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https://www.readbyqxmd.com/read/28224392/investigation-of-need-of-natural-bioenhancer-for-a-metabolism-susceptible-drug-raloxifene-in-a-designed-self-emulsifying-drug-delivery-system
#1
Poonam Singh Thakur, Narinder Singh, Abhay T Sangamwar, Arvind Kumar Bansal
Bioenhancers can increase the bioavailability of metabolism susceptible drugs. The present study was designed to understand the impact of bioenhancer on permeability and bioavailability of a biopharmaceutical drug disposition classification system (BDDCS) class II drug raloxifene (RLX). RLX undergoes extensive first pass metabolism by UGT enzymes in gastrointestinal tract (GIT) and has an oral bioavailability of about 2%. Self-emulsifying drug delivery system (SEDDS) of RLX was developed using a designed approach and this formulation was loaded with reported bioenhancers: quercetin and piperine...
February 21, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28223229/theranostic-of-biopharmaceuticals
#2
REVIEW
Benjamin Chaigne, Hervé Watier
Monoclonal antibodies (mAbs) and fusion proteins with an Fc portion of immunoglobulin G (IgG) are emblematic of the remarkable expansion of biopharmaceuticals. Despite their biological origin, these products display an interindividual variability in their efficacy and/or side effects, which must be taken into consideration. Biological monitoring allowing for adapted prescription and dose adjustments may lead to therapeutic optimization and limitation of the high costs of these drugs. Herein, we review the biological theranostic of mAbs and Fc fusion proteins, including pre-treatment analyses, monitoring of efficacy, therapeutic drug monitoring, and monitoring of side effects...
February 13, 2017: Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28216581/biopharmaceutical-characterization-and-bioavailability-study-of-a-tetrazole-analog-of-clofibric-acid-in-rat
#3
Nancy Vara-Gama, Adriana Valladares-Méndez, Gabriel Navarrete-Vazquez, Samuel Estrada-Soto, Luis Manuel Orozco-Castellanos, Julio César Rivera-Leyva
In the current investigation, the physicochemical, biopharmaceutical and pharmacokinetic characterization of a new clofibric acid analog (Compound 1) was evaluated. Compound 1 showed affinity by lipophilic phase in 1 to 5 pH interval, indicating that this compound would be absorbed favorably in duodenum or jejunum. Also, Compound 1 possess two ionic species, first above of pH 4.43 and, the second one is present over pH 6.08. The apparent permeability in everted sac rat intestine model was 8.73 × 10(-6) cm/s in duodenum and 1...
February 14, 2017: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
https://www.readbyqxmd.com/read/28213844/self-nanoemulsified-drug-delivery-system-of-hydrochlorothiazide-for-increasing-dissolution-rate-and-diuretic-activity
#4
Cassiana Mendes, Aline Buttchevitz, Jéssica Henriques Kruger, Thiago Caon, Patricia de Oliveira Benedet, Elenara Lemos-Senna, Marcos Antônio Segatto Silva
Hydrochlorothiazide (HCTZ) is a class IV drug according to the Biopharmaceutical Classification System. This study aimed the development of self-nanoemulsifying drug delivery system (SNEDDS) for HCTZ as an approach to overcome the biopharmaceutical limitations. Pre-formulation screening and ternary phase diagrams were carried out to select the oil phase, the surfactant, and the co-surfactant as the amount of each constituent. The optimized formulations, with reduced amount of surfactant, and composed of medium chain triglycerides, Cremophor EL and Transcutol P did not affect the pH or show drug incompatibilities...
February 17, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28213177/tiered-analytics-for-purity-assessment-of-macrocyclic-peptides-in-drug-discovery-analytical-consideration-and-method-development
#5
Jingfang Jenny Qian Cutrone, Xiaohua Stella Huang, Edward S Kozlowski, Ye Bao, Yingzi Wang, Christopher S Poronsky, Dieter M Drexler, Adrienne A Tymiak
Synthetic macrocyclic peptides with natural and unnatural amino acids have gained considerable attention from a number of pharmaceutical/biopharmaceutical companies in recent years as a promising approach to drug discovery, particularly for targets involving protein-protein or protein-peptide interactions. Analytical scientists charged with characterizing these leads face multiple challenges including dealing with a class of complex molecules with the potential for multiple isomers and variable charge states and no established standards for acceptable analytical characterization of materials used in drug discovery...
