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https://www.readbyqxmd.com/read/29148835/2017-white-paper-on-recent-issues-in-bioanalysis-aren-t-bmv-guidance-guidelines-scientific-part-1-lcms-small-molecules-peptides-and-small-molecule-biomarkers
#1
Jan Welink, Eric Yang, Nicola Hughes, Brian Rago, Eric Woolf, Jens Sydor, Laura Coppola, Brad Ackermann, Wenkui Li, Stephen C Alley, Mark Arnold, Isabella Berger, Chad Briscoe, Michael Buonarati, Mark Bustard, Mark Cancilla, Seongeun Julia Cho, Jeff Duggan, Daniela Fraier, Fabio Garofolo, Rachel Green, Sam Haidar, Lucinda Hittle, Akiko Ishii-Watabe, Rafiq Islam, Rand Jenkins, Barry Jones, John Kadavil, Sean Kassim, Olga Kavetska, Olivier Le Blaye, Anita Lee, Hanlan Liu, John Mehl, Gustavo Mendes Lima Santos, Adrien Musuku, Ragu Ramanathan, Yoshiro Saito, Natasha Savoie, Scott Summerfield, Sekhar Surapaneni, Matthew Szapacs, Nilufer Tampal, Tom Verhaeghe, Stephen Vinter, Emma Whale
The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California from 3 April 2017 to 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 LBA/LCMS and ligand-binding assay (LBA) approaches...
November 17, 2017: Bioanalysis
https://www.readbyqxmd.com/read/29135730/a-novel-secretome-biotherapeutic-influences-regeneration-in-critical-size-bone-defects
#2
Alexander J Burdette, Teja Guda, Michelle E Thompson, Richard Banas, Forest Sheppard
Severe traumatic injuries often result in critical size bone defects, which are unable to heal without treatment. Autologous grafting is the standard of care but requires additional surgeries for graft procurement. Amnion-derived multipotent progenitor cells release a secretome of biomolecules identified as integral to the process of bone regeneration and angiogenesis. This secretome is currently under development as a biotherapeutic. The efficacy of this secretome biotherapeutic was evaluated in vitro on the proliferation and migration of mesenchymal stem cells and osteoprogenitor cells as well as in vivo using a critical size rat calvarial defect model...
November 9, 2017: Journal of Craniofacial Surgery
https://www.readbyqxmd.com/read/29130774/the-sweet-spot-for-biologics-recent-advances-in-characterization-of-biotherapeutic-glycoproteins
#3
Rόisín O'Flaherty, Irena Trbojević-Akmačić, Gordon Greville, Pauline M Rudd, Gordan Lauc
Glycosylation is recognized as a Critical Quality Attribute for therapeutic glycoproteins such as monoclonal antibodies, fusion proteins and therapeutic replacement enzymes. Hence, efficient and quantitative glycan analysis techniques have been increasingly important for their discovery, development and quality control. The aim of this review is to highlight relevant and recent advances in analytical technologies for characterization of biotherapeutic glycoproteins. Areas covered: The review gives an overview of the glycosylation trends of biotherapeutics approved in 2016 and 2017 by FDA...
November 13, 2017: Expert Review of Proteomics
https://www.readbyqxmd.com/read/29129068/structural-and-functional-characterization-of-a-hole-hole-homodimer-variant-in-a-knob-into-hole-bispecific-antibody
#4
Hui-Min Zhang, Charlene Li, Ming Lei, Victor Lundin, Ho Young Lee, Milady Ninonuevo, Kevin Lin, Guanghui Han, Wendy Sandoval, Dongsheng Lei, Gang Ren, Jennifer Zhang, Hongbin Liu
Bispecific antibodies have great potential to be the next-generation biotherapeutics due to their ability to simultaneously recognize two different targets. Compared to conventional monoclonal antibodies, knob-into-hole bispecific antibodies face unique challenges in production and characterization due to the increase in variant possibilities, such as homodimerization in covalent and non-covalent forms. In this study, a storage- and pH-sensitive hydrophobic interaction chromatography (HIC) profile change was observed for the hole-hole homodimer, and the multiple HIC peaks were explored and shown to be conformational isomers...
