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https://www.readbyqxmd.com/read/28445969/glypican-1-targeted-antibody-based-therapy-induces-preclinical-antitumor-activity-against-esophageal-squamous-cell-carcinoma
#1
Emi Harada, Satoshi Serada, Minoru Fujimoto, Yusuke Takahashi, Tsuyoshi Takahashi, Hisashi Hara, Rie Nakatsuka, Takahito Sugase, Takahiko Nishigaki, Yurina Saito, Kosuke Hiramatsu, Satoshi Nojima, Risa Mitsuo, Tomoharu Ohkawara, Eiichi Morii, Masaki Mori, Yuichiro Doki, Yasufumi Kaneda, Tetsuji Naka
Esophageal squamous cell carcinoma (ESCC) has a poor prognosis despite the development of multimodal therapy. Expression of glypican-1 (GPC1) has been reported to be elevated in a subset of patients with ESCC and associated with chemoresistance. This study aimed to determine the association of GPC1 with ESCC growth and potential usefulness of the GPC1 targeted therapy by monoclonal antibody (mAb) in ESCC. Expression of GPC1 was higher in ESCC tumor tissues than in adjacent non-tumoral tissues and normal tissues...
April 11, 2017: Oncotarget
https://www.readbyqxmd.com/read/28444889/invasive-fungal-infections-in-paediatric-patients-treated-with-macromolecular-immunomodulators-other-than-tumour-necrosis-alpha-inhibitors
#2
REVIEW
Ioannis Kyriakidis, Athanasios Tragiannidis, Ilse Zündorf, Andreas H Groll
An expanding list of immunomodulatory or immunosuppressive monoclonal antibodies (mAbs) and biologic therapeutics is currently entering clinical practice, particularly in the areas of oncology, transplantation and autoimmune disorders. These agents are directed against molecules or cells involved in inflammation and immunity and may therefore be associated with serious and opportunistic infections. The purpose of this review was to critically analyse the literature on invasive fungal infections (IFIs) occurring in association with mAbs and fusion proteins other than tumour necrosis alpha (TNF-α) inhibitors, including therapeutics modulating T-cell-mediated pathologies (muromonab, abatacept, belatacept, ipilimumab, basiliximab, daclizumab), inducing lymphopenia (alemtuzumab), depleting CD20+ B cells (rituximab) and interfering with various targets (anakinra, natalizumab, blodalumab, ixekizumab and others) with a focus on children, and to provide a framework of evaluating the risk for IFIs in this population...
April 26, 2017: Mycoses
https://www.readbyqxmd.com/read/28442372/long-term-release-and-stability-of-pharmaceutical-proteins-delivered-from-solid-lipid-implants
#3
Moritz Vollrath, Julia Engert, Gerhard Winter
Solid lipid implants (SLIs) prepared by twin-screw (tsc) extrusion represent a promising technology platform for the sustained release of pharmaceutical proteins. In this work, we report on two aspects, long-term release and stability of released protein. First, SLIs were produced by tsc-extrusion containing the low melting triglyceride H12 and the high melting triglyceride Dynasan D118. Two different proteins available in a freeze-dried matrix containing hydroxypropyl-β-cyclodextrine (HP-β-CD) were incorporated into the lipid matrix: a monoclonal antibody (mAb) from the IgG1 class and the fab-fragment Ranibizumab (Lucentis(®))...
April 22, 2017: European Journal of Pharmaceutics and Biopharmaceutics
https://www.readbyqxmd.com/read/28442345/characterization-of-a-recombinant-humanized-anti-cocaine-antibody-produced-from-multiple-clones-for-the-selection-of-a-master-cell-bank-candidate
#4
Hanna N Wetzel, Rose P Webster, Fatima Saeed, Terence L Kirley, William J Ball, Andrew B Norman
We have generated a humanized anti-cocaine monoclonal antibody (mAb), which is at an advanced stage of pre-clinical development. We report here in vitro binding affinity studies, and in vivo pharmacokinetic and efficacy studies of the recombinant mAb. The overall aim was to characterize the recombinant antibody from each of the three highest producing transfected clones and to select one to establish a master cell bank. In mAb pharmacokinetic studies, after injection with h2E2 (120 mg/kg iv) blood was collected from the tail tip of mice over 28 days...