February 3, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28211938/establishment-and-validation-of-a-microfluidic-capillary-gel-electrophoresis-platform-method-for-purity-analysis-of-therapeutic-monoclonal-antibodies
#6
Michael T Smith, Shu Zhang, Troy Adams, Byron DiPaolo, Jennifer Dally
Capillary and microfluidic chip electrophoresis technologies are heavily utilized for development, characterization, release, and stability testing of biopharmaceuticals. Within the biopharmaceutical industry, CE-SDS and M-CGE are commonly used for purity determination by separation and quantitation of size-based variants. M-CGE is used primarily as a R&D tool for product and process development, while cGMP release and stability testing applications are commonly reserved for CE-SDS. This paper describes the establishment of a M-CGE platform method to be used for R&D and cGMP applications, including release and stability testing, for monoclonal antibodies...
February 17, 2017: Electrophoresis
https://www.readbyqxmd.com/read/28208257/hydrophilic-interaction-chromatography-hyphenated-with-mass-spectrometry-a-powerful-analytical-tool-for-the-comparison-of-originator-and-biosimilar-therapeutic-monoclonal-antibodies-at-the-middle-up-level-of-analysis
#7
Valentina D'Atri, Szabolcs Fekete, Alain Beck, Matthew Lauber, Davy Guillarme
The development and approval processes of biosimilar mAbs depend on their comparability to originators. Therefore, analytical comparisons are required to assess structural features and post-translational modifications (PTM) and thereby minimize the risk of being clinically meaningful differences between biosimilar and originator drug products. The glycosylation pattern of mAbs is considered to be an important critical quality attribute (CQA), and several analytical approaches have been proposed that facilitate characterizing and monitoring a glycosylation profile, albeit mainly at a glycan and glycopeptide level of analysis...
February 7, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28207284/characterization-and-qc-of-biopharmaceuticals-by-ms-based-multi-attribute-method-advantages-and-challenges
#8
Yun Zhang, Jingzhong Guo
No abstract text is available yet for this article.
February 16, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28206763/rational-design-of-a-polymer-with-robust-efficacy-for-intracellular-protein-and-peptide-delivery
#9
Hong Chang, Jia Lv, Xin Gao, Xing Wang, Hui Wang, Hui Chen, Xu He, Lei Li, Yiyun Cheng
The efficient delivery of biopharmaceutical drugs such as proteins and peptides into the cytosol of target cells poses substantial challenges owing to their large size and susceptibility to degradation. Current protein delivery vehicles have limitations such as the need for protein modification, insufficient delivery of large-size proteins or small peptides, and loss of protein function after the delivery. Here, we adopted a rational approach to design a polymer with robust efficacy for intracellular protein and peptide delivery...
February 20, 2017: Nano Letters
https://www.readbyqxmd.com/read/28195732/in-vivo-predictive-dissolution-ipd-and-biopharmaceutical-modeling-and-simulation-future-use-of-modern-approaches-and-methodologies-in-a-regulatory-context
#10
H Lennernas, A Lindahl, A Van Peer, C Ollier, T Flanagan, R Lionberger, A Nordmark, S Yamashita, L Yu, G L Amidon, V Fischer, E Sjögren, P Zane, M McAllister, B Abrahamsson
The overall objective of OrBiTo, a project within Innovative Medicines Initiative (IMI), is to streamline and optimize the development of orally administered drug products through the creation and efficient application of biopharmaceutics tools. This toolkit will include both experimental and computational models developed on improved understanding of the highly dynamic gastrointestinal (GI) physiology relevant to the GI absorption of drug products in both fasted and fed states. A part of the annual OrBiTo-meeting in 2015 was dedicated to the presentation of the most recent progress in the development of the regulatory use of PBPK in silico modeling, in vivo predictive dissolution (IPD) tests and their application to biowaivers...
February 14, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28194741/deciphering-the-biophysical-effects-of-oxidizing-sulfur-containing-amino-acids-in-interferon-beta-1a-using-ms-and-hdx-ms
#11
Damian J Houde, George M Bou-Assaf, Steven A Berkowitz
Introduction of a chemical change to one or more amino acids in a protein's polypeptide chain can result in various effects on its higher-order structure (HOS) and biophysical behavior (or properties). These effects range from no detectable change to significant structural or conformational alteration that can greatly affect the protein's biophysical properties and its resulting biological function. The ability to reliably detect the absence or presence of such changes is essential to understanding the structure-function relationship in a protein and in the successful commercial development of protein-based drugs (biopharmaceuticals)...
