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https://www.readbyqxmd.com/read/29221992/active-mediated-transport-of-chloramphenicol-and-thiamphenicol-in-a-calu-3-lung-epithelial-cell-model
#1
S N Nurbaeti, J C Olivier, C Adier, S Marchand, W Couet, J Brillault
Pulmonary administration enables high local concentrations along with limited systemic side-effects, but not all ATB could be good candidates. In this perspective, diffusion of the ATB chloramphenicol (CHL) and thiamphenicol (THA) through the lung has been evaluated to re-assess their potential for pulmonary administration. The apparent permeability (Papp) was evaluated with the Calu-3 cell model. Influence of drug transporters was assessed with the PSC-833, MK-571, and KO-143 inhibitors. The influence of CHL and THA on the cell uptake of rhodamin123 and fluorescein was also evaluated...
December 5, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29220034/just-how-good-an-investment-is-the-biopharmaceutical-sector
#2
Richard T Thakor, Nicholas Anaya, Yuwei Zhang, Christian Vilanilam, Kien Wei Siah, Chi Heem Wong, Andrew W Lo
Uncertainty surrounding the risk and reward of investments in biopharmaceutical companies poses a challenge to those interested in funding such enterprises. Using data on publicly traded stocks, we track the performance of 1,066 biopharmaceutical companies from 1930 to 2015-the most comprehensive financial analysis of this sector to date. Our systematic exploration of methods for distinguishing biotech and pharmaceutical companies yields a dynamic, more accurate classification method. We find that the performance of the biotech sector is highly sensitive to the presence of a few outlier companies, and confirm that nearly all biotech companies are loss-making enterprises, exhibiting high stock volatility...
December 2017: Nature Biotechnology
https://www.readbyqxmd.com/read/29218582/application-of-fluorescence-emission-for-characterization-of-albendazole-and-ricobendazole-micellar-systems-elucidation-of-the-molecular-mechanism-of-drug-solubilization-process
#3
Josefina Priotti, Darío Leonardi, Guillermo Pico, María C Lamas
Albendazole (ABZ) and ricobendazole (RBZ) are referred to as class II compounds in the Biopharmaceutical Classification System. These drugs exhibit poor solubility, which profoundly affects their oral bioavailability. Micellar systems are excellent pharmaceutical tools to enhance solubilization and absorption of poorly soluble compounds. Polysorbate 80 (P80), poloxamer 407 (P407), sodium cholate (Na-C), and sodium deoxycholate (Na-DC) have been selected as surfactants to study the solubilization process of these drugs...
December 7, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/29216805/a-review-on-recent-technologies-for-the-manufacture-of-pulmonary-drugs
#4
Gabriela Daisy Hadiwinoto, Philip Chi Lip Kwok, Richard Lakerveld
This review discusses recent developments in the manufacture of inhalable dry powder formulations. Pulmonary drugs have distinct advantages compared with other drug administration routes. However, requirements of drugs properties complicate the manufacture. Control over crystallization to make particles with the desired properties in a single step is often infeasible, which calls for micronization techniques. Although spray drying produces particles in the desired size range, a stable solid state may not be attainable...
January 2018: Therapeutic Delivery
https://www.readbyqxmd.com/read/29216617/basics-of-sterile-compounding-particulate-matter
#5
Michael J Akers
This article focuses on the requirements for particulate matter in sterile products. Topics include particles and quality, particulate matter standards (large- and small-volume injectables), development of the small-volume injectable test, electronic (light obscuration) and microscope testing, and special requirements for particulate matter in biopharmaceutical preparations.
