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https://www.readbyqxmd.com/read/28070711/immune-suppression-during-preclinical-drug-development-mitigates-immunogenicity-mediated-impact-on-therapeutic-exposure
#1
Jonathan Herskovitz, Josiah Ryman, Theingi Thway, Stephanie Lee, Lei Zhou, Narendra Chirmule, Bernd Meibohm, Vibha Jawa
In the clinical setting, anti-drug antibodies (ADA) against biotherapeutics can influence patient safety and interfere with product efficacy. High immunogenicity has been addressed in clinic by concomitant immune suppression, such as co-administration of methotrexate with enzyme replacement therapy (ERT) and combination tacrolimus/sirolimus treatment for prophylaxis against organ transplant rejection. This study investigates the use of such immune suppressants in mitigating ADA responses to a fully human monoclonal antibody (mAb1) in preclinical animal studies...
January 9, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28050869/the-separation-and-quantitation-of-peptides-with-and-without-oxidation-of-methionine-and-deamidation-of-asparagine-using-hydrophilic-interaction-liquid-chromatography-with-mass-spectrometry-hilic-ms
#2
Majors J Badgett, Barry Boyes, Ron Orlando
Peptides with deamidated asparagine residues and oxidized methionine residues are often not resolved sufficiently to allow quantitation of their native and modified forms using reversed phase (RP) chromatography. The accurate quantitation of these modifications is vital in protein biotherapeutic analysis because they can affect a protein's function, activity, and stability. We demonstrate here that hydrophilic interaction liquid chromatography (HILIC) adequately and predictably separates peptides with these modifications from their native counterparts...
January 3, 2017: Journal of the American Society for Mass Spectrometry
https://www.readbyqxmd.com/read/28024544/design-of-starch-formate-compound-fibers-as-encapsulation-platform-for-biotherapeutics
#3
Anica Lancuški, Aiman Abu Ammar, Ron Avrahami, Rita Vilensky, Gleb Vasilyev, Eyal Zussman
Effective encapsulation and protection of biotherapeutics using a bio-based carrier, preferably issued from renewable resources, remains a challenge. Herein, we demonstrate application of coaxial electrospinning to fabric starch-based core-sheath compound fibers as a bacterial cells' carrier. Starch-formate is employed as an encapsulation agent, while the fiber core is made of glycerol, serving as a cell suspension medium. SEM microscopy reveals a distinct core-sheath morphology of the starch-formate/glycerol (SFG) compound fibers with mean diameters of 4...
February 20, 2017: Carbohydrate Polymers
https://www.readbyqxmd.com/read/28017888/nanogels-for-intracellular-delivery-of-biotherapeutics
#4
Dandan Li, Cornelus F van Nostrum, Enrico Mastrobattista, Tina Vermonden, Wim E Hennink
Many biomolecules, such as proteins and genes, are presently used as therapeutics. However, their delivery to target sites inside cells is challenging because of their large molecular size, difficulties to pass cellular membranes and their susceptibility for enzymatic and chemical degradation. Nanogels, three-dimensional networks of hydrophilic polymers, are attractive carrier systems for these biotherapeutics because they protect the biologicals against degradation and, importantly, facilitate cell internalization...
December 23, 2016: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/28004147/developing-anti-neoplastic-biotherapeutics-against-eif4f
#5
REVIEW
Jutta Steinberger, Jennifer Chu, Rayelle Itoua Maïga, Katia Sleiman, Jerry Pelletier
Biotherapeutics have revolutionized modern medicine by providing medicines that would not have been possible with small molecules. With respect to cancer therapies, this represents the current sector of the pharmaceutical industry having the largest therapeutic impact, as exemplified by the development of recombinant antibodies and cell-based therapies. In cancer, one of the most common regulatory alterations is the perturbation of translational control. Among these, changes in eukaryotic initiation factor 4F (eIF4F) are associated with tumor initiation, progression, and drug resistance in a number of settings...
December 21, 2016: Cellular and Molecular Life Sciences: CMLS
https://www.readbyqxmd.com/read/27999526/cme-cne-article-a-framework-of-care-in-multiple-sclerosis-part-1-updated-disease-classification-and-disease-modifying-therapy-use-in-specific-circumstances
#6
Scott D Newsome, Philip J Aliotta, Jacquelyn Bainbridge, Susan E Bennett, Gary Cutter, Kaylan Fenton, Fred Lublin, Dorothy Northrop, David Rintell, Bryan D Walker, Megan Weigel, Kathleen Zackowski, David E Jones
: Activity Available Online: To access the article, post-test, and evaluation online, go to http://www.cmscscholar.org. TARGET AUDIENCE: The target audience for this activity is physicians, physician assistants, nursing professionals, and other health-care providers involved in the management of patients with multiple sclerosis (MS). LEARNING OBJECTIVES: Apply new information about MS to a comprehensive individualized treatment plan for patients with MSIntegrate the team approach into long-term planning in order to optimize rehabilitation care of patients with MSAccreditation Statement: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Consortium of Multiple Sclerosis Centers (CMSC), Nurse Practitioner Alternatives (NPA), and Delaware Media Group...
