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William F Weiss, John P Gabrielson, Wasfi Al-Azzam, Guodong Chen, Darryl L Davis, Tapan K Das, David B Hayes, Damian Houde, Satish K Singh
Characterization of the higher order structure (HOS) of protein-based biopharmaceutical products is an important aspect of their development. Opinions vary about how best to apply biophysical methods, in which contexts to use these methods, and how to use the resulting data to make technical decisions as drug candidates are commercialized [Gabrielson JP, Weiss WF IV. J Pharm Sci. 2015;104(4):1240-1245]. The aim of this commentary is to provide guidance for the development and implementation of a robust and comprehensive HOS characterization strategy...
October 12, 2016: Journal of Pharmaceutical Sciences
Bernadett Berecz Berecz, Helga Zelenyánszki, Sára Pólya, Cecília Tamás-Nyitrai, Mária Oszvald
Vaccines produced in plants have opened up new opportunities in vaccination. Among the various categories of vaccines, the recombinant vaccine is generally regarded as the most economical and safest type because it cannot cause disease and does not require large-scale cultivation of pathogens. Due to the low cost of their cultivation, plants may represent viable alternative platforms for producing subunit vaccines. Genetic engineering of plastids is the innovation of the last three decades and has numerous benefits when compared to nuclear transformation...
October 4, 2016: Mini Reviews in Medicinal Chemistry
Henrik Aronsson, Petter Larsson, Sandra Bains
Higher plants have been used in medicine throughout human history. While traditional medicinal uses relied on compounds produced naturally by plants, recent advances have enabled the use of plant-based factories to produce diverse agents including pharmaceuticals, antibiotics, and vaccines. The genes responsible for the production of these substances can be either transiently expressed in plants or integrated into their nuclear genome or plastid genome (plastome) by genetic transformation. This review focuses on the application of plastid transformation of higher plants to produce biopharmaceuticals for human applications that are neither antibiotics nor vaccines...
