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https://www.readbyqxmd.com/read/28105549/automated-antibody-de-novo-sequencing-and-its-utility-in-biopharmaceutical-discovery
#1
K Ilker Sen, Wilfred H Tang, Shruti Nayak, Yong J Kil, Marshall Bern, Berk Ozoglu, Beatrix Ueberheide, Darryl Davis, Christopher Becker
Applications of antibody de novo sequencing in the biopharmaceutical industry range from the discovery of new antibody drug candidates to identifying reagents for research and determining the primary structure of innovator products for biosimilar development. When murine, phage display, or patient-derived monoclonal antibodies against a target of interest are available, but the cDNA or the original cell line is not, de novo protein sequencing is required to humanize and recombinantly express these antibodies, followed by in vitro and in vivo testing for functional validation...
January 19, 2017: Journal of the American Society for Mass Spectrometry
https://www.readbyqxmd.com/read/28101473/purification-and-characterization-of-bovine-serum-albumin-using-chromatographic-method
#2
Sanaz Balkani, Sara Shamekhi, Ramin Raoufinia, Reza Parvan, Jalal Abdolalizadeh
Purpose: Albumin is an abundant protein of blood and has many biopharmaceutical applications. The aim of this study was to purify bovine serum albumin (BSA) using produced rabbit anti-BSA antibody. Methods: The polyclonal antibody was produced against the BSA in rabbits. Then, the pure BSA was injected to three white New Zealand rabbits. ELISA test was done to evaluate antibody production. After antibody purification,the purified antibody was attached to CNBr-activated sepharose and finally it was used for purification of albumin from bovine serum...
December 2016: Advanced Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/28100236/human-%C3%AE-defensin-2-production-from-s-cerevisiae-using-the-repressible-met17-promoter
#3
Thea S B Møller, Joanna Hay, Malcolm J Saxton, Karen Bunting, Evamaria I Petersen, Søren Kjærulff, Christopher J A Finnis
BACKGROUND: Baker's yeast Saccharomyces cerevisiae is a proven host for the commercial production of recombinant biopharmaceutical proteins. For the manufacture of heterologous proteins with activities deleterious to the host it can be desirable to minimise production during the growth phase and induce production late in the exponential phase. Protein expression by regulated promoter systems offers the possibility of improving productivity in this way by separating the recombinant protein production phase from the yeast growth phase...
January 18, 2017: Microbial Cell Factories
https://www.readbyqxmd.com/read/28098491/particle-sizing-methods-for-the-detection-of-protein-aggregates-in-biopharmaceuticals
#4
Akram Khodabandehloo, David Da Yong Chen
Protein aggregation is a common biological phenomenon which is responsible for degenerative diseases and is problematic in the pharmaceutical industry. According to the rules provided by regulatory agencies, industry is supposed to assess the product quality regarding the presence of subvisible particles. Also, they should evaluate the technologies that are used to measure these particles. Therefore, US FDA and industry have been looking for methods capable of accurately characterizing the protein products...
January 18, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28096378/biosynthesis-of-the-microtubule-destabilizing-diterpene-pseudolaric-acid-b-from-golden-larch-involves-an-unusual-diterpene-synthase
#5
Sibongile Mafu, Prema Sambandaswami Karunanithi, Teresa Ann Palazzo, Bronwyn Lee Harrod, Selina Marakana Rodriguez, Iris Natalie Mollhoff, Terrence Edward O'Brien, Shen Tong, Oliver Fiehn, Dean J Tantillo, Jörg Bohlmann, Philipp Zerbe
The diversity of small molecules formed via plant diterpene metabolism offers a rich source of known and potentially new biopharmaceuticals. Among these, the microtubule-destabilizing activity of pseudolaric acid B (PAB) holds promise for new anticancer agents. PAB is found, perhaps uniquely, in the coniferous tree golden larch (Pseudolarix amabilis, Pxa). Here we describe the discovery and mechanistic analysis of golden larch terpene synthase 8 (PxaTPS8), an unusual diterpene synthase (diTPS) that catalyzes the first committed step in PAB biosynthesis...