November 2016: International Journal of MS Care
https://www.readbyqxmd.com/read/27984091/the-bacillus-subtilis-tatadcd-system-exhibits-an-extreme-level-of-substrate-selectivity
#7
Kelly M Frain, Alexander S Jones, Ronald Schoner, Kelly L Walker, Colin Robinson
The Tat system preferentially transports correctly folded proteins across the bacterial membrane although little is known of the proofreading mechanism. Most research has focused on TatABC systems from Gram-negative bacteria, especially Escherichia coli, and much less is known of the TatAC-type systems from Gram-positive organisms. We have previously shown that the Bacillus subtilis TatAdCd system is functional in an E. coli tat null background and able to transport TorA-GFP and native TorA (TMAO reductase); here, we examined its ability to transport other proteins bearing a TorA signal sequence...
October 29, 2016: Biochimica et Biophysica Acta
https://www.readbyqxmd.com/read/27977915/transient-and-stable-cho-expression-purification-and-characterization-of-novel-hetero-dimeric-bispecific-igg-antibodies
#8
Yashas Rajendra, Robert B Peery, Maria D Hougland, Xiufeng Wu, Jonathan R Fitchett, Michael Bacica, Stephen J Demarest, Gavin C Barnard
IgG bispecific antibodies (BsAbs) represent one of the preferred formats for bispecific antibody therapeutics due to their native-like IgG properties and their monovalent binding to each target. Most reported studies utilized transient expression in HEK293 cells to produce BsAbs. However, the expression of biotherapeutic molecules using stable CHO cell lines is commonly used for biopharmaceutical manufacturing. Unfortunately, limited information is available in the scientific literature on the expression of BsAbs in CHO cell lines...
December 15, 2016: Biotechnology Progress
https://www.readbyqxmd.com/read/27977908/integrated-continuous-processing-of-proteins-expressed-as-inclusion-bodies-gcsf-as-a-case-study
#9
Nikhil Kateja, Harshit Agarwal, Vishwanath Hebbi, Anurag S Rathore
Affordability of biopharmaceuticals continues to be a challenge, particularly in developing economies. This has fuelled advancements in manufacturing that can offer higher productivity and better economics without sacrificing product quality in the form of an integrated continuous manufacturing platform. While platform processes for monoclonal antibodies have existed for more than a decade, development of an integrated continuous manufacturing process for bacterial proteins has received relatively scant attention...
December 15, 2016: Biotechnology Progress
https://www.readbyqxmd.com/read/27929101/hookworm-infection
#10
Alex Loukas, Peter J Hotez, David Diemert, Maria Yazdanbakhsh, James S McCarthy, Rodrigo Correa-Oliveira, John Croese, Jeffrey M Bethony
Hookworms are soil-transmitted nematode parasites that can reside for many years in the small intestine of their human hosts; Necator americanus is the predominant infecting species. Adult worms feed on the blood of a host and can cause iron deficiency anaemia, especially in high-risk populations (children and women of childbearing age). Almost 500 million people in developing tropical countries are infected, and simulation models estimate that hookworm infection is responsible for >4 million disability-adjusted life years lost annually...
December 8, 2016: Nature Reviews. Disease Primers
https://www.readbyqxmd.com/read/27928884/building-proteomic-tool-boxes-to-monitor-mhc-class-i-and-class-ii-peptides
#11
REVIEW
Frances-Rose Schumacher, Lélia Delamarre, Suchit Jhunjhunwala, Zora Modrusan, Qui T Phung, Joshua E Elias, Jennie R Lill
Major histocompatibility complex Class I (MHCI) and Class II (MHCII) presented peptides powerfully modulate T cell immunity and play a vital role in generating effective anti-tumor and anti-viral immune responses in mammals. Characterizing these MHCI or MHCII presented peptides can help generate therapeutic treatments, afford information on T cell mediated biomarkers, provide insight into disease progression, and reduce adverse anti-drug side effects from engineered biotherapeutics. Here, we explore the tools and techniques commonly employed to discover both MHCI and MHCII presented peptides...