February 13, 2017: Journal of the American Society for Mass Spectrometry
https://www.readbyqxmd.com/read/28192978/in-vitro-functional-quality-characterization-of-nota-modified-somatropins
#12
Nathalie Bracke, Han Yao, Evelien Wynendaele, Frederick Verbeke, Xiaolong Xu, Bert Gevaert, Alex Maes, Christophe Van de Wiele, Mike Sathekge, Sarah De Saeger, Bart M J De Spiegeleer
Chemical modifications on protein biopharmaceuticals introduce extra variability in addition to their inherent complexity, hence require more comprehensive analytical and functional characterization during their discovery, development and manufacturing. Somatropin (i.e. recombinant human growth hormone, rhGH) modified with the chelating agent S-2-(4-isothiocyanatobenzyl)-1,4,7-triazacyclononane-1,4,7-triacetic acid (p-SCN-Bn-NOTA) allows the incorporation of radiometals for research and possible theranostic purposes...
January 31, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28188928/the-papain-like-cysteine-proteinases-nbcysp6-and-nbcysp7-are-highly-processive-enzymes-with-substrate-specificities-complementary-to-nicotiana-benthamiana-cathepsin-b
#13
Melanie Paireder, Stefan Tholen, Andreas Porodko, Martin L Biniossek, Bettina Mayer, Marko Novinec, Oliver Schilling, Lukas Mach
The tobacco-related plant Nicotiana benthamiana is gaining interest as a versatile host for the production of monoclonal antibodies and other protein therapeutics. However, the susceptibility of plant-derived recombinant proteins to endogenous proteolytic enzymes limits their use as biopharmaceuticals. We have now identified two previously uncharacterized N. benthamiana proteases with high antibody-degrading activity, the papain-like cysteine proteinases NbCysP6 and NbCysP7. Both enzymes are capable of hydrolysing a wide range of synthetic substrates, although only NbCysP6 tolerates basic amino acids in its specificity-determining S2 subsite...
February 7, 2017: Biochimica et Biophysica Acta
https://www.readbyqxmd.com/read/28188893/ultra-deep-next-generation-mitochondrial-genome-sequencing-reveals-widespread-heteroplasmy-in-chinese-hamster-ovary-cells
#14
Paul S Kelly, Colin Clarke, Alan Costello, Craig Monger, Justine Meiller, Heena Dhiman, Nicole Borth, Michael J Betenbaugh, Martin Clynes, Niall Barron
Recent sequencing of the Chinese hamster ovary (CHO) cell and Chinese hamster genomes has dramatically advanced our ability to understand the biology of these mammalian cell factories. In this study, we focus on the powerhouse of the CHO cell, the mitochondrion. Utilizing a high-resolution next generation sequencing approach we sequenced the Chinese hamster mitochondrial genome for the first time and surveyed the mutational landscape of CHO cell mitochondrial DNA (mtDNA). Depths of coverage ranging from ~3,319X to 8,056X enabled accurate identification of low frequency mutations (>1%) revealing that mtDNA heteroplasmy is widespread in CHO cells...
February 7, 2017: Metabolic Engineering
https://www.readbyqxmd.com/read/28188692/bioreactor-scale-up-and-protein-product-quality-characterization-of-piggybac-transposon-derived-cho-pools
#15
Yashas Rajendra, Sowmya Balasubramanian, Robert B Peery, James R Swartling, Neil A McCracken, Dawn L Norris, Christopher C Frye, Gavin C Barnard
Chinese hamster ovary (CHO) cells remain the most popular host for the production of biopharmaceutical drugs, particularly monoclonal antibodies (mAbs), bispecific antibodies and Fc-fusion proteins. Creating and characterizing the stable CHO clonally-derived cell lines (CDCLs) needed to manufacture these therapeutic proteins is a lengthy and laborious process. Therefore, CHO pools have increasingly been used to rapidly produce protein to support and enable preclinical drug development. We recently described the generation of CHO pools yielding mAb titers as high as 7...