November 12, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/29122153/are-biotherapeutics-revolutionizing-treatment-of-allergic-diseases
#5
EDITORIAL
William W Busse
No abstract text is available yet for this article.
November 2017: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/29122152/biologic-agents-for-the-treatment-of-hypereosinophilic-syndromes
#6
Fei Li Kuang, Amy D Klion
Hypereosinophilic syndromes (HES) are a heterogeneous group of rare disorders defined by the presence of marked peripheral or tissue eosinophilia resulting in end-organ damage. Although conventional therapies, including glucocorticoids, hydroxyurea, and IFN-α, are initially effective in reducing eosinophilia and symptoms in a majority of patients with platelet-derived growth factor mutation-negative HES, the development of resistance and treatment-related toxicity are common. In contrast, targeted therapy with the tyrosine kinase inhibitor, imatinib, is well tolerated but effective only in the subset of patients with HES with a primary myeloid disorder...
November 2017: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/29115701/multispecificity-of-a-recombinant-anti-ras-monoclonal-antibody
#7
John W Schrader, Gary R McLean
Recombinant monoclonal antibodies (Ab's) have widespread application as research tools, diagnostic reagents and as biotherapeutics. Whilst studying the cellular molecular switch protein m-ras, a recombinant monoclonal antibody to m-ras was generated for use as a research tool. Antibody genes from a single rabbit B cell secreting IgG to an m-ras specific peptide sequence were expressed in mammalian cells, and monoclonal rabbit IgG binding was characterized by ELISA and peptide array blotting. Although the monoclonal Ab was selected for specificity to m-ras peptide, it also bound to both recombinant full-length m-ras and h-ras proteins...
November 8, 2017: Journal of Molecular Recognition: JMR
https://www.readbyqxmd.com/read/29115357/measuring-biotherapeutic-viscosity-and-degradation-on-chip-with-particle-diffusometry
#8
K N Clayton, D Lee, S T Wereley, T L Kinzer-Ursem
In the absence of efficient ways to test drug stability and efficacy, pharmaceuticals that have been stored outside of set temperature conditions are destroyed, often at great cost. This is especially problematic for biotherapeutics, which are highly sensitive to temperature fluctuations. Current platforms for assessing the stability of protein-based biotherapeutics in high throughput and in low volumes are unavailable outside of research and development laboratories and are not efficient for use in production, quality control, distribution, or clinical settings...
November 8, 2017: Lab on a Chip
https://www.readbyqxmd.com/read/29113434/similar-active-sites-and-mechanisms-do-not-lead-to-cross-promiscuity-in-organophosphate-hydrolysis-implications-for-biotherapeutic-engineering
#9
Miha Purg, Mikael Elias, Shina Caroline Lynn Kamerlin
Organophosphate hydrolases are proficient catalysts of the breakdown of neurotoxic organophosphates, and have great potential as both biotherapeutics for treating acute organophosphate toxicity, and as bioremediation agents. Yet proficient organophosphatases such as serum paraoxonase 1 (PON1) and the organophosphate-hydrolyzing lactonase SsoPox are unable to hydrolyze organophosphates with challenging leaving groups such as diisopropyl fluorophosphate (DFP) or venomous agent X (VX), creating a major challenge for enzyme design...
November 7, 2017: Journal of the American Chemical Society
https://www.readbyqxmd.com/read/29111637/synthesis-of-cellulose-graft-polypropionic-acid-nanofiber-cation-exchange-membrane-adsorbers-for-high-efficiency-separations
#10
Sahadevan Rajesh, Steven Schneiderman, Caitlin Crandall, Hao Fong, Todd J Menkhaus
Fabrication of membrane adsorbers with elevated binding capacity and high throughput is highly desired for simplifying and improving purification efficiencies of bioproducts (biotherapeutics, vaccines, etc.) in the biotechnological and biopharmaceutical industries. Here we demonstrate the preparation of a novel class of self-supported, cellulose-graft-polypropionic acid (CL-g-PPA) cation-exchange nanofiber membrane adsorbers under mild reaction conditions for the purification of positively charged therapeutic proteins...
