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https://www.readbyqxmd.com/read/28637081/molecular-characterization-of-gluten-hydrolyzing-bacillus-spp-and-their-efficacy-and-biotherapeutic-potential-as-probiotics-using-caco-2-cell-line
#1
B S Rashmi, Gayathri Devaraja
AIM: To isolate and characterize indigenous gluten hydrolyzing bacteria from wheat sourdough and curd samples and further evaluation of their probiotic potentiality. METHODS AND RESULTS: Indigenous gluten hydrolyzing isolates GS 33, GS 143, GS 181 and GS 188 were identified as Bacillus spp. by molecular-typing methods and studied extensively for their functional and probiotic attributes. All the tested isolates could survive at pH 2 and toxicity of 0.3% bile and also exhibited cell-surface hydrophobicity and autoaggregation phenotype...
June 21, 2017: Journal of Applied Microbiology
https://www.readbyqxmd.com/read/28634022/goals-and-objectives-of-the-italian-network-for-tumor-biotherapy-nibit
#2
Vincenzo Russo, Alberto Amadori, Marco Bregni, Luana Calabrò, Mario Paolo Colombo, Massimo Di Nicola, Pier Francesco Ferrucci, Enrico Proietti, Michele Maio, Matteo Bellone
The explosion in the immuno-oncology field, exemplified by the clinical implementation of immune checkpoint inhibitor blockade and other immunotherapeutic strategies was quickly recognized by the Italian biomedical community, thanks to the networking activities of the Italian Network for Tumor Biotherapy (NIBIT), which has been active since 2004 in the diffusion of new scientific and clinical findings in the fields of tumor immunology and immunotherapy. Numerous activities of NIBIT have also helped to overcome the hurdles associated with the clinical implementation of cancer immune-biotherapeutic strategies at the national and international levels...
June 16, 2017: Cytokine & Growth Factor Reviews
https://www.readbyqxmd.com/read/28624430/comparative-assessment-of-immune-complex-mediated-hypersensitivity-reactions-with-biotherapeutics-in-the-non-human-primate-critical-parameters-safety-and-lessons-for-future-studies
#3
Sven Kronenberg, Elisabeth Husar, Christine Schubert, Christian Freichel, Thomas Emrich, Martin Lechmann, Anna Maria Giusti, Franziska Regenass
With the emergence of novel biotherapeutic formats and immunostimulatory biotherapeutics in cancer immunotherapy, an understanding of immune-complex (IC) mediated hypersensitivity reactions in toxicology studies - and their differentiation from pharmacology - remains key to the preclinical evaluation of these drugs. In this review we provide an in-depth evaluation and comparison of case examples where IC-mediated hypersensitivity reactions were observed in cynomolgus monkeys. We provide details of the parameters evaluated in each study to substantiate and guide the interpretation of these findings...
June 15, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28622622/characterization-of-drug-load-variants-in-a-thiol-linked-antibody-drug-conjugate-using-multidimensional-chromatography
#4
Jonathan J Gilroy, Catherine M Eakin
The biological complexity associated with biotherapeutics such as antibody-drug conjugates (ADCs) requires extensive characterization to ensure product quality consistency, safety, and efficacy. ADCs generated via partial reduction of antibody interchain disulfide bonds result in a distribution of variants containing 0-8 conjugated drugs. Hydrophobic interaction chromatography (HIC) is a key analytical technique used to separate drug load variants of thiol linked ADCs and to calculate the average drug-to-antibody molar ratio (DAR)...
June 4, 2017: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/28607051/computationally-optimized-deimmunization-libraries-yield-highly-mutated-enzymes-with-low-immunogenicity-and-enhanced-activity
#5
Regina S Salvat, Deeptak Verma, Andrew S Parker, Jack R Kirsch, Seth A Brooks, Chris Bailey-Kellogg, Karl E Griswold
Therapeutic proteins of wide-ranging function hold great promise for treating disease, but immune surveillance of these macromolecules can drive an antidrug immune response that compromises efficacy and even undermines safety. To eliminate widespread T-cell epitopes in any biotherapeutic and thereby mitigate this key source of detrimental immune recognition, we developed a Pareto optimal deimmunization library design algorithm that optimizes protein libraries to account for the simultaneous effects of combinations of mutations on both molecular function and epitope content...
