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https://www.readbyqxmd.com/read/29337293/a-teem-sup-tm-sup-a-new-molecular-fingerprinting-technique-simultaneous-absorbance-transmission-and-fluorescence-excitation-emission-matrix-method
#1
Alessia Quatela, Adam Gilmore, Karen E Steege Gall, Marinella Sandros, Karoly Csatorday, Alex Siemiarczuk, Boqian Ben Yang, Loïc Camenen
We investigate the new simultaneous Absorbance-Transmission and fluorescence Excitation-Emission Matrix method for rapid and effective characterization of the varying components from a mixture. The Absorbance-Transmission and fluorescence Excitation-Emission Matrix method uniquely facilitates correction of fluorescence inner-filter effects to yield quantitative fluorescence spectral information that is largely independent of component concentration. This is significant because it allows one to effectively monitor quantitative component changes using multivariate methods and to generate and evaluate spectral libraries...
January 16, 2018: Methods and Applications in Fluorescence
https://www.readbyqxmd.com/read/29337201/on-the-glycosylation-aspects-of-biosimilarity
#2
REVIEW
László Hajba, Ákos Szekrényes, Beáta Borza, András Guttman
The recent expiration of several protein therapeutics opened the door for biosimilar development. Biosimilars are biologic medical products that are similar but not identical copies of already-authorized protein therapeutics. Critical quality attributes (CQA), such as post-translational modifications of recombinant biotherapeutics, are important for the clinical efficacy and safety of both the innovative biologics and their biosimilar counterparts. Here, we summarize biosimilarity CQAs, considering the regulatory guidelines and the statistical aspects (e...
January 11, 2018: Drug Discovery Today
https://www.readbyqxmd.com/read/29336981/challenges-and-opportunities-for-the-subcutaneous-delivery-of-therapeutic-proteins
#3
REVIEW
Michael R Turner, Sathy V Balu-Iyer
Biotherapeutics are a rapidly growing drug class and well over 200 biotherapeutics have already obtained approval, with about fifty of these being approved in 2015 and 2016 alone 1. Several hundred protein therapeutic products are still in the pipeline, including interesting new approaches to treatment. Due to patients' convenience of at home administration and reduced number of hospital visits as well as the reduction in treatment costs, subcutaneous (SC) administration of biologics is of increasing interest...
January 11, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29329709/characterization-of-singly-and-multiply-pegylated-insulin-isomers-by-reversed-phase-ultra-performance-liquid-chromatography-interfaced-with-ion-mobility-mass-spectrometry
#4
Selim Gerislioglu, Scott R Adams, Chrys Wesdemiotis
Conjugation of poly(ethylene glycol) (PEG) to protein drugs (PEGylation) is increasingly utilized in the biotherapeutics field because it improves significantly the drugs' circulatory half-life, solubility, and shelf-life. The activity of a PEGylated drug depends on the number, size, and location of the attached PEG chain(s). This study introduces a 2D separation approach, including reversed-phase ultra-performance liquid chromatography (RP-UPLC) and ion mobility mass spectrometry (IM-MS), in order to determine the structural properties of the conjugates, as demonstrated for a PEGylated insulin sample that was prepared by random amine PEGylation...
April 3, 2018: Analytica Chimica Acta
https://www.readbyqxmd.com/read/29315258/methods-for-using-small-non-coding-rnas-to-improve-recombinant-protein-expression-in-mammalian-cells
#5
REVIEW
Sarah Inwood, Michael J Betenbaugh, Joseph Shiloach
The ability to produce recombinant proteins by utilizing different "cell factories" revolutionized the biotherapeutic and pharmaceutical industry. Chinese hamster ovary (CHO) cells are the dominant industrial producer, especially for antibodies. Human embryonic kidney cells (HEK), while not being as widely used as CHO cells, are used where CHO cells are unable to meet the needs for expression, such as growth factors. Therefore, improving recombinant protein expression from mammalian cells is a priority, and continuing effort is being devoted to this topic...
January 9, 2018: Genes
https://www.readbyqxmd.com/read/29296951/t-cell-assays-confirm-immunogenicity-of-tungsten-induced-erythropoietin-aggregates-associated-with-pure-red-cell-aplasia
#6
Tina Rubic-Schneider, Masataka Kuwana, Brigitte Christen, Manuela Aßenmacher, Otmar Hainzl, Frank Zimmermann, Robert Fischer, Vera Koppenburg, Salah-Dine Chibout, Timothy M Wright, Andreas Seidl, Michael Kammüller
Immunogenicity of biotherapeutics and the elicitation of anti-drug antibodies are a key concern for their efficacy, pharmacokinetics, and safety. A particularly severe consequence of immunogenicity of a biotherapeutic is the rare development of antibody-mediated pure red cell aplasia (PRCA) in anemic patients treated with aggregated forms of recombinant human erythropoietin (rhEPO). Here, we investigated in vitro T-cell responses to experimentally heat-induced rhEPO aggregates, and to tungsten-induced rhEPO aggregates in clinical lots associated with rhEPO-neutralizing antibodies and PRCA...