January 17, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/28094996/characterization-of-protein-excipient-microheterogeneity-in-biopharmaceutical-solid-state-formulations-by-confocal-fluorescence-microscopy
#6
Stijn H S Koshari, Jean L Ross, Purnendu K Nayak, Isidro E Zarraga, Karthikan Rajagopal, Norman J Wagner, Abraham M Lenhoff
Protein-stabilizer microheterogeneity is believed to influence long-term protein stability in solid-state biopharmaceutical formulations and its characterization is therefore essential for the rational design of stable formulations. However, the spatial distribution of the protein and the stabilizer in a solid-state formulation is, in general, difficult to characterize because of the lack of a functional, simple, and reliable characterization technique. We demonstrate the use of confocal fluorescence microscopy with fluorescently labeled monoclonal antibodies (mAbs) and antibody fragments (Fabs) to directly visualize three-dimensional particle morphologies and protein distributions in dried biopharmaceutical formulations, without restrictions on processing conditions or the need for extensive data analysis...
January 17, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28093941/novel-surface-engineered-solid-lipid-nanoparticles-of-rosuvastatin-calcium-for-low-density-lipoprotein-receptor-targeting-a-quality-by-design-driven-perspective
#7
Sarwar Beg, Sanyog Jain, Varun Kushwah, Gurjit Kaur Bhatti, Premjeet Singh Sandhu, O P Katare, Bhupinder Singh
AIM: The present studies describe Quality by Design-oriented development and characterization of surface-engineered solid lipid nanoparticles (SLNs) of rosuvastatin calcium for low density lipoprotein-receptor targeting. MATERIALS & METHODS: SLNs were systematically prepared employing Compritol 888 and Tween-80. Surface modification of SLNs was accomplished with Phospholipon 90G and DSPE-mPEG-2000 as the ligands for specific targeting to the low density lipoprotein-receptors...
January 17, 2017: Nanomedicine
https://www.readbyqxmd.com/read/28093327/amorphous-solid-dispersion-of-cyclosporine-a-prepared-with-fine-droplet-drying-process-physicochemical-and-pharmacokinetic-characterization
#8
Hiroki Suzuki, Tatsuru Moritani, Tadahiko Morinaga, Yoshiki Seto, Hideyuki Sato, Satomi Onoue
The present study aimed to develop an amorphous solid dispersion (ASD) of cyclosporine A (CsA) by a fine droplet drying (FDD) process for improvement in oral absorption of CsA. CsA and hydroxypropyl cellulose-SSL were dissolved in 1,4-dioxane, and the solution was powdered by the FDD process to obtain the ASD formulation of CsA (ASD/CsA). The ASD/CsA was characterized in terms of morphology, particle size distribution, crystallinity, dissolution behavior, physicochemical stability, and pharmacokinetic behavior in rats...
January 13, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28092854/biopharmaceutical-characterization-of-praziquantel-cocrystals-and-cyclodextrin-complexes-prepared-by-grinding
#9
Martina Cugovčan, Jasna Jablan, Jasmina Lovrić, Dominik Cinčić, Nives Galić, Mario Jug
Mechanochemical activation using several different co-grinding additives was applied as a green chemistry approach to improve physiochemical and biopharmaceutical properties of praziquantel (PZQ). Liquid assisted grinding with an equimolar amount of citric acid (CA), malic acid (MA), salicylic acid (SA) and tartaric acid (TA) gained in cocrystal formation, which all showed pH-dependent solubility and dissolution rate. However, the most soluble cocrystal of PZQ with MA was chemically unstable, as seen during the stability testing...