November 13, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/29110222/recommendations-for-the-assessment-and-management-of-pre-existing-drug-reactive-antibodies-during-biotherapeutic-development
#11
Li Xue, Adrienne Clements-Egan, Lakshmi Amaravadi, Mary Birchler, Boris Gorovits, Meina Liang, Heather Myler, Shobha Purushothama, Marta Starcevic Manning, Crystal Sung
Anti-drug antibodies (ADA) pose a potential risk to patient safety and efficacy and are routinely monitored during clinical trials. Pre-existing drug-reactive antibodies are present in patients without prior drug exposure and are defined by their ability to bind to a component of the drug. These pre-existing drug-reactive antibodies are frequently observed and could represent an adaptive immune response of an individual who has been previously exposed to antigens with structural similarities to the biotherapeutic...
November 2017: AAPS Journal
https://www.readbyqxmd.com/read/29106996/chronic-rhinosinusitis-endotypes-biomarkers-and-treatment-response
#12
Jose Gurrola, Larry Borish
It is increasingly recognized that chronic rhinosinusitis (CRS) comprises a spectrum of different diseases with distinct clinical presentations and pathogenic mechanisms. Defining the distinct phenotypes and endotypes of CRS impacts prognosis and most importantly is necessary as the basis for making therapeutic decisions. The need for individualized defining of pathogenic mechanisms prior to initiating therapy extends to virtually all therapeutic considerations. This is clearly crucial with antibiotics where, barring an influence from their off-target anti-inflammatory pharmacological effects, an understanding of the role of individual biome predicts likelihood of therapeutic benefit...
October 26, 2017: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/29104947/improvements-in-protein-production-in-mammalian-cells-from-targeted-metabolic-engineering
#13
Anne Richelle, Nathan E Lewis
Bioprocess optimization has yielded powerful clones for biotherapeutic production. However, new genomic technologies allow more targeted approaches to cell line development. Here we review efforts to enhance protein production in mammalian cells through metabolic engineering. Most efforts aimed to reduce toxic byproducts accumulation to enhance protein productivity. However, recent work highlights the possibility of regulating other desirable traits (e.g., apoptosis and glycosylation) by targeting central metabolism since these processes are interconnected...
December 2017: Current opinion in systems biology
https://www.readbyqxmd.com/read/29075288/it-is-time-for-top-down-venomics
#14
REVIEW
Rafael D Melani, Fabio C S Nogueira, Gilberto B Domont
The protein composition of animal venoms is usually determined by peptide-centric proteomics approaches (bottom-up proteomics). However, this technique cannot, in most cases, distinguish among toxin proteoforms, herein called toxiforms, because of the protein inference problem. Top-down proteomics (TDP) analyzes intact proteins without digestion and provides high quality data to identify and characterize toxiforms. Denaturing top-down proteomics is the most disseminated subarea of TDP, which performs qualitative and quantitative analyzes of proteoforms up to ~30 kDa in high-throughput and automated fashion...
2017: Journal of Venomous Animals and Toxins Including Tropical Diseases
https://www.readbyqxmd.com/read/29065828/multimodal-chromatography-for-purification-of-biotherapeutics-a-review
#15
Vivek Halan, Sunit Maity, Rahul Bhambure, Anurag S Rathore
Process chromatography forms the core of purification of biotherapeutics. The unparalleled selectivity that it offers over other alternatives combined with the considerable robustness and scalability make it the unit operation of choice in downstream processing. It is typical to have three to five chromatography steps in a purification process for a biotherapeutic. Generally, these steps offer different modes of separation such as ion-exchange, reversed phase, size exclusion, and hydrophobic interaction. In the past decade, multimodal chromatography has emerged as an alternative to the traditional modes...