February 14, 2017: Blood Advances
https://www.readbyqxmd.com/read/29296786/icam-1-targeted-thrombomodulin-mitigates-tissue-factor-driven-inflammatory-thrombosis-in-a-human-endothelialized-microfluidic-model
#7
Colin F Greineder, Ian H Johnston, Carlos H Villa, Kandace Gollomp, Charles T Esmon, Douglas B Cines, Mortimer Poncz, Vladimir R Muzykantov
Diverse human illnesses are characterized by loss or inactivation of endothelial thrombomodulin (TM), predisposing to microvascular inflammation, activation of coagulation, and tissue ischemia. Single-chain antibody fragment (scFv)/TM) fusion proteins, previously protective against end-organ injury in murine models of inflammation, are attractive candidates to treat inflammatory thrombosis. However, animal models have inherent differences in TM and coagulation biology, are limited in their ability to resolve and control endothelial biology, and do not allow in-depth testing of "humanized" scFv/TM fusion proteins, which are necessary for translation to the clinical domain...
August 8, 2017: Blood Advances
https://www.readbyqxmd.com/read/29290153/the-role-of-heparan-sulfate-in-inflammation-and-the-development-of-biomimetics-as-anti-inflammatory-strategies
#8
Brooke L Farrugia, Megan S Lord, James Melrose, John M Whitelock
Key events that occur during inflammation include the recruitment, adhesion, and transmigration of leukocytes from the circulation to the site of inflammation. These events are modulated by chemokines, integrins, and selectins and the interaction of these molecules with glycosaminoglycans, predominantly heparan sulfate (HS). The development of HS/heparin mimetics that interfere or inhibit the interactions that occur between glycosaminoglycans and modulators of inflammation holds great potential for use as anti-inflammatory therapeutics...
November 1, 2017: Journal of Histochemistry and Cytochemistry: Official Journal of the Histochemistry Society
https://www.readbyqxmd.com/read/29289489/meeting-report-who-informal-consultation-on-development-of-guidelines-on-procedures-and-data-requirements-for-changes-to-approved-biotherapeutic-products-seoul-republic-of-korea-27-28-april-2017
#9
Meenu Wadhwa, Hye-Na Kang, Hugo Hamel, Teeranart Jivapaisarnpong
In April 2017, WHO convened an informal consultation to develop WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products. The objective of the meeting was to review the draft of WHO guidelines and the comments received from the public consultation. The guidelines were recognized by the participants as a tool for regulatory convergence and harmonization. Regulation of changes to approved biotherapeutic products is a key in ensuring that products of consistent quality, safety and efficacy are distributed after they receive authorization or licensure...
December 27, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29278727/application-of-cfd-in-bioprocessing-separation-of-mammalian-cells-using-disc-stack-centrifuge-during-production-of-biotherapeutics
#10
Lalita Kanwar Shekhawat, Jayati Sarkar, Rachit Gupta, Sandeep Hadpe, Anurag S Rathore
Centrifugation continues to be one of the most commonly used unit operations for achieving efficient harvest of the product from the mammalian cell culture broth during production of therapeutic monoclonal antibodies (mAbs). Since the mammalian cells are known to be shear sensitive, optimal performance of the centrifuge requires a balance between productivity and shear. In this study, Computational Fluid Dynamics (CFD) has been successfully used as a tool to facilitate efficient optimization. Multiphase Eulerian-Eulerian model coupled with Gidaspow drag model along with k-ε mixture turbulence model have been used to quantify the complex hydrodynamics of the centrifuge and thus evaluate the turbulent stresses generated by the centrifugal forces...
December 23, 2017: Journal of Biotechnology
https://www.readbyqxmd.com/read/29276835/a-sensitive-high-throughput-and-robust-trapping-micro-lc-ms-strategy-for-quantification-of-biomarkers-and-antibody-biotherapeutics
#11
Ming Zhang, Bo An, Yang Qu, Shichen Shen, Wei Fu, Yuan-Ju Chen, Xue Wang, Rebeccah Young, John M Canty, Joseph P Balthasar, Keeley Murphy, Debadeep Bhattacharyya, Jonathan L Josephs, Luca Ferrari, Shaolian Zhou, Surendra Bansal, Faye Vazvaei, Jun Qu
For LC-MS-based targeted quantification of biotherapeutics/biomarkers in clinical and pharmaceutical environments, high sensitivity, high throughput, and excellent robustness are all essential, but remain challenging. For example, though nano-LC-MS has been employed to enhance analytical sensitivity, it falls short due to its low loading capacity, poor throughput and low operational robustness. Furthermore, high chemical noise in protein bioanalysis typically limits the sensitivity. Here we describe a novel Trapping-micro-LC-MS (T-µLC-MS) strategy for targeted protein bioanalysis, achieving high sensitivity with exceptional robustness and high throughput...
