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https://www.readbyqxmd.com/read/29036273/scoop-an-accurate-and-fast-predictor-of-protein-stability-curves-as-a-function-of-temperature
#1
Fabrizio Pucci, Jean Marc Kwasigroch, Marianne Rooman
Motivation: The molecular bases of protein stability remain far from elucidated even though substantial progress has been made through both computational and experimental investigations. One of the most challenging goals is the development of accurate prediction tools of the temperature dependence of the standard folding free energy Δ G ( T ). Such predictors have an enormous series of potential applications, which range from drug design in the biopharmaceutical sector to the optimization of enzyme activity for biofuel production...
June 26, 2017: Bioinformatics
https://www.readbyqxmd.com/read/29030242/orodispersible-dosage-forms-biopharmaceutical-improvements-and-regulatory-requirements
#2
REVIEW
Francesco Cilurzo, Umberto M Musazzi, Silvia Franzé, Francesca Selmin, Paola Minghetti
Orodispersible dosage forms have a growing presence in the pharmaceutical market because their administration can improve the bioavailability of some drugs and their prescription can ameliorate patient adherence and/or compliance. Here, we review the main features of orodispersible tablets, including oral lyophilisates, and orodispersible films along with their main production technologies. We summarize the bioavailability data and critically discussed their potential to improve patient adherence and/or compliance...
October 13, 2017: Drug Discovery Today
https://www.readbyqxmd.com/read/29029979/immunoaffinity-capture-coupled-with-capillary-electrophoresis-mass-spectrometry-to-study-protein-therapeutic-stability-in-vivo
#3
Mei Han, Josh T Pearson, Yunan Wang, Dwight Winters, Marcus Soto, Dan A Rock, Brooke M Rock
Protein engineering is at an all-time high in biopharmaceutics. As a result, absorption, distribution, metabolism and excretion (ADME) of proteins has become more important to understand in the context of engineering strategies to optimize therapeutic properties of potential lead constructs. Immunoaffinity capture coupled with a newly developed capillary electrophoresis - mass spectrometry (CE-MS) system was used to characterize intact protein mass analysis of a wildtype Fc-FGF21 construct and a sequence re-engineered Fc-FGF21 construct from an in vivo study...
October 10, 2017: Analytical Biochemistry
https://www.readbyqxmd.com/read/29027631/detrimental-roles-of-tnf-alpha-in-the-antiphospholipid-syndrome-and-de-novo-synthesis-of-antiphospholipid-antibodies-induced-by-biopharmaceuticals-against-tnf-alpha
#4
REVIEW
Mirjana Bećarević
Antiphospholipid syndrome (APS) is an autoimmune disease that is characterized by arterial and/or venous thrombosis and/or recurrent pregnancy losses. Obstetric APS (OAPS) is considered as a distinct entity from vascular APS (VAPS). In the absence of any additional disease, APS is designated as primary (PAPS), while the term secondary APS (SAPS) is used when other diseases are associated. Catastrophic APS (CAPS) is characterized by the rapid development of multiple thrombosis in various vital organs. The presence of antiphospholipid antibodies (aPL Abs) is considered as a laboratory criterion for APS diagnosis...
October 13, 2017: Journal of Thrombosis and Thrombolysis
https://www.readbyqxmd.com/read/29024509/adding-a-new-separation-dimension-to-ms-and-lc-ms-what-is-the-utility-of-ion-mobility-spectrometry
#5
Valentina D'Atri, Tim Causon, Oscar Hernandez-Alba, Aline Mutabazi, Jean-Luc Veuthey, Sarah Cianferani, Davy Guillarme
Ion mobility spectrometry is an analytical technique known for more than 100 years, which entails separating ions in the gas phase based on their size, shape and charge. While ion mobility spectrometry alone can be useful for some applications (mostly security analysis for detecting certain classes of narcotics and explosives), it becomes even more powerful in combination with mass spectrometry and high-performance liquid chromatography. Indeed, the limited resolving power of ion mobility spectrometry alone can be tackled when combining this analytical strategy with mass spectrometry or liquid chromatography with mass spectrometry...