September 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/29214563/rare-diseases-joining-mainstream-research-and-treatment-based-on-reliable-epidemiological-data
#6
Stephen C Groft, Manuel Posada de la Paz
Despite growing acceptance of patient registries and natural history studies to provide useful information, the rare disease community suffers from the absence of reliable epidemiological data on the prevalence and incidence of most rare diseases in national and global populations. Likewise, the patients and health care providers lack adequate information on the pathophysiology of rare diseases and expected outcomes of these disorders. The rare diseases community includes all of the stakeholders involved in the research and development and dissemination of products and information for the diagnosis, prevention or treatment of rare diseases or conditions...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/29214428/an-invitation-to-pharmacostatics
#7
Gilles Gnacadja
Pharmacology, the study of interactions between biological processes and therapeutic agents, is traditionally presented as consisting of two subdisciplines: pharmacokinetics, which is about the distribution and metabolism of drugs in organisms, and pharmacodynamics, which is about the organisms' response to drugs. In discovery-stage pharmacology however, one primary concern is what we call pharmacostatics, the characterization of equilibrium parameters and states of core interactions of physiologic and therapeutic interest...
December 6, 2017: Bulletin of Mathematical Biology
https://www.readbyqxmd.com/read/29209906/the-fourth-annual-brds-on-genome-editing-and-silencing-for-precision-medicines
#8
Amit Kumar Chaudhary, Rajan Sharma Bhattarai, Ram I Mahato
Precision medicine is promising for treating human diseases, as it focuses on tailoring drugs to a patient's genes, environment, and lifestyle. The need for personalized medicines has opened the doors for turning nucleic acids into therapeutics. Although gene therapy has the potential to treat and cure genetic and acquired diseases, it needs to overcome certain obstacles before creating the overall prescription drugs. Recent advancement in the life science has helped to understand the effective manipulation and delivery of genome-engineering tools better...
December 5, 2017: Drug Delivery and Translational Research
https://www.readbyqxmd.com/read/29209588/efficient-genetic-transformation-of-momordica-charantia-l-by-microprojectile-bombardment
#9
Muralikrishna Narra, Raghu Ellendula, Srinivas Kota, Bharathkumar Kalva, Yashodhara Velivela, Sadanandam Abbagani
Here, we report the optimized conditions for biolistic particle delivery-mediated genetic transformation of bitter melon using petiole segments. In this study, DNA-coated gold particles of 0.6 µm were used for optimizing the parameters of transformation and eventually regeneration of bitter melon putative transgenics. Initially, biolistic parameters namely helium pressure and macrocarrier to target tissue distance, were optimized using binary vector pBI121 carrying both β-glucuronidase gene (GUS) and neomycin phosphotransferase II gene (npt II) as a reporter and as a selectable marker gene, respectively...
January 2018: 3 Biotech
https://www.readbyqxmd.com/read/29205294/wearable-devices-in-clinical-trials-hype-and-hypothesis
#10
Elena S Izmailova, John A Wagner, Eric D Perakslis
The development of innovative wearable technologies has raised great interest in new means of data collection in healthcare and biopharmaceutical research and development. Multiple applications for wearables have been identified in a number of therapeutic areas; however, researchers face many challenges in the clinic, including scientific methodology as well as regulatory, legal, and operational hurdles. To facilitate further evaluation and adoption of these technologies, we highlight methodological and logistical considerations for implementation in clinical trials, including key elements of analytical and clinical validation in the specific context of use (COU)...
December 5, 2017: Clinical Pharmacology and 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
#11
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 5, 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
#12
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 5, 2017: Bioanalysis
https://www.readbyqxmd.com/read/29198837/pareto-optimal-reversed-phase-chromatography-separation-of-three-insulin-variants-with-a-solubility-constraint
#13
Karolina Arkell, Hans-Kristian Knutson, Søren S Frederiksen, Martin P Breil, Bernt Nilsson
With the shift of focus of the regulatory bodies, from fixed process conditions towards flexible ones based on process understanding, model-based optimization is becoming an important tool for process development within the biopharmaceutical industry. In this paper, a multi-objective optimization study of separation of three insulin variants by reversed-phase chromatography (RPC) is presented. The decision variables were the load factor, the concentrations of ethanol and KCl in the eluent, and the cut points for the product pooling...
November 29, 2017: Journal of Chromatography. A
https://www.readbyqxmd.com/read/29198121/industry-academic-collaboration-in-oral-biopharmaceutics-the-european-imi-orbito-project
#14
Mark McAllister, Patricia Zane
No abstract text is available yet for this article.