January 10, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28091715/highly-sensitive-glycosylamine-labelling-of-o-glycans-using-non-reductive-%C3%AE-elimination
#10
Kenichiro Furuki, Toshimasa Toyo'oka, Kazutoshi Ban
When developing biopharmaceuticals, glycans are the most important posttranslational protein modifications that must be addressed because they affect the between-protein interactions that maintain homeostasis. The glycan profile may be defined as a critical quality attribute of a biopharmaceutical. Comprehensive analysis of protein glycosylation must overcome challenges such as the release, labelling, separation and detection of O-glycans. In contrast, N-glycans can be readily released non-reductively from peptide backbones using an enzyme such as peptide N-glycosidase F...
January 14, 2017: Analytical and Bioanalytical Chemistry
https://www.readbyqxmd.com/read/28090277/anti-quorum-sensing-activity-of-substances-isolated-from-wild-berry-associated-bacteria
#11
Suha M Abudoleh, Adel M Mahasneh
BACKGROUND: Quorum Sensing (QS) is a mechanism used by bacteria to determine their physiological activities and coordinate gene expression based on cell to cell signaling. Many bacterial physiological functions are under the regulation of quorum sensing such as virulence, luminescence, motility, sporulation and biofilm formation. The aim of the present study was to isolate and characterize Quorum Sensing Inhibitory (QSI) substances from epiphytic bacteria residing on wild berries surfaces...
January 2017: Avicenna Journal of Medical Biotechnology
https://www.readbyqxmd.com/read/28088879/the-biopharmaceutical-classification-system-of-excipients
#12
Teófilo Vasconcelos, Sara Marques, Bruno Sarmento
The increasing number of new chemical entities is bringing new challenges to the field of drug delivery. These drugs present bioavailability issues that are frequently associated with intestinal metabolism or efflux mechanisms. Some excipients, particularly surfactants, have demonstrated a capacity to interfere with these mechanisms, improving drug bioavailability. Consequently, these excipients can no longer be considered as inert and should be subject to special considerations from a regulatory perspective...
February 2017: Therapeutic Delivery
https://www.readbyqxmd.com/read/28088541/secretory-pathway-optimization-of-cho-producer-cells-by-co-engineering-of-the-mitosrna-1978-target-genes-cers2-and-tbc1d20
#13
Lisa A Pieper, Michaela Strotbek, Till Wenger, Martin Gamer, Monilola A Olayioye, Angelika Hausser
Chinese Hamster Ovary (CHO) cells are the most commonly used host for the production of biopharmaceuticals. Although transcription and translation engineering strategies have been employed to generate high-producer cell clones, the secretory pathway still remains a bottleneck in cellular productivity. In this study we show that ectopic expression of a human mitochondrial genome-encoded small RNA (mitosRNA-1978) in an IgG expressing CHO cell line strongly improved specific productivity by functioning in a microRNA-like fashion...
January 11, 2017: Metabolic Engineering
https://www.readbyqxmd.com/read/28072827/comprehensive-n-glycan-profiling-of-cetuximab-biosimilar-candidate-by-np-hplc-and-maldi-ms
#14
Sheng Liu, Wenjie Gao, Yao Wang, Zhenyu He, Xiaojun Feng, Bi-Feng Liu, Xin Liu
Monitoring glycosylation of the mAbs have been emphasized and routinely characterized in biopharmaceutical industries because the carbohydrate components are closely related to the safety, efficacy, and consistency of the antibodies. In this study, the comprehensive glycan profiling of a biosimilar candidate of cetuximab was successfully characterized using Normal phase high-performance liquid chromatography (NP-HPLC) in combination with Matrix assisted laser desorption/ionization mass spectrometry (MALDI-MS)...
2017: PloS One
https://www.readbyqxmd.com/read/28054475/design-and-control-of-integrated-chromatography-column-sequences
#15
Niklas Andersson, Anton Löfgren, Marianne Olofsson, Anton Sellberg, Peter Tiainen, Bernt Nilsson
To increase the productivity in biopharmaceutical production a natural step is to introduce integrated continuous biomanufacturing which leads to fewer buffer and storage tanks, smaller sizes of integrated unit operations and full automation of the operation. The main contribution of this work is to illustrate a methodology for design and control of a downstream process based on integrated column sequences. For small scale production, e.g. pre-clinical studies, integrated column sequences can be implemented on a single chromatography system...