October 12, 2017: Journal of Separation Science
https://www.readbyqxmd.com/read/29023997/trans-acting-oligodeoxythymidine-phosphorothioate-triester-reagents-for-transient-transfection-optimized-and-facilitated-by-a-high-throughput-microbioreactor-system
#6
Chih-Jung Hsu, Harsh V Jain, Abasha Williams, Julie Wang, Scott C Lute, Serge L Beaucage, Kurt A Brorson
A rapid and cost-effective transient transfection method for mammalian cells is essential for screening biopharmaceuticals in early stages of development. A library of 25 amphipathic trans-acting oligodeoxythymidine phosphorothioate triester (dTtaPS) transfection reagents, carrying positively charged and lipophilic groups, has been constructed for this purpose. High-throughput screening of the library, using an imaging cytometer and an automated microbioreactor system, has led to the identification of dTtaPS(10+) as a potent transfection reagent...
October 10, 2017: Biotechnology and Applied Biochemistry
https://www.readbyqxmd.com/read/29023375/workflow-for-criticality-assessment-applied-in-biopharmaceutical-process-validation-stage-1
#7
Thomas Zahel, Lukas Marschall, Sandra Abad, Elena Vasilieva, Daniel Maurer, Eric M Mueller, Patrick Murphy, Thomas Natschläger, Cécile Brocard, Daniela Reinisch, Patrick Sagmeister, Christoph Herwig
Identification of critical process parameters that impact product quality is a central task during regulatory requested process validation. Commonly, this is done via design of experiments and identification of parameters significantly impacting product quality (rejection of the null hypothesis that the effect equals 0). However, parameters which show a large uncertainty and might result in an undesirable product quality limit critical to the product, may be missed. This might occur during the evaluation of experiments since residual/un-modelled variance in the experiments is larger than expected a priori...
October 12, 2017: Bioengineering
https://www.readbyqxmd.com/read/29022380/curcumin-or-bisdemethoxycurcumin-for-nose-to-brain-treatment-of-alzheimer-disease-a-bio-chemo-informatics-case-study
#8
Rania M Hathout, Sherweit H El-Ahmady, AbdelKader A Metwally
The current study introduces a new idea of utilising several bio/chemoinformatics tools in comparing two bio-similar natural molecules viz. curcumin and bisdemethoxycurcumin (BDMC) in order to select a potential nose-to-brain remedy for Alzheimer disease. The comparison comprised several bio/chemo informatics tools. It encompassed all levels starting from loading the drug in a certain carrier; PLGA nanoparticles, to the biopharmaceutical level investigating the interaction with mucin and inhibition of P-gp blood-brain barrier efflux pumps...
October 12, 2017: Natural Product Research
https://www.readbyqxmd.com/read/29020279/cost-drivers-of-a-hospital-acquired-bacterial-pneumonia-and-ventilator-associated-bacterial-pneumonia-habp-vabp-phase-three-clinical-trial
#9
Stella Stergiopoulos, Sara B Calvert, Carrie A Brown, Josephine Awatin, Pamela Tenaerts, Thomas L Holland, Joseph A DiMasi, Kenneth A Getz
Background: Studies indicate that the prevalence of multi-drug resistant infections, including hospital acquired and ventilator associated bacterial pneumonia (HABP/VABP), has been rising. There are many challenges associated with these disease conditions and the ability to develop new treatments. Additionally, HABP/VABP clinical trials are very costly to conduct given their complex protocol designs and the difficulty in recruiting and retaining patients. Methodology: With input from clinicians, representatives from industry, and the Food and Drug Administriation (FDA), we conducted a study to (1) evaluate the drivers of HABP/VABP phase 3 direct and indirect clinical trial costs, (2) to identify opportunities to lower these costs, and (3) to compare (1) and (2) to endocrine and oncology clinical trials...
August 17, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29016568/the-availability-of-jobs-in-the-biopharmaceutical-industry-is-45-fold-greater-for-hematology-oncology-than-medical-specialties
#10
V Kaestner, V Prasad
No abstract text is available yet for this article.