April 22, 2017: Biochemical and Biophysical Research Communications
https://www.readbyqxmd.com/read/28440708/towards-in-vitro-to-in-vivo-translation-of-monoclonal-antibody-pharmacokinetics-application-of-a-neonatal-fc-receptor-mediated-transcytosis-assay-to-understand-the-interplaying-clearance-mechanisms
#5
Claudia A Castro Jaramillo, Sara Belli, Anne-Christine Cascais, Sherri Dudal, Martin R Edelmann, Markus Haak, Marie-Elise Brun, Michael B Otteneder, Mohammed Ullah, Christoph Funk, Franz Schuler, Silke Simon
Monoclonal antibodies (mAbs) are a rapidly growing drug class for which great efforts have been made to optimize certain molecular features in order to achieve the desired pharmacokinetic (PK) properties. One approach is to engineer the interactions of the mAb with the neonatal Fc receptor (FcRn) by introducing specific amino acid sequence mutations, and to assess their effect on the PK profile with in vivo studies. Indeed, FcRn protects mAbs from intracellular degradation, thereby prolongs antibody circulation time in plasma and modulates its systemic clearance...
April 25, 2017: MAbs
https://www.readbyqxmd.com/read/28440060/a-practical-approach-in-bioreactor-scale-up-and-process-transfer-using-a-combination-of-constant-p-v-and-vvm-as-the-criterion
#6
Sen Xu, Linda Hoshan, Rubin Jiang, Balrina Gupta, Eric Brodean, Kristin O'Neill, T Craig Seamans, John Bowers, Hao Chen
Bioreactor scale-up is a critical step in the production of therapeutic proteins such as monoclonal antibodies (MAbs). With the scale-up criterion such as similar power input per volume or O2 volumetric mass transfer coefficient (kL a), adequate oxygen supply and cell growth can be largely achieved. However, CO2 stripping in the growth phase is often inadequate. This could cascade down to increased base addition and osmolality, as well as residual lactate increase and compromised production and product quality...
April 25, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/28439933/effect-of-anti-ige-in-occupational-asthma-caused-by-exposure-to-low-molecular-weight-agents
#7
M Ollé-Monge, M J Cruz, S Gomez-Ollés, I Ojanguren, J Vanoirbeek, X Muñoz
BACKGROUND: The role of immunoglobulin (Ig)-E in occupational asthma (OA) due to low molecular weight (LMW) agents is not well established compared to classical atopic asthma. In the present study we evaluate whether anti-IgE monoclonal antibody (mAb) has an effect in a mouse model of OA, using persulfate salts. METHODS: On days 1 and 8, BALB/C mice were dermally sensitized with 5% ammonium persulfate (AP) or dimethyl sulfoxide (DMSO). On days 15, 18 and 21 animals were injected intraperitoneally with anti-IgE mAb or PBS 6 hours before challenge with AP or saline...
April 25, 2017: Allergy
https://www.readbyqxmd.com/read/28439684/impact-of-altered-endogenous-igg-on-unspecific-mab-clearance
#8
Saskia Fuhrmann, Charlotte Kloft, Wilhelm Huisinga
Immunodeficient mice are crucial models to evaluate the efficacy of monoclonal antibodies (mAbs). When studying mAb pharmacokinetics (PK), protection from elimination by binding to the neonatal Fc receptor (FcRn) is known to be a major process influencing the unspecific clearance of endogenous and therapeutic IgG. The concentration of endogenous IgG in immunodeficient mice, however is reduced, and this effect on the FcRn protection mechanism and subsequently on unspecific mAb clearance is unknown, yet of great importance for the interpretation of mAb PK data...
April 24, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28438994/latently-and-uninfected-healthcare-workers-exposed-to-tb-make-protective-antibodies-against-mycobacterium-tuberculosis
#9
Hao Li, Xing-Xing Wang, Bin Wang, Lei Fu, Guan Liu, Yu Lu, Min Cao, Hairong Huang, Babak Javid
The role of Igs in natural protection against infection by Mycobacterium tuberculosis (Mtb), the causative agent of TB, is controversial. Although passive immunization with mAbs generated against mycobacterial antigens has shown protective efficacy in murine models of infection, studies in B cell-depleted animals only showed modest phenotypes. We do not know if humans make protective antibody responses. Here, we investigated whether healthcare workers in a Beijing TB hospital-who, although exposed to suprainfectious doses of pathogenic Mtb, remain healthy-make antibody responses that are effective in protecting against infection by Mtb...
April 24, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/28438974/b-anthracis-edema-toxin-increases-fractional-free-water-and-sodium-reabsorption-in-an-isolated-perfused-rat-kidney-model
#10
Dharmvir S Jaswal, Xizhong Cui, Parizad Torabi-Parizi, Lernik Ohanjanian, Hannish Sampath-Kumar, Yvonne Fitz, Yan Li, Wanying Xu, Peter Q Eichacker
Introduction:B. anthracis edema toxin (ET) consists of protective antigen (PA), necessary for host cell toxin uptake, and edema factor (EF), the toxic moiety which increases host cell cAMP. Since vasopressin stimulates renal water and sodium reabsorption via increased tubular cell cAMP, we hypothesized ET would also. To test this hypothesis, we employed an isolated perfused rat kidney model. Methods and Results: Kidneys were isolated and perfused with modified Krebs-Henseleit. Perfusate and urine samples were obtained at baseline and every 10 minutes over 150 minutes following addition to the perfusate of challenges with or without treatments...
