 15, 2018: Journal of Mathematical Biology
https://www.readbyqxmd.com/read/29764431/cyclooxygenase-2-immunoexpression-in-intestinal-epithelium-and-lamina-propria-of-cats-with-inflammatory-bowel-disease-and-low-grade-alimentary-lymphoma
#10
Jorge Castro-López, Antonio Ramis, Marta Planellas, Mariana Teles, Josep Pastor
BACKGROUND: Cyclooxygenase 2 (COX-2) is an inducible isoform by cellular activation, proinflammatory cytokines and growth factors. The aims of the current study were to evaluate COX-2 immunoexpression in epithelial and lamina propria (LP) of cats with inflammatory bowel disease (IBD) and low grade alimentary lymphoma (LGAL), as well as to correlate them with clinical signs and histopathological scoring. Cats diagnosed with IBD and LGAL (2007-2013) were included in the current study. Feline chronic enteropathy activity index (FCEAI) was calculated for all cases...
May 15, 2018: BMC Veterinary Research
https://www.readbyqxmd.com/read/29761239/kinetics-and-characterization-of-non-enzymatic-fragmentation-of-monoclonal-antibody-therapeutics
#11
Sahithi Ravuluri, Rohit Bansal, Nidhi Chhabra, Anurag S Rathore
PURPOSE: To understand non-enzymatic hydrolytic fragmentation of a monoclonal antibody therapeutic under temperature stressed conditions and investigating possible mechanism for the same. METHODS: The mAb therapeutic was incubated at 50°C in phosphate buffer at pH 6.5 and fragmentation was monitored at different ionic strengths under stressed conditions. The incubated mAb was sampled at regular time intervals by analytical Size Exclusion Chromatography (SEC). RESULTS: It was observed that 57% of the mAb product fragmented over 4 days into two fragment species - Fc-Fab and Fab with molecular weights of 97 KDa and 47 KDa, respectively, as measured by mass spectrometry (MS) and sodium dodecyl sulphate-polyacrylamide gel electrophoresis (SDS-PAGE)...
May 14, 2018: Pharmaceutical Research
https://www.readbyqxmd.com/read/29757363/targeting-endothelial-ligands-icam-1-alicaforsen-madcam-1
#12
Walter Reinisch, Kenneth Hung, Mina Hassan-Zahraee, Fabio Cataldi
The specific blockade of the endothelial ligands intercellular adhesion molecule-1 (ICAM-1) and mucosal addressin cell adhesion molecule (MAdCAM) involved in leukocyte recruitment to the site of inflammation as therapeutic targets in inflammatory bowel disease (IBD) has been recognized from their overexpression in the inflamed mucosa and their successful intervention in preclinical animal models. Interventions to target ICAM-1 in human IBD are confined to the ICAM-1 anti-sense oligonucleotide alicaforsen. Whereas results with parenteral formulations of alicaforsen in Crohn's disease were largely negative, efficacy signals derived from studies with an enema formulation in ulcerative and pouchitis are promising and having lead to a FDA Fast-Track designation for the latter...
May 11, 2018: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/29750942/long-term-stability-of-a-hiv-1-neutralizing-monoclonal-antibody-using-isothermal-calorimetry
#13
Benjamin R Clarkson, Rajoshi Chaudhuri, Arne Schön, Lisa Kueltzo, Ernesto Freire
Different factors affect the long term stability of monoclonal antibodies, among them denaturation or partial denaturation that is often followed by aggregation. Isothermal calorimetry is capable of quantifying the kinetics of denaturation/aggregation of an antibody by measuring the heat that is released or absorbed by the process over a period of days or weeks, at temperatures below its denaturation temperature, Tm . The denaturation/aggregation kinetics of the anti-HIV monoclonal antibody VRC07-523LS was measured by isothermal calorimetry at different concentrations in four different formulation buffers...
May 8, 2018: Analytical Biochemistry
https://www.readbyqxmd.com/read/29746518/an-ambient-temperature-stable-antitoxin-of-nine-co-formulated-antibodies-for-botulism-caused-by-serotypes-a-b-and-e
#14
Mingxiang Li, Dennis Lee, Chidi R Obi, Joel K Freeberg, Shauna Farr-Jones, Milan T Tomic
Safe and effective antitoxins to treat and prevent botulism are needed for biodefense. We have developed recombinant antibody-based therapeutics for botulinum neurotoxin (BoNT) serotypes A, B, and E. The mechanism of action of this antitoxin requires that three mAbs bind one toxin molecule to achieve clearance. Here we present a co-formulation of an antitoxin to the three most important serotypes. Combining these antibodies obviates the need to identify the serotype causing intoxication prior to drug administration, which would facilitate administration...
2018: PloS One
https://www.readbyqxmd.com/read/29745243/bevacizumab-for-epistaxis-in-hereditary-hemorrhagic-telangiectasia-an-evidence-based-review
#15
Ashleigh A Halderman, Matthew W Ryan, Bradley F Marple, Raj Sindwani, Douglas D Reh, David M Poetker
Objective Epistaxis is a primary complaint in 90% to 96% of patients with hereditary hemorrhagic telangiectasia (HHT). Numerous surgical and medical treatments aim to decrease the frequency and severity of epistaxis in this patient population. Bevacizumab is a recombinant, humanized monoclonal antibody to vascular endothelial growth factor, an angiogenic factor elevated in HHT. It has been used in several forms to treat epistaxis in HHT but thus far, evidence-based recommendations are limited. Study Design Systematic review with evidence-based recommendations...