September 15, 2017: Blood Cancer Journal
https://www.readbyqxmd.com/read/28993217/mechanistic-pbpk-modeling-of-the-dissolution-and-food-effect-of-a-bcs-iv-compound-the-venetoclax-story
#11
Arian Emami Riedmaier, David J Lindley, Jeffrey A Hall, Steven Castleberry, Russell T Slade, Patricia Stuart, Robert A Carr, Thomas B Borchardt, Daniel A J Bow, Marjoleen Nijsen
PURPOSE: Venetoclax, a selective B-cell lymphoma-2 inhibitor, is a biopharmaceutics classification system (BCS) class IV compound. The aim of this study was to develop a physiologically-based pharmacokinetic (PBPK) model to mechanistically describe absorption and disposition of an amorphous solid dispersion (ASD) formulation of venetoclax in humans. METHODS: A mechanistic PBPK model was developed incorporating measured amorphous solubility, dissolution, metabolism and plasma protein binding...
October 6, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28990739/advances-in-native-high-performance-liquid-chromatography-and-intact-mass-spectrometry-for-the-characterization-of-biopharmaceutical-products
#12
REVIEW
Marco Tassi, Jelle De Vos, Sneha Chatterjee, Frank Sobott, Jonathan Bones, Sebastiaan Eeltink
The characterization of biotherapeutics represents a major analytical challenge. This review discusses the current state-of-the-art in analytical technologies to profile biopharma products under native conditions, i.e., the protein 3D conformation is maintained during liquid chromatographic analysis. Native liquid-chromatographic modes that are discussed include aqueous size-exclusion chromatography, hydrophobic interaction chromatography, and ion-exchange chromatography. Infusion conditions and the possibilities and limitations to hyphenate native liquid chromatography to mass spectrometry are discussed...
October 9, 2017: Journal of Separation Science
https://www.readbyqxmd.com/read/28987867/neuroprotective-effect-of-a-new-variant-of-epo-nonhematopoietic-against-oxidative-stress
#13
C Castillo, S Zaror, M Gonzalez, A Hidalgo, C F Burgos, O I Cabezas, F Hugues, S P Jiménez, E González-Horta, I González-Chavarría, J Gavilán, R Montesino, O Sánchez, Manuela G Lopez, J Fuentealba, J R Toledo
Human erythropoietin is mainly recognized for its hematopoietic function; however, by binding to its receptor (EpoR), it can activate different signaling pathways as STAT, PI3K, MAPK and RAS to increase cellular differentiation or provide neuroprotective effects, among others. A recombinant human erythropoietin variant with low glycosylation and without hematopoietic effect (EpoL) was purified from skimmed goat milk. Recombinant human erythropoietin (Epo) was obtained from CHO cell line and used as control to compare EpoL effects...
September 21, 2017: Redox Biology
https://www.readbyqxmd.com/read/28987537/tuning-the-rheological-properties-of-an-ammonium-methacrylate-copolymer-for-the-design-of-adhesives-suitable-for-transdermal-patches
#14
Gaia M G Quaroni, Chiara G M Gennari, Francesco Cilurzo, Guylaine Ducouret, Costantino Creton, Paola Minghetti
Eudragit® RL (EuRL) matrices have been proposed to release a drug to the skin. However, no information is available on both viscoelastic and adhesive properties of such compositions. This work focuses on the evaluation of both rheological and texture properties of EuRL differently plasticized with tributyl citrate (TBC) or triacetin (TRI) in order to design a pressure sensitive adhesive suitable for transdermal patch preparation. The patch adhesive properties (i.e. tack, peel adhesion and shear adhesion) as well as its in vitro biopharmaceutical performances were determined after loading ibuprofen, ketoprofen or flurbiprofen...