April 24, 2017: Infection and Immunity
https://www.readbyqxmd.com/read/28438386/catabolism-of-antibody-drug-conjugates-and-characterization-methods
#11
REVIEW
Mohammad Shadid, Stephen Bowlin, Jayaprakasam Bolleddula
Antibody drug conjugates (ADCs) are large molecule therapeutics in which a cytotoxic payload is conjugated to a monoclonal antibody (mAb) via a linker. The molecules are designed to selectively bind to target-expressing cells, thus delivering therapeutic agents directly to the tumor. Chemical and enzymatic stability prior to reaching the target is an important factor for ADCs since it impacts their safety, efficacy, and pharmacokinetics (PK). One of the main reasons for off-target effects of ADCs is premature release of cytotoxic agents, either in the blood stream or at non-specific sites...
April 11, 2017: Bioorganic & Medicinal Chemistry
https://www.readbyqxmd.com/read/28436007/overexpression-of-the-regulatory-subunit-of-glutamate-cysteine-ligase-enhances-monoclonal-antibody-production-in-cho-cells
#12
Camila A Orellana, Esteban Marcellin, Peter P Gray, Lars K Nielsen
For decades, Chinese hamster ovary (CHO) cells have been the preferred host for therapeutic monoclonal antibody (mAb) production; however, increasing mAb titer by rational engineering remains a challenge. Our previous proteomic analysis in CHO cells suggested that a higher content of glutathione (GSH) might be related to higher productivity. GSH is an important antioxidant, cell detoxifier, and is required to ensure the formation of native disulfide bonds in proteins. To investigate the involvement of GSH in mAb production, we generated stable CHO cell lines overexpressing genes involved in the first step of GSH synthesis; namely the glutamate-cysteine ligase catalytic subunit (Gclc) and the glutamate-cysteine ligase modifier subunit (Gclm)...
April 24, 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/28435294/patient-considerations-in-metastatic-colorectal-cancer-role-of-panitumumab
#13
REVIEW
Jane E Rogers
Epidermal growth factor receptor (EGFR) is overexpressed in many malignancies, including colorectal cancer (CRC), making EGFR an attractive treatment option. Panitumumab and cetuximab, monoclonal antibodies (mAbs) directed at EGFR, are both currently utilized in the management of metastatic CRC (mCRC). Through the development of these agents in mCRC, key issues surrounding each mAbs use have been revealed. These key issues include negative patient outcome avoidance when determining use, the economic burden with high-cost medication, predictive biomarkers, tumor location, patient geographic location, patient quality of life, and the prevention of debilitating adverse effects...
2017: OncoTargets and Therapy
https://www.readbyqxmd.com/read/28434982/novel-monoclonal-antibodies-against-stx1d-and-1e-and-their-use-for-improving-immunoassays
#14
Xiaohua He, Stephanie Patfield, Reuven Rasooly, Daniela Mavrici
Shiga toxins (Stxs) are major causative agents for bloody diarrhea and hemolytic uremic syndrome, a life-threatening disease in humans. No effective treatment is available. Early detection of Stxs in clinical samples is critical for disease management. As bacteria evolve, new Stxs are produced; therefore, methods used to identify them need to be improved as well. In this study, new monoclonal antibodies (mAbs) against Stx1d and 1e were developed and used to improve a commercial Stx1 kit. Incorporation of the new mAbs into the Abraxis Stx1 kit not only increased the assay sensitivity to Stx1d, but the assay was conferred the ability to detect Stx1e, a newly identified subtype of Stx1 produced by an atypical Stx-producing bacterial strain, Enterobacter cloacae M12X01451, isolated from a clinical specimen...
April 20, 2017: Journal of Immunological Methods
https://www.readbyqxmd.com/read/28433716/development-of-a-monoclonal-antibody-against-the-cd3%C3%AE%C2%B5-of-olive-flounder-paralichthys-olivaceus-and-its-application-in-evaluating-immune-response-related-to-cd3%C3%AE%C2%B5
#15
Jae Wook Jung, Jung Seok Lee, Young Rim Kim, Se Pyeong Im, Si Won Kim, Jassy Mary S Lazarte, Jaesung Kim, Kim D Thompson, Jong Pyo Suh, Tae Sung Jung
The T cell receptor (TCR) is the binding site of antigen and is responsible for specifically activating the adaptive immune response. CD3, an essential component of the CD3-TCR complex, is known to be composed of γδ and ε chains in teleost. However, there are few monoclonal antibodies (mAb) available to identify these molecules on T cells, so we aimed to produce a mAb against CD3ε to improve our understanding of T cell immune response in olive flounder (Paralichthys olivaceus). CD3ε recombinant protein was expressed in yeast, the expression of which was confirmed by SDS-PAGE, MALDI-TOF/TOF MS and Western blot analysis...