June 12, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/28599289/enhanced-antiproliferative-activity-of-antibody-functionalized-polymeric-nanoparticles-for-targeted-delivery-of-anti-mir-21-to-her2-positive-gastric-cancer
#6
Feng-Lei Wu, Jian Zhang, Wei Li, Bao-Xiang Bian, Yi-Dong Hong, Zi-Yan Song, Hui-Yu Wang, Fang-Bo Cui, Ru-Tian Li, Qin Liu, Xiao-Dong Jiang, Xiao-Min Li, Jun-Nian Zheng
MiR-21 is an oncogenic miR frequently elevated in gastric cancer. Overexpression of miR-21 decreases the sensitivity of gastric cancer cells to trastuzumab, which is a humanized monoclonal antibody targeting human epidermal growth factor receptor 2. However, optimization of miRNA or its anti-miRNA oligonucleotides (AMOs) for delivery is a challenge. Receptor-mediated endocytosis plays a crucial role in the delivery of biotherapeutics including AMOs. This study is a continuation of our earlier findings involving poly(ε-caprolactone) (PCL)-poly (ethylene glycol) (PEG) nanoparticles (PEG-PCL NPs), which were coated with trastuzumab to target gastric cancer cells with HER2 receptor over-expression using anti-miRNA-21 antisense oligonucleotides (AMO-21)...
May 22, 2017: Oncotarget
https://www.readbyqxmd.com/read/28556621/measuring-the-aggregation-of-cho-cells-prior-to-single-cell-cloning-allows-a-more-accurate-determination-of-the-probability-of-clonality
#7
Kerensa J Klottrup, Guillermo Miro-Quesada, Layla Flack, Ivan Pereda, Pamela Hawley-Nelson
The manufacturing process for biotherapeutics is closely regulated by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory agencies worldwide. To ensure consistency of the product of a manufacturing cell line, International Committee on Harmonization guidelines (Q5D, 1997) state that the cell substrate should be derived from a single cell progenitor, i.e., clonal.Cell lines in suspension culture may naturally revert to cell adhesion in the form of doublets, triplets and higher order structures of clustered cells...
May 27, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/28556575/characterizing-the-impact-of-pressure-on-virus-filtration-processes-and-establishing-design-spaces-to-ensure-effective-parvovirus-removal
#8
Daniel Strauss, Joshua Goldstein, Tomoko Hongo-Hirasaki, Yoshiro Yokoyama, Naokatsu Hirotomi, Tomoyuki Miyabayashi, Dominick Vacante
Virus filtration provides robust removal of potential viral contaminants and is a critical step during the manufacture of biotherapeutic products. However, recent studies have shown that small virus removal can be impacted by low operating pressure and depressurization. To better understand the impact of these conditions and to define robust virus filtration design spaces, we conducted multivariate analyses to evaluate parvovirus removal over wide ranges of operating pressure, solution pH, and conductivity for three mAb products on Planova™ BioEX and 20N filters...
May 27, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/28541681/platelet-microcapsule-hybrids-leverage-contractile-force-for-targeted-delivery-of-hemostatic-agents
#9
Caroline E Hansen, David R Myers, W Hunter Baldwin, Yumiko Sakurai, Shannon L Meeks, L Andrew Lyon, Wilbur A Lam
We report a cell-mediated, targeted drug delivery system utilizing polyelectrolyte multilayer capsules that hybridize with the patient's own platelets upon intravenous administration. The hybridized platelets function as the sensor and actuator for targeted drug delivery and controlled release in our system. These capsules are biochemically and mechanically tuned to enable platelet adhesion and capsule rupture upon platelet activation and contraction, enabling the targeted and controlled "burst" release of an encapsulated biotherapeutic...
June 5, 2017: ACS Nano
https://www.readbyqxmd.com/read/28539564/improvement-of-local-cell-delivery-using-helix-transendocardial-delivery-catheter-in-a-porcine-heart
#10
Yoshiaki Mitsutake, Wook Bum Pyun, Didier Rouy, Cheryl Wong Po Foo, Simon H Stertzer, Peter Altman, Fumiaki Ikeno
Cardiac regeneration strategies using stem cells have shown variable and inconsistent results with respect to patient cardiac function and clinical outcomes. There has been increasing consensus that improving the efficiency of delivery may improve results. The Helix transendocardial delivery system (BioCardia Inc.) has been developed to enable percutaneous transendocardial biotherapeutic delivery. Therefore, we evaluated cell retention using this unique system compared with direct transepicardial injection and intracoronary infusion in an animal model...