October 20, 2017: Current Protein & Peptide Science
https://www.readbyqxmd.com/read/29065238/cover-image-volume-114-number-12-december-2017
#16
Zhuangrong Huang, Dong-Yup Lee, Seongkyu Yoon
The cover image, by Zhuangrong Huang et al., is based on the Review Quantitative intracellular flux modeling and applications in biotherapeutic development and production using CHO cell cultures, DOI: 10.1002/bit.26384.
December 2017: Biotechnology and Bioengineering
https://www.readbyqxmd.com/read/29061102/delivering-natural-products-and-biotherapeutics-to-improve-drug-efficacy
#17
Mohammad A Obeid, Mohammed M Al Qaraghuli, Manal Alsaadi, Abdullah R Alzahrani, Kanidta Niwasabutra, Valerie A Ferro
Due to the increasing problem of drug resistance, new and improved medicines are required. Natural products and biotherapeutics offer a vast resource for new drugs; however, challenges, including the cost and time taken for traditional drug discovery processes and the subsequent lack of investment from the pharmaceutical industry, are associated with these areas. New techniques are producing compounds with appropriate activity at a faster rate. While the formulation of these combined with drug-delivery systems offers a promising approach for expanding the drug developments available to modern medicine...
November 2017: Therapeutic Delivery
https://www.readbyqxmd.com/read/29059618/development-of-a-robust-reporter-gene-based-assay-for-the-bioactivity-determination-of-il-5-targeted-therapeutic-antibodies
#18
Zhihao Fu, Chuanfei Yu, Lan Wang, Kai Gao, Gangling Xu, Wenbo Wang, Junxia Cao, Junzhi Wang
Eosinophilic asthma is characterized by the eosinophilic inflammation with the allergen independent activation of Th2 lymphocytes. Since IL-5 plays an important role in the maturation, survival and migration of eosinophils, hence the pathogenesis of eosinophilic asthma, biotherapeutics targeting IL-5/IL-5Rα have been developed and/or marketed, including Mepolizumab, Reslizumab, and Benralizumab. Accurate determination of bioactivity is crucial for the safety and efficacy of therapeutic antibodies. The current mode of action (MOA) based method used in the quality control and stability tests for anti-IL-5 mAbs is anti-proliferation assay, which is tedious with long duration and high variation...
September 28, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29058416/complete-nmr-assignment-of-succinimide-and-its-detection-and-quantification-in-peptides-and-intact-proteins
#19
Luigi Grassi, Christof Regl, Sabrina Wildner, Gabriele Gadermaier, Christian G Huber, Chiara Cabrele, Mario Schubert
Detecting and quantifying post-translational modifications (PTMs) in full-length proteins is a challenge, especially in the case of spontaneously occurring, nonenzymatic PTMs. Such a PTM is the formation of succinimide (Snn) in a protein that occurs spontaneously in prone primary sequences and leads typically to an equilibrium between Snn and its hydrolysis products isoaspartate (isoAsp) and aspartate. In order to detect these modifications in proteins by NMR spectroscopy, chemical shift assignments of reference compounds are required...
November 7, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/29054922/protein-turnover-measurements-in-human-serum-by-serial-immunoaffinity-lc-ms-ms
#20
Vahid Farrokhi, Xiaoying Chen, Hendrik Neubert
BACKGROUND: The half-life of target proteins is frequently an important parameter in mechanistic pharmacokinetic and pharmacodynamic (PK/PD) modeling of biotherapeutics. Clinical studies for accurate measurement of physiologically relevant protein turnover can reduce the uncertainty in PK/PD model-based predictions, for example, of the therapeutic dose and dosing regimen in first-in-human clinical trials. METHODS: We used a targeted mass spectrometry work flow based on serial immunoaffinity enrichment of multiple human serum proteins from a [5,5,5-(2)H3]-L-leucine tracer pulse-chase study in healthy volunteers...
October 20, 2017: Clinical Chemistry
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