February 11, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/28170401/clinical-practice-of-analysis-of-anti-drug-antibodies-against-interferon-beta-and-natalizumab-in-multiple-sclerosis-patients-in-europe-a-descriptive-study-of-test-results
#16
Jenny Link, Ryan Ramanujam, Michael Auer, Malin Ryner, Signe Hässler, Delphine Bachelet, Cyprien Mbogning, Clemens Warnke, Dorothea Buck, Poul Erik Hyldgaard Jensen, Claudia Sievers, Kathleen Ingenhoven, Nicolas Fissolo, Raija Lindberg, Verena Grummel, Naoimh Donnellan, Manuel Comabella, Xavier Montalban, Bernd Kieseier, Per Soelberg Sørensen, Hans-Peter Hartung, Tobias Derfuss, Andy Lawton, Dan Sikkema, Marc Pallardy, Bernhard Hemmer, Florian Deisenhammer, Philippe Broët, Pierre Dönnes, Julie Davidson, Anna Fogdell-Hahn
Antibodies against biopharmaceuticals (anti-drug antibodies, ADA) have been a well-integrated part of the clinical care of multiple sclerosis (MS) in several European countries. ADA data generated in Europe during the more than 10 years of ADA monitoring in MS patients treated with interferon beta (IFNβ) and natalizumab have been pooled and characterized through collaboration within a European consortium. The aim of this study was to report on the clinical practice of ADA testing in Europe, considering the number of ADA tests performed and type of ADA assays used, and to determine the frequency of ADA testing against the different drug preparations in different countries...
2017: PloS One
https://www.readbyqxmd.com/read/28170017/quantitative-glycomics-using-liquid-phase-separations-coupled-to-mass-spectrometry
#17
REVIEW
Josh Smith, Stefan Mittermayr, Csaba Váradi, Jonathan Bones
Post-translational modification of proteins by the attachment of glycans is governed by a variety of highly specific enzymes and is associated with fundamental impacts on the parent protein's physical, chemical and biological properties. The inherent connection between cellular physiology and specific glycosylation patterns has been shown to offer potential for diagnostic and prognostic monitoring of altered glycosylation in the disease state. Conversely, glycoprotein based biopharmaceuticals have emerged as dominant therapeutic strategies in the treatment of intricate diseases...
February 7, 2017: Analyst
https://www.readbyqxmd.com/read/28168318/endophyte-bioprospecting-in-south-asian-medicinal-plants-an-attractive-resource-for-biopharmaceuticals
#18
REVIEW
Rabia Tanvir, Aqeel Javeed, Aamir Ghafoor Bajwa
From the last several years, there has been an increasing interest in plant-associated bacteria commonly referred to as endophytes that reside asymptomatically in the internal plant tissues. This interest peaked since the last two decades due to the recognition that endophytes within medicinal plants have the capability to mimic and produce the bioactive metabolites of the host plant. A number of medicinal plants have been used for centuries by the people of South Asia to cure various diseases and this has led to abundant usage experience...
February 6, 2017: Applied Microbiology and Biotechnology
https://www.readbyqxmd.com/read/28165356/n-glycoprofiling-analysis-for-carbohydrate-composition-and-site-occupancy-determination-in-a-poly-glycosylated-protein-human-thyrotropin-of-different-origins
#19
Maria Teresa C P Ribela, Renata Damiani, Felipe D Silva, Eliana R Lima, João E Oliveira, Cibele N Peroni, Peter A Torjesen, Carlos R Soares, Paolo Bartolini
Human thyrotropin (hTSH) is a glycoprotein with three potential glycosylation sites: two in the α-subunit and one in the β-subunit. These sites are not always occupied and occupancy is frequently neglected in glycoprotein characterization, even though it is related to folding, trafficking, initiation of inflammation and host defense, as well as congenital disorders of glycosylation (CDG). For the first time N-glycoprofiling analysis was applied to the site-occupancy determination of two native pituitary hTSH, in comparison with three recombinant preparations of hTSH, a widely used biopharmaceutical...
February 3, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28161546/evaluation-of-changes-in-promoters-use-of-ucoes-and-chain-order-to-improve-the-antibody-production-in-cho-cells
#20
Maria Del Refugio Rocha-Pizaña, Guadalupe Ascencio-Favela, Brenda Maribell Soto-García, Margarita de la Luz Martinez-Fierro, Mario Moisés Alvarez
Therapy with biopharmaceuticals, mainly recombinant antibodies, offers patients higher life expectancy and better life quality than pharmacologic therapy. Countries with the highest scientific development are investing in this kind of therapy, and this is why the optimization of the production of these recombinant proteins would lead to their higher production and lower costs of the final product. Modifications in the use of promoters, the use of recombination regions, and the change in the order of the chains, are some of the genetic engineering changes that can increase the production of recombinant antibodies...
February 2, 2017: Protein Expression and Purification
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