December 8, 2016: Proteomics
https://www.readbyqxmd.com/read/27919942/a-single-intravesical-instillation-of-vax014-inhibits-orthotopic-superficial-bladder-tumor-implantation-to-increase-survival
#12
Bryan M Hancock, Kathleen L McGuire, Shingo Tsuji, Katherine Reil, Veronica Hernandez, Matthew J Giacalone, W T Godbey
BACKGROUND/AIM: VAX014 minicells (VAX014) have been previously characterized as an integrin-specific oncolytic biotherapeutic agent. The present study was designed to evaluate the potential of VAX014 as an immediate post-operative intravesical adjuvant therapy in the treatment of non-muscle invasive bladder cancer (NMIBC). MATERIALS AND METHODS: The ability of VAX014 to kill a panel of dissociated urothelial carcinoma cell lines was tested in vitro. In vivo experiments were conducted using a single intravesical dose of VAX014 in the anti-implantation variation of the MB49 syngeneic orthotopic bladder cancer model with tumor implantation and overall survival rates serving as study endpoints...
2016: Anticancer Research
https://www.readbyqxmd.com/read/27914888/the-first-report-on-transcriptome-analysis-of-the-venom-gland-of-iranian-scorpion-hemiscorpius-lepturus
#13
Fatemeh Kazemi-Lomedasht, Vahid Khalaj, Kamran Pooshang Bagheri, Mahdi Behdani, Delavar Shahbazzadeh
Hemiscorpius lepturus scorpion is one of the most venomous members of the Hemiscorpiidae family. H. lepturus is distributed in Iran, Iraq and Yemen. The prevalence and severity of scorpionism is high and health services are not able to control it. Scorpionism in Iran especially in the southern regions (Khuzestan, Sistan and Baluchestan, Hormozgan, Ilam) is one of the main health challenges. Due to the medical and health importance of scorpionism, the focus of various studies has been on the identification of H...
January 2017: Toxicon: Official Journal of the International Society on Toxinology
https://www.readbyqxmd.com/read/27903090/pediococcus-acidilactici-lab4-and-lactobacillus-plantarum-lab12-assimilate-cholesterol-and-modulate-abca1-cd36-npc1l1-and-scarb1-in-vitro
#14
F T Lim, S M Lim, K Ramasamy
There is growing interest in the use of probiotic lactic acid bacteria (LAB) for prevention of hypercholesterolaemia. This study assessed the cholesterol lowering ability of Pediococcus acidilactici LAB4 and Lactobacillus plantarum LAB12 in growth media. Both LAB yielded >98% (39.2 μg/ml) cholesterol lowering in growth media. Nile Red staining indicated direct assimilation of cholesterol by the LAB. The LAB were then explored for their prophylactic (pre-treatment of HT29 cells with LAB prior to cholesterol exposure) and biotherapeutic (treatment of HT29 cells with LAB after exposure to cholesterol) use against short and prolonged exposure of HT29 cells to cholesterol, respectively...
December 1, 2016: Beneficial Microbes
https://www.readbyqxmd.com/read/27902414/modulation-of-intestinal-barrier-function-to-ameliorate-salmonella-infection-in-mice-by-oral-administration-of-fermented-milks-produced-with-lactobacillus-plantarum-mtcc-5690-a-probiotic-strain-of-indian-gut-origin
#15
Namita Rokana, Rajbir Singh, Rashmi Hogarehalli Mallappa, Virender Kumar Batish, Sunita Grover
Probiotic Lactobacillus plantarum MTCC 5690, a probiotic strain of Indian gut origin, and milk formulations produced with the same were explored in this study as biotherapeutics by evaluating their functional efficacy against Salmonella infection in mice. The efficacy of milk formulations (fermented/unfermented) of MTCC 5690 for enhancement of intestinal barrier function was determined by monitoring the permeability and histopathology of the intestine. Infected mice fed with probiotic Dahi, fermented probiotic drink and sweetened fermented probiotic drink maintained the health and integrity of the intestinal epithelium as compared to those fed with PBS, milk, unfermented probiotic milk and Dahi...
December 2016: Journal of Medical Microbiology
https://www.readbyqxmd.com/read/27895507/fc-gamma-receptors-glycobiology-and-therapeutic-prospects
#16
REVIEW
Jerrard M Hayes, Mark R Wormald, Pauline M Rudd, Gavin P Davey
Therapeutic antibodies hold great promise for the treatment of cancer and autoimmune diseases, and developments in antibody-drug conjugates and bispecific antibodies continue to enhance treatment options for patients. Immunoglobulin (Ig) G antibodies are proteins with complex modifications, which have a significant impact on their function. The most important of these modifications is glycosylation, the addition of conserved glycans to the antibody Fc region, which is critical for its interaction with the immune system and induction of effector activities such as antibody-dependent cell cytotoxicity, complement activation and phagocytosis...