April 19, 2017: Fish & Shellfish Immunology
https://www.readbyqxmd.com/read/28433633/angiotensin-converting-enzyme-2-is-a-potential-therapeutic-target-for-egfr-mutant-lung-adenocarcinoma
#16
Miki Yamaguchi, Sachie Hirai, Toshiyuki Sumi, Yusuke Tanaka, Makoto Tada, Yukari Nishii, Tadashi Hasegawa, Hiroaki Uchida, Gen Yamada, Atsushi Watanabe, Hiroki Takahashi, Yuji Sakuma
EGFR-mutant lung adenocarcinomas contain a subpopulation of cells that have undergone epithelial-to-mesenchymal transition and can grow independently of EGFR. To kill these cancer cells, we need a novel therapeutic approach other than EGFR inhibitors. If a molecule is specifically expressed on the cell surface of such EGFR-independent EGFR-mutant cancer cells, it can be a therapeutic target. We found that a mesenchymal EGFR-independent subline derived from HCC827 cells, an EGFR-mutant lung adenocarcinoma cell line, expressed angiotensin-converting enzyme 2 (ACE2) to a greater extent than its parental cells...
April 19, 2017: Biochemical and Biophysical Research Communications
https://www.readbyqxmd.com/read/28433587/pharmacokinetic-and-toxicology-comparator-testing-of-biosimilar-drugs-assessing-need
#17
Paul Baldrick
A key element in the development of a biosimilar molecule is the comparability of the biological activity/nonclinical similarity to the innovator drug. Although some regulatory guidelines are encouraging little or no in vivo testing, currently a common practice is to perform at least one toxicology and/or one pharmacokinetic (PK) study to assess if any different findings occur for in-life, clinical pathology and histopathological parameters or in exposure. An exercise was performed in which the results of such testing were evaluated...
April 20, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28433527/characterization-of-leukocyte-subsets-in-buffalo-bubalus-bubalis-with-cross-reactive-monoclonal-antibodies-specific-for-bovine-mhc-class-i-and-class-ii-molecules-and-leukocyte-differentiation-molecules
#18
Francesco Grandoni, Mahmoud M Elnaggar, Gaber S Abdellrazeq, Federica Signorelli, Lindsay M Fry, Cinzia Marchitelli, Victoria Hulubei, Samy A Khaliel, Helmy A Torky, William C Davis
Although buffaloes (Bubalus bubalis) are a major component of the livestock industry worldwide, limited progress has been made in the study of the mechanisms regulating the immune response to pathogens and parasites affecting their health and productivity. This has been, in part, attributable to the limited availability of reagents to study immune responses in buffalo. As reported here, a set of cross-reactive monoclonal antibodies (mAbs), developed against bovine, ovine and caprine leukocyte differentiation molecules (LDM) and major histocompatibility complex (MHC) molecules, were identified and used to compare expression of LDM in Italian and Egyptian buffalo...
April 20, 2017: Developmental and Comparative Immunology
https://www.readbyqxmd.com/read/28432000/determination-of-thiol-to-protein-ratio-and-drug-to-antibody-ratio-by-in-line-size-exclusion-chromatography-with-post-column-reaction
#19
Kenichiro Furuki, Toshimasa Toyo'oka
An in-line size-exclusion (SE) ultra-high-performance liquid chromatography (UHPLC)- 5,5-dithio-bis-(2-nitrobenzoic acid) (DTNB) method to quantify thiols in monoclonal antibodies (mAb) when manufacturing antibody-drug conjugates (ADCs) was developed. The mAbs are separated on an SE-UHPLC column and monitored with a UV detector at a wavelength of 280 nm. Eluents are channeled into a reaction coil and mixed with DTNB to form 5-thio-2-nitrobenzoic acid (TNB). Thiol concentration is calculated using absorption at 412 nm...
April 18, 2017: Analytical Biochemistry
https://www.readbyqxmd.com/read/28431324/achievable-separation-performance-and-analysis-time-in-current-liquid-chromatographic-practice-for-monoclonal-antibody-separations
#20
Szabolcs Fekete, Jean-Luc Veuthey, Davy Guillarme
The separation performance of a chromatographic system is often described in terms of column efficiency and peak capacity. Thanks to the new developments in column technology over the past few years, the achievable peak capacity drastically improved and the analysis time can be significantly shortened. Indeed, highly efficient wide-pore reversed-phase (RPLC) materials packed with small fully porous and superficially porous particles can be successfully used for the analytical characterization of therapeutic proteins...
April 12, 2017: Journal of Pharmaceutical and Biomedical Analysis
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