December 4, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/29197156/identification-of-aggregates-in-therapeutic-formulations-of-recombinant-full-length-factor-viii-products-by-sedimentation-velocity-analytical-ultracentrifugation
#15
J F Healey, E T Parker, P Lollar
BACKGROUND: The development of inhibitory anti-factor VIII (fVIII) antibodies is the most serious complication in the management of patients with hemophilia A. Studies have suggested that recombinant full-length fVIII is more immunogenic than plasma-derived fVIII and that among recombinant fVIII products, Kogenate is more immunogenic than Advate. Aggregates in biopharmaceutical products are considered a risk factor for the development of anti-drug antibodies. OBJECTIVE: To evaluate recombinant full-length fVIII products for the presence of aggregates...
December 2, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/29193870/strain-engineering-to-reduce-acetate-accumulation-during-microaerobic-growth-conditions-in-escherichia-coli
#16
Karthik Veeravalli, Tony Schindler, Emily Dong, Masaki Yamada, Ryan Hamilton, Michael W Laird
Microaerobic (oxygen limited) conditions are advantageous for several industrial applications since a majority of the carbon atoms can be directed for synthesis of desired products. Oxygen limited conditions, however, can result in high levels of undesirable by-products such as acetate which subsequently can have an impact on biomass and product yields. The molecular mechanisms involved in acetate accumulation under oxygen limited conditions are not well understood. Our results indicate that a majority of the genetic modifications known to decrease acetate under aerobic conditions results in similar or even higher acetate under oxygen limitation...
November 30, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/29193824/interactions-between-protein-molecules-and-the-virus-removal-membrane-surface-effects-of-immunoglobulin-g-adsorption-and-conformational-changes-on-filter-performance
#17
Ryo Hamamoto, Hidemi Ito, Makoto Hirohara, Ryongsok Chang, Tomoko Hongo-Hirasaki, Tomohiro Hayashi
Membrane fouling commonly occurs in all filter types during virus filtration in protein-based biopharmaceutical manufacturing. Mechanisms of decline in virus filter performance due to membrane fouling were investigated using a cellulose-based virus filter as a model membrane. Filter performance was critically dependent on solution conditions; specifically, ionic strength. To understand the interaction between immunoglobulin G (IgG) and cellulose, sensors coated with cellulose were fabricated for surface plasmon resonance and quartz crystal microbalance with energy dissipation measurements...
November 29, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/29193077/evaluating-bioequivalence-of-meloxicam-tablets-is-in-vitro-dissolution-test-overdiscriminating
#18
Chan Jin, Chenyao Zhao, Dachao Shen, Wenxiang Dong, Hongzhuo Liu, Zhonggui He
OBJECTIVES: The aim of the study was to assess the impact of the differences in dissolution profiles of meloxicam tablets on the in-vivo bioavailability parameters after oral administration. METHODS: Compare in-vitro dissolution testing in the recommended media to evaluate in-vivo bioequivalence outcomes for the Biopharmaceutics Classification System Class II weak acidic drugs. Nine Beagle dogs received a single oral administration of each formulation (7.5 mg) in a three-way crossover design...
November 28, 2017: Journal of Pharmacy and Pharmacology
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
#19
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
https://www.readbyqxmd.com/read/29190474/functional-micrococcus-lysodeikticus-layers-deposited-by-laser-technique-for-the-optical-sensing-of-lysozyme
#20
Valentina Dinca, Diana Zaharie-Butucel, Luciana Stanica, Simona Brajnicov, Valentina Marascu, Anca Bonciu, Andra Cristocea, Laura Gaman, Mihaela Gheorghiu, Simion Astilean, Alina Vasilescu
Whole cell optical biosensors, made by immobilizing whole algal, bacterial or mammalian cells on various supports have found applications in several fields, from ecology and ecotoxicity testing to biopharmaceutical production or medical diagnostics. We hereby report the deposition of functional bacterial layers of Micrococcus lysodeikticus (ML) via Matrix-Assisted Pulsed Laser Evaporation (MAPLE) on poly(diallyldimethylamonium) (PDDA)-coated-glass slides and their application as an optical biosensor for the detection of lysozyme in serum...
November 23, 2017: Colloids and Surfaces. B, Biointerfaces
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