May 23, 2017: International Heart Journal
https://www.readbyqxmd.com/read/28536452/exploring-the-trails-less-travelled-trail-in-cancer-biology-and-therapy
#11
REVIEW
Silvia von Karstedt, Antonella Montinaro, Henning Walczak
The discovery that the tumour necrosis factor-related apoptosis-inducing ligand (TRAIL) can induce apoptosis of cancer cells without causing toxicity in mice has led to the in-depth study of pro-apoptotic TRAIL receptor (TRAIL-R) signalling and the development of biotherapeutic drug candidates that activate TRAIL-Rs. The outcome of clinical trials with these TRAIL-R agonists has, however, been disappointing so far. Recent evidence indicates that many cancers, in addition to being TRAIL resistant, use the endogenous TRAIL-TRAIL-R system to their own advantage...
May 24, 2017: Nature Reviews. Cancer
https://www.readbyqxmd.com/read/28528575/characterization-of-a-cyclic-olefin-polymer-microcentrifuge-tube
#12
Lloyd Waxman, Rachel L Erwin, Vinod D Vilivalam
Here, we describe the properties of a prototype microcentrifuge tube made from the plastic cyclic olefin polymer (COP). This material has been used in the manufacture of primary containers including syringes and vials for the storage, shipment, and delivery of biotherapeutics, vaccines, and cell therapy products. Its low level of extractable substances and metals along with its glass-like clarity make COP an attractive material for the fabrication of microcentrifuge tubes and other consumable laboratory plasticware where contamination is an important consideration, such as in the storage and analysis of labile proteins, nucleic acids, and metabolites...
May 1, 2017: BioTechniques
https://www.readbyqxmd.com/read/28526733/discovery-and-optimization-of-hkt288-a-cadherin-6-targeting-adc-for-the-treatment-of-ovarian-and-renal-cancer
#13
Carl U Bialucha, Scott D Collins, Xiao Li, Parmita Saxena, Xiamei Zhang, Clemens Dürr, Bruno LaFont, Pierric Prieur, Yeonju Shim, Rebecca Mosher, David Lee, Lance Ostrom, Tiancen Hu, Sanela Bilic, Ivana Liric Rajlic, Vladimir Capka, Wei Jiang, Joel P Wagner, GiNell Elliott, Artur Veloso, Jessica C Piel, Meghan M Flaherty, Keith G Mansfield, Emily K Meseck, Tina Rubic-Schneider, Anne Serdakowski London, William R Tschantz, Markus Kurz, Duc Nguyen, Aaron Bourret, Matthew J Meyer, Jason E Faris, Mary J Janatpour, Vivien W Chan, Nicholas C Yoder, Kalli C Catcott, Molly A McShea, Xiuxia Sun, Hui Gao, Juliet Williams, Francesco Hofmann, Jeffrey A Engelman, Seth A Ettenberg, William R Sellers, Emma Lees
Despite an improving therapeutic landscape, significant challenges remain in treating the majority of advanced ovarian and renal cancer patients. We identified the cell-cell adhesion molecule cadherin-6 (CDH6) as a lineage gene having significant differential expression in ovarian and kidney cancer. HKT288 is an optimized CDH6-targeting DM4-based antibody drug conjugate (ADC) developed for the treatment of these diseases. Our study provides mechanistic evidence supporting the importance of linker choice for optimal anti-tumor activity and highlights CDH6 as a novel antigen for biotherapeutic development...
May 19, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28526278/biotherapeutics-in-chronic-rhinosinusitis-with-and-without-nasal-polyps
#14
Claus Bachert, Philippe Gevaert, Peter Hellings
In western countries, 85% of chronic rhinosinusitis with nasal polyp disease reveals a type 2 inflammatory pattern with expression of IL-4, -5, and -13 as well as increased concentrations of IgE, whereas chronic rhinosinusitis without nasal polyps merely expresses these biomarkers. The degree of type 2 inflammation furthermore is associated with disease severity, asthma comorbidity, and recurrence of disease after surgery. Therefore, these biomarkers also form the targets for innovative therapeutic approaches such as monoclonal antibodies directed against IgE, IL-5, and IL-4 receptor alpha, blocking the activity of IL-4 and -13...