January 1, 2018: American Journal of Rhinology & Allergy
https://www.readbyqxmd.com/read/29742893/synthesis-liposomal-formulation-and-immunological-evaluation-of-a-minimalistic-carbohydrate-%C3%AE-galcer-vaccine-candidate
#16
Felix Broecker, Sebastian Götze, Jonathan Hudon, Dominea C K Rathwell, Claney L Pereira, Pierre Stallforth, Anish Chakkumkal, Peter H Seeberger
Fully synthetic glycan-based vaccines hold great potential as preventive and therapeutic vaccines against infectious diseases as well as cancer. Here, we present a two-component platform based on the facile conjugation of carbohydrate antigens to α-galactosylceramide (α-GalCer) to yield fully synthetic vaccine candidates. Formulation of a cancer-associated Tn antigen glycolipid model vaccine candidate into liposomes of different sizes and subsequent immunization of mice generated specific, high-affinity antibodies against the carbohydrate antigen with characteristics of T cell-dependent immunity...
May 9, 2018: Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/29740758/spray-freeze-drying-a-suitable-method-for-aerosol-delivery-of-antibodies-in-the-presence-of-trehalose-and-cyclodextrins
#17
Maryam Amini Pouya, Behnaz Daneshmand, Shabnam Aghababaie, Homa Faghihi, Alireza Vatanara
We aimed to prepare spray-freeze-dried powder of IgG considering physicochemical stability and aerodynamic aspects. Spray-freeze drying (SFD) exposes proteins to various stresses which should be compensated by suitable stabilizers. The competence of cyclodextrins (CDs), namely beta-cyclodextrin (βCD) and hydroxypropyl βCD (HPβCD), at very low concentrations, was investigated in the presence of separate mannitol- and trehalose-based formulations. Spray-freeze-dried preparations were quantified in terms of monomer recovery and conformation by size exclusion chromatography (SEC-HPLC) and Fourier transform infrared (FTIR) spectroscopy, respectively...
May 8, 2018: AAPS PharmSciTech
https://www.readbyqxmd.com/read/29739720/heterologous-prime-boost-vaccination-with-adenoviral-vector-and-protein-nanoparticles-induces-both-th1-and-th2-responses-against-middle-east-respiratory-syndrome-coronavirus
#18
Seo-Yeon Jung, Kyung Won Kang, Eun-Young Lee, Dong-Won Seo, Hong-Lim Kim, Hak Kim, TaeWoo Kwon, Hye-Lim Park, Hun Kim, Sang-Myeong Lee, Jae-Hwan Nam
The Middle East respiratory syndrome coronavirus (MERS-CoV) is a highly pathogenic and zoonotic virus with a fatality rate in humans of over 35%. Although several vaccine candidates have been developed, there is still no clinically available vaccine for MERS-CoV. In this study, we developed two types of MERS-CoV vaccines: a recombinant adenovirus serotype 5 encoding the MERS-CoV spike gene (Ad5/MERS) and spike protein nanoparticles formulated with aluminum (alum) adjuvant. Next, we tested a heterologous prime-boost vaccine strategy, which compared priming with Ad5/MERS and boosting with spike protein nanoparticles and vice versa, with homologous prime-boost vaccination comprising priming and boosting with either spike protein nanoparticles or Ad5/MERS...
May 5, 2018: Vaccine
https://www.readbyqxmd.com/read/29736301/surrogate-potency-assays-comparison-of-binding-profiles-complements-dose-response-curves-for-unambiguous-assessment-of-relative-potencies
#19
Robert Karlsson, Veronica Fridh, Åsa Frostell
Surface plasmon resonance (SPR) systems are widely used for detailed characterization of antibody activities including antigen and Fc-receptor binding. During the later stages of development, where the focus is to ensure that established critical quality attributes (CQAs) are maintained during cell culture, purification and formulation processes, analysis is simplified, and relative potencies are often determined. Here, simulation of binding data revealed that relative potency values, determined via parallel line analysis (PLA) and half maximal effective concentration (EC50) analysis accurately reflect changes in active concentration only if binding kinetics remain unchanged...
April 2018: Journal of Pharmaceutical Analysis
https://www.readbyqxmd.com/read/29733876/magnetically-driven-drug-delivery-systems-improving-targeted-immunotherapy-for-colon-rectal-cancer
#20
Renata Grifantini, Monia Taranta, Lisa Gherardini, Ilaria Naldi, Matteo Parri, Alberto Grandi, Ambra Giannetti, Sara Tombelli, Gioia Lucarini, Leonardo Ricotti, Susanna Campagnoli, Elisa De Camilli, Gualtiero Pelosi, Francesco Baldini, Arianna Menciassi, Giuseppe Viale, Piero Pileri, Caterina Cinti
Colorectal cancer (CRC) is one of the major causes of cancer-associated mortality worldwide. The currently approved therapeutic agents show a rather limited efficacy. We have recently demonstrated that the atypical cadherin FAT1 is a specific marker of CRC and that the FAT1-specific monoclonal antibody mAb198.3 may offer new therapeutic opportunities for CRC, being efficiently internalized by cancer cells and reducing cancer growth in colon cancer xenograft models. In this study we explored the therapeutic efficacy of mAb198...
May 4, 2018: Journal of Controlled Release: Official Journal of the Controlled Release Society
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