January 5, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/28054462/optimization-of-biopharmaceutical-downstream-processes-supported-by-mechanistic-models-and-artificial-neural-networks
#16
Silvia M Pirrung, Luuk A M van der Wielen, Ruud F W C Van Beckhoven, Emile J A X van de Sandt, Michel H M Eppink, Marcel Ottens
Downstream process development is a major area of importance within the field of bioengineering. During the design of such a downstream process, important decisions have to be made regarding the type of unit operations as well as their sequence and their operating conditions. Current computational approaches addressing these issues either show a high level of simplification or struggle with computational speed. Therefore, this article presents a new approach that combines detailed mechanistic models and speed-enhancing artificial neural networks...
January 5, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/28053073/in-vivo-imaging-in-pharmaceutical-development-and-its-impact-on-the-3rs
#17
Barry R Campbell, Dinko Gonzalez Trotter, Catherine D G Hines, Wenping Li, Manishkumar Patel, Weisheng Zhang, Jeffrey L Evelhoch
It is well understood that the biopharmaceutical industry must improve efficiency along the path from laboratory concept to commercial product. In vivo imaging is recognized as a useful method to provide biomarkers for target engagement, treatment response, safety, and mechanism of action. Imaging biomarkers have the potential to inform the selection of drugs that are more likely to be safe and effective. Most of the imaging modalities for biopharmaceutical research are translatable to the clinic. In vivo imaging does not require removal of tissue to provide biomarkers, thus reducing the number of valuable preclinical subjects required for a study...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28051868/quantifying-the-risks-of-asparagine-deamidation-and-aspartate-isomerization-in-biopharmaceuticals-by-computing-reaction-free-energy-surfaces
#18
Nikolay V Plotnikov, Satish Kumar Singh, Jason C Rouse, Sandeep Kumar
Early identification of asparagine deamidation and aspartate isomerization degradation sites can facilitate the successful development of biopharmaceuticals. Several knowledge-based models have been proposed to assess these degradation risks. In this study, we propose a physics-based approach to identify the degradation sites on the basis of the free-energy barriers along the prechemical conformational step and the chemical reaction pathway. These contributions are estimated from classical and quantum mechanics/molecular mechanics molecular dynamics simulations...
January 19, 2017: Journal of Physical Chemistry. B
https://www.readbyqxmd.com/read/28041968/medicines-for-pediatric-patients-biopharmaceutical-developmental-and-regulatory-considerations
#19
David P Elder, René Holm, Martin Kuentz
This commentary reflects current developments in pediatric medicine. The underpinning legislation in both Europe and the US has led to the initiation of an increased number of clinical trials in the pediatric population, but there are still a number of outstanding issues within this field. These include the differences in the physiology between adults and the very heterogeneous nature of pediatric patients. There is an ongoing scientific debate on the applicability of a Pediatric Biopharmaceutical Classification System (PBCS) to define when waivers for bioequivalence studies can be supported by in vitro dissolution...
December 29, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28035627/supramolecular-cocrystals-of-gliclazide-synthesis-characterization-and-evaluation
#20
Renu Chadha, Dimpy Rani, Parnika Goyal
PURPOSE: To prepare the supramolecular cocrystals of gliclazide (GL, a BCS class II drug molecule) via mechanochemical route, with the goal of improving physicochemical and biopharmaceutical properties. METHODS: Two cocrystals of GL with GRAS status coformers, sebacic acid (GL-SB; 1:1) and α-hydroxyacetic acid (GL-HA; 1:1) were screened out using liquid assisted grinding. The prepared cocrystals were characterized using thermal and analytical techniques followed by evaluation of antidiabetic activity and pharmacokinetic parameters...
December 29, 2016: Pharmaceutical Research
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