May 16, 2017: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/28509534/analysis-of-three-epoetin-alpha-products-by-lc-and-lc-ms-indicates-differences-in-glycosylation-critical-quality-attributes-including-sialic-acid-content
#15
Rebecca I Thomson, Richard A Gardner, Katja Strohfeldt, Daryl L Fernandes, Graham P Stafford, Daniel I R Spencer, Helen M I Osborn
Erythropoietin (EPO) is one of the main therapeutics used to treat anemic patients, greatly improving their quality of life. In this study, biosimilars Binocrit and a development product, called here CIGB-EPO, were compared to the originator product, Eprex. All three are epoetin alpha products, reputed to have similar glycosylation profiles. The quality, safety, and efficacy of this biotherapeutic depend on the following glycosylation critical quality attributes (GCQAs): sialylation, N-glycolyl-neuraminic acid (Neu5Gc) content, branching, N-acetyl-lactosamine (LacNAc) extensions, and O-acetylation pattern...
June 9, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28493135/characterization-of-host-cell-proteins-hcps-in-cho-cell-bioprocesses
#16
Catherine E M Hogwood, Lesley M Chiverton, C Mark Smales
Host cell protein content during bioprocessing of biotherapeutic proteins generated from cultured Chinese hamster ovary (CHO) cells is typically measured using immunological and gel-based methods. Estimation of HCP concentration is usually undertaken using Enzyme-Linked ImmunoSorbent Assays (ELISA), while estimation of HCP clearance/presence can be achieved by comparing 2D-PAGE images of samples and by undertaking western blotting of 2D-PAGE analyzed samples. Here, we describe the analyses of HCP content using these methodologies...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28493121/glycoengineering-of-cho-cells-to-improve-product-quality
#17
Qiong Wang, Bojiao Yin, Cheng-Yu Chung, Michael J Betenbaugh
Chinese hamster ovary (CHO) cells represent the predominant platform in biopharmaceutical industry for the production of recombinant biotherapeutic proteins, especially glycoproteins. These glycoproteins include oligosaccharide or glycan attachments that represent one of the principal components dictating product quality. Especially important are the N-glycan attachments present on many recombinant glycoproteins of commercial interest. Furthermore, altering the glycan composition can be used to modulate the production quality of a recombinant biotherapeutic from CHO and other mammalian hosts...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28488883/ultrasensitive-bioanalysis-current-status-and-future-trends
#18
Stéphanie Simon, Eric Ezan
Ligand-binding techniques such as immunoassays, the reference for clinical diagnosis, offer a wide range of innovative approaches based on signal DNA amplification, nanotechnologies or digital assays, which result in technologies with sensitivities more than 1000-times that of formats used 20 years ago. Providing that these technologies gain acceptance and translate into robust commercial platforms, we expect that several fields will be impacted in the near future, including the clinical diagnosis of cancer markers, the early detection of infectious diseases and the safety of biotherapeutics...
May 2017: Bioanalysis
https://www.readbyqxmd.com/read/28488174/characterization-of-apolipoprotein-c3-apo-c3-lna-dna-impurities-and-degradation-products-by-lc-ms-ms
#19
Olga V Friese, Justin B Sperry, Yan He, Liji Joseph, James A Carroll, Jason C Rouse
Apolipoprotein C3 (Apo C3) LNA/DNA gapmer was evaluated under various stress and formulation conditions for the purpose of its development as a potential biotherapeutic for low density lipoprotein (LDL) lowering. Using ion-pairing (IP) reversed-phase (RP) liquid chromatography ultra-high resolution (UHR) tandem mass spectrometry (IP-RPLC-MS/MS), a combination of accurate mass measurements and collision-induced dissociation enabled in-depth characterization of Apo C3 LNA/DNA oligonucleotide, in particular the inherent impurities following synthesis and degradation products after exposure to stress conditions...
May 9, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28486471/model-based-analysis-of-n-glycosylation-in-chinese-hamster-ovary-cells
#20
Frederick J Krambeck, Sandra V Bennun, Mikael R Andersen, Michael J Betenbaugh
The Chinese hamster ovary (CHO) cell is the gold standard for manufacturing of glycosylated recombinant proteins for production of biotherapeutics. The similarity of its glycosylation patterns to the human versions enable the products of this cell line favorable pharmacokinetic properties and lower likelihood of causing immunogenic responses. Because glycan structures are the product of the concerted action of intracellular enzymes, it is difficult to predict a priori how the effects of genetic manipulations alter glycan structures of cells and therapeutic properties...
2017: PloS One
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