December 25, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/29243301/evaluation-of-the-live-biotherapeutic-product-asymptomatic-bacteriuria-escherichia-coli-2-12-in-healthy-dogs-and-dogs-with-clinical-recurrent-uti
#12
G Segev, J E Sykes, D J Klumpp, A J Schaeffer, E M Antaki, B A Byrne, R E Yaggie, J L Westropp
BACKGROUND: Antimicrobial resistance is an emerging problem. HYPOTHESIS/OBJECTIVE: To investigate the safety and efficacy of a live biotherapeutic product, ASB E. coli 2-12 for UTI treatment. ANIMALS: Six healthy research dogs; nine client-owned dogs with recurrent UTI. METHODS: Prospective noncontrolled clinical trial. For safety data, research dogs were sedated, a urinary catheter was inserted into the bladder; 1010 CFU/mL of ASB E...
December 15, 2017: Journal of Veterinary Internal Medicine
https://www.readbyqxmd.com/read/29241186/strengthening-gastric-cancer-therapy-by-trastuzumab-conjugated-nanoparticles-with-simultaneous-encapsulation-of-anti-mir-21-and-5-fluorouridine
#13
Nan Hu, Jun Feng Yin, Ze Ji, Yidong Hong, Puyuan Wu, Baoxiang Bian, Ziyan Song, Rutian Li, Qin Liu, Fenglei Wu
BACKGROUND/AIMS: MicroRNA-21 is an oncogenic miR (oncomiR) frequently elevated in gastric cancer (GC). Overexpression of miR-21 decreases the sensitivity of GC cells to 5-fluorouridine (5-Fu) and trastuzumab, a humanized monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2). Receptor-mediated endocytosis plays a crucial role in the delivery of biotherapeutics including anti-miRNA oligonucleotides (AMOs). This study is a continuation of earlier findings involving poly(ε-caprolactone) (PCL)-poly (ethylene glycol) (PEG) nanoparticles (PEG-PCL NPs), which were coated with trastuzumab to target GC with HER2 receptor over-expression using anti-miRNA-21 (AMO-21) and 5-Fu...
December 12, 2017: Cellular Physiology and Biochemistry
https://www.readbyqxmd.com/read/29209322/camelid-single-domain-antibodies-historical-perspective-and-future-outlook
#14
Mehdi Arbabi-Ghahroudi
Tremendous effort has been expended over the past two and a half decades to understand many aspects of camelid heavy chain antibodies, from their biology, evolution, and immunogenetics to their potential applications in various fields of research and medicine. In this article, I present a historical perspective on the development of camelid single-domain antibodies (sdAbs or VHHs, also widely known as nanobodies) since their discovery and discuss the advantages and disadvantages of these unique molecules in various areas of research, industry, and medicine...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/29205415/systematic-review-human-gut-dysbiosis-induced-by-non-antibiotic-prescription-medications
#15
REVIEW
Q Le Bastard, G A Al-Ghalith, M Grégoire, G Chapelet, F Javaudin, E Dailly, E Batard, D Knights, E Montassier
BACKGROUND: Global prescription drug use has been increasing continuously for decades. The gut microbiome, a key contributor to health status, can be altered by prescription drug use, as antibiotics have been repeatedly described to have both short-term and long-standing effects on the intestinal microbiome. AIM: To summarise current findings on non-antibiotic prescription-induced gut microbiome changes, focusing on the most frequently prescribed therapeutic drug categories...
December 5, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29205064/2017-white-paper-on-recent-issues-in-bioanalysis-a-global-perspective-on-immunogenicity-guidelines-biomarker-assay-performance-part-3-lba-immunogenicity-biomarkers-and-pk-assays
#16
Shalini Gupta, Susan Richards, Lakshmi Amaravadi, Steven Piccoli, Binodh Desilva, Renuka Pillutla, Lauren Stevenson, Devangi Mehta, Montserrat Carrasco-Triguero, Robert Neely, Michael Partridge, Roland F Staack, Xuemei Zhao, Boris Gorovits, Gerry Kolaitis, Giane Sumner, Kay-Gunnar Stubenrauch, Linglong Zou, Shashi Amur, Chris Beaver, Isabella Berger, Flora Berisha, Herbert Birnboeck, Joe Bower, Seongeun Julia Cho, Isabelle Cludts, Laurent Cocea, Lorella Di Donato, Saloumeh Fischer, Stephanie Fraser, Fabio Garofolo, Sam Haidar, Jonathan Haulenbeek, Charles Hottenstein, Jenny Hu, Akiko Ishii-Watabe, Rafiq Islam, Darshana Jani, John Kadavil, John Kamerud, Daniel Kramer, Pekka Kurki, Stephen MacMannis, Jim McNally, Ashley Mullan, Apollon Papadimitriou, João Pedras-Vasconcelos, Soma Ray, Afshin Safavi, Yoshiro Saito, Natasha Savoie, Marianne Scheel Fjording, Kara Scheibner, John Smeraglia, An Song, Bruce Stouffer, Nilufer Tampal, Barry van der Strate, Thorsten Verch, Jan Welink, Yuanxin Xu, Tong-Yuan Yang, Lilian Yengi, Jianing Zeng, Yan Zhang, Yanhua Zhang, Stephen Zoog
The 2017 11th Workshop on Recent Issues in Bioanalysis took place in Los Angeles/Universal City, California, on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule analysis involving LC-MS, hybrid ligand-binding assay (LBA)/LC-MS and LBA approaches...