October 5, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28982324/nanoprecipitation-for-poorly-water-soluble-drugs
#15
Thao Tran
Approximately 60% of the active pharmaceutical ingredients (APIs) in today's pharmaceutical industry are poorly water soluble drugs, and they are classified as BCS (Biopharmaceutics Classification System) class II compounds. Within the scope of this review, nanoprecipitation methods for poorly water soluble drugs as well as solvent removal techniques will be discussed.
October 4, 2017: Current Drug Metabolism
https://www.readbyqxmd.com/read/28977454/in-silico-design-of-context-responsive-mammalian-promoters-with-user-defined-functionality
#16
Adam J Brown, Suzanne J Gibson, Diane Hatton, David C James
Comprehensive de novo-design of complex mammalian promoters is restricted by unpredictable combinatorial interactions between constituent transcription factor regulatory elements (TFREs). In this study, we show that modular binding sites that do not function cooperatively can be identified by analyzing host cell transcription factor expression profiles, and subsequently testing cognate TFRE activities in varying homotypic and heterotypic promoter architectures. TFREs that displayed position-insensitive, additive function within a specific expression context could be rationally combined together in silico to create promoters with highly predictable activities...
August 30, 2017: Nucleic Acids Research
https://www.readbyqxmd.com/read/28972297/progress-in-biopharmaceutical-development
#17
Malgorzata Kesik-Brodacka
Since its introduction in 1982, biopharmaceutical drugs have revolutionized the treatment of a broad spectrum of diseases and are increasingly used in nearly all branches of medicine. In recent years, the biopharmaceuticals market has developed much faster than the market for all drugs and is believed to have great potential for further dynamic growth because of the tremendous demand for these drugs. Biobetters, which contain altered active pharmaceutical ingredients with enhanced efficacy, will play an important role in the development of biopharmaceuticals...
October 3, 2017: Biotechnology and Applied Biochemistry
https://www.readbyqxmd.com/read/28971365/investigating-oral-absorption-of-carbamazepine-in-pediatric-populations
#18
Philip Kohlmann, Cordula Stillhart, Martin Kuentz, Neil Parrott
Prediction of the pharmacokinetics of orally administered drugs in children is of importance to optimize the efficacy and safety of pediatric medicines. Physiologically based pharmacokinetic (PBPK) models can be helpful for this purpose. However, application of these tools is limited by significant knowledge gaps regarding the physiological and anatomical changes which occur with age. This study aimed at investigating the age-dependent differences in oral absorption of a poorly soluble model compound, carbamazepine (CBZ) in children, infants, and neonates...
October 2, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28969421/polylactide-based-block-co-polymeric-micelles-loaded-with-chlorin-e6-for-photodynamic-therapy-in-vitro-evaluation-in-monolayer-and-3d-spheroid-models
#19
Preeti Kumari, Shreya Jain, Balaram Ghosh, Vladimir Petrovich Zorin, Swati Biswas
Recently, photodynamic therapy (PDT) has found wide application as a non-invasive treatment modality for several cancers. However, the suboptimal delivery of photosensitizers (PSs) to the tumor site is a drawback, which inhibits the effectiveness of PDT. Hydrophobicity, strong oxygen and light dependence, and limited tissue penetrability of photosensitizers represent the major barriers to the clinical application of PDT. In order to improve biopharmaceutical properties of a clinically approved photosensitizer Chlorin e6 (Ce6), we developed a nano-formulation encapsulating Ce6 in methoxy-poly(ethylene glycol)-poly(D,L-lactide) (mPEG-PLA) co-polymeric micelles...
October 2, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28966266/nose-to-brain-delivery-of-peptide-drugs-enhanced-by-coadministration-of-cell-penetrating-peptides-therapeutic-potential-for-dementia
#20
Noriyasu Kamei
 Recent reports suggest that peptide drugs such as insulin have the potential to serve as therapeutics in neurodegenerative diseases such as Alzheimer's disease. However, the transport of these drugs to the therapeutic target, the brain, is significantly hindered by the blood-brain barrier (BBB). Intranasal administration appears to be an ideal solution for drug delivery to the brain, bypassing the BBB, however the entry of peptide drugs into neuronal and epithelial cells in the olfactory mucosa remains low...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
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