2016: Journal of Inflammation Research
https://www.readbyqxmd.com/read/27884078/a-semi-universal-assay-platform-to-quantitate-vaccines-with-potential-applications-for-biotherapeutics
#17
Jeanette Roman, Silikhone Bouaraphan, Thorsten Verch
AIM: Biologics development often requires multiple immunoassays to evaluate both assay reagents and potential drug candidates resulting in extensive analytical development. METHODOLOGY: We developed a semi-universal, 5-layer platform assay on Gyrolab using secondary antispecies or anti-isotype-specific capture and detection antibodies. We applied the assay to several multivalent vaccines. RESULTS: Method performance exhibited a median accuracy of 110%, reproducibility of 9% CV and intermediate precision of 11% CV...
December 2016: Bioanalysis
https://www.readbyqxmd.com/read/27883890/a-consensus-genome-scale-reconstruction-of-chinese-hamster-ovary-cell-metabolism
#18
Hooman Hefzi, Kok Siong Ang, Michael Hanscho, Aarash Bordbar, David Ruckerbauer, Meiyappan Lakshmanan, Camila A Orellana, Deniz Baycin-Hizal, Yingxiang Huang, Daniel Ley, Veronica S Martinez, Sarantos Kyriakopoulos, Natalia E Jiménez, Daniel C Zielinski, Lake-Ee Quek, Tune Wulff, Johnny Arnsdorf, Shangzhong Li, Jae Seong Lee, Giuseppe Paglia, Nicolas Loira, Philipp N Spahn, Lasse E Pedersen, Jahir M Gutierrez, Zachary A King, Anne Mathilde Lund, Harish Nagarajan, Alex Thomas, Alyaa M Abdel-Haleem, Juergen Zanghellini, Helene F Kildegaard, Bjørn G Voldborg, Ziomara P Gerdtzen, Michael J Betenbaugh, Bernhard O Palsson, Mikael R Andersen, Lars K Nielsen, Nicole Borth, Dong-Yup Lee, Nathan E Lewis
Chinese hamster ovary (CHO) cells dominate biotherapeutic protein production and are widely used in mammalian cell line engineering research. To elucidate metabolic bottlenecks in protein production and to guide cell engineering and bioprocess optimization, we reconstructed the metabolic pathways in CHO and associated them with >1,700 genes in the Cricetulus griseus genome. The genome-scale metabolic model based on this reconstruction, iCHO1766, and cell-line-specific models for CHO-K1, CHO-S, and CHO-DG44 cells provide the biochemical basis of growth and recombinant protein production...
November 23, 2016: Cell Systems
https://www.readbyqxmd.com/read/27879056/in-vitro-drug-and-gene-delivery-using-random-cationic-copolymers-forming-stable-and-ph-sensitive-polymersomes
#19
Partha Laskar, Joykrishna Dey, Payel Banik, Mahitosh Mandal, Sudip Kumar Ghosh
Stimuli-sensitive polymeric vesicles or polymersomes as self-assembled colloidal nanocarriers have received paramount importance for their integral role as delivery system for therapeutics and biotherapeutics. This work describes spontaneous polymersome formation at pH 7, as evidenced by surface tension, steady state fluorescence, dynamic light scattering, and microscopic studies, by three hydrophilic random cationic copolymers synthesized using N,N-(dimethylamino)ethyl methacrylate (DMAEM) and methoxy poly(ethylene glycol) monomethacrylate in different mole ratios...
November 23, 2016: Macromolecular Bioscience
https://www.readbyqxmd.com/read/27877247/beyond-the-barriers-of-light-penetration-strategies-perspectives-and-possibilities-for-photodynamic-therapy
#20
REVIEW
Srivalleesha Mallidi, Sriram Anbil, Anne-Laure Bulin, Girgis Obaid, Megumi Ichikawa, Tayyaba Hasan
Photodynamic therapy (PDT) is a photochemistry based treatment modality that involves the generation of cytotoxic species through the interactions of a photosensitizer molecule with light irradiation of an appropriate wavelength. PDT is an approved therapeutic modality for several cancers globally and in several cases has proved to be effective where traditional treatments have failed. The key parameters that determine PDT efficacy are 1. the photosensitizer (nature of the molecules, selectivity, and macroscopic and microscopic localization etc...
2016: Theranostics
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