December 2017: Bioanalysis
https://www.readbyqxmd.com/read/29205053/2017-white-paper-rise-of-hybrid-lba-lcms-immunogenicity-assays-part-2-hybrid-lba-lcms-biotherapeutics-biomarkers-immunogenicity-assays-and-regulatory-agencies-inputs
#17
Hendrik Neubert, An Song, Anita Lee, Cong Wei, Jeff Duggan, Keyang Xu, Eric Woolf, Chris Evans, Joe Palandra, Omar Laterza, Shashi Amur, Isabella Berger, Mark Bustard, Mark Cancilla, Shang-Chiung Chen, Seongeun Julia Cho, Eugene Ciccimaro, Isabelle Cludts, Laurent Cocea, Celia D'Arienzo, Lieza Danan-Leon, Lorella Di Donato, Fabio Garofolo, Sam Haidar, Akiko Ishii-Watabe, Hao Jiang, John Kadavil, Sean Kassim, Pekka Kurki, Olivier Le Blaye, Kai Liu, Rod Mathews, Gustavo Mendes Lima Santos, Makoto Niwa, João Pedras-Vasconcelos, Mark Qian, Brian Rago, Ola Saad, Yoshiro Saito, Natasha Savoie, Dian Su, Matthew Szapacs, Nilufer Tampal, Stephen Vinter, Jian Wang, Jan Welink, Emma Whale, Amanda Wilson, Y-J Xue
The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid ligand binding assay (LBA)/LCMS and LBA approaches...
December 2017: Bioanalysis
https://www.readbyqxmd.com/read/29200314/assessment-of-structural-and-functional-similarity-of-biosimilar-products-rituximab-as-a-case-study
#18
Neh Nupur, Nidhi Chhabra, Rozaleen Dash, Anurag S Rathore
Biosimilars are products that are similar in terms of quality, safety, and efficacy to an already licensed reference/ innovator product and are expected to offer improved affordability. The most significant source of reduction in the cost of development of a biosimilar is the reduced clinical examination that it is expected to undergo as compared to the innovator product. However, this clinical relief is predicated on the assumption that there is analytical similarity between the biosimilar and the innovator product...
December 4, 2017: MAbs
https://www.readbyqxmd.com/read/29199066/abuse-liability-assessment-for-biologic-drugs-all-molecules-are-not-created-equal
#19
Christina L Zuch de Zafra, Carrie G Markgraf, David R Compton, Thomas J Hudzik
The development of novel drug candidates involves the thorough evaluation of potential efficacy and safety. To facilitate the safety assessment in light of global increases in prescription drug misuse/abuse, health authorities have developed guidance documents which provide a framework for evaluating the abuse liability of candidate therapeutics. The guidances do not distinguish between small molecules and biologics/biotherapeutics; however, there are key differences between these classes of therapeutics which are important drivers of concern for abuse...
December 2, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/29192343/a-view-on-the-importance-of-multi-attribute-method-for-measuring-purity-of-biopharmaceuticals-and-improving-overall-control-strategy
#20
Richard S Rogers, Michael Abernathy, Douglas D Richardson, Jason C Rouse, Justin B Sperry, Patrick Swann, Jette Wypych, Christopher Yu, Li Zang, Rohini Deshpande
Today, we are experiencing unprecedented growth and innovation within the pharmaceutical industry. Established protein therapeutic modalities, such as recombinant human proteins, monoclonal antibodies (mAbs), and fusion proteins, are being used to treat previously unmet medical needs. Novel therapies such as bispecific T cell engagers (BiTEs), chimeric antigen T cell receptors (CARTs), siRNA, and gene therapies are paving the path towards increasingly personalized medicine. This advancement of new indications and therapeutic modalities is paralleled by development of new analytical technologies and methods that provide enhanced information content in a more efficient manner...
November 30, 2017: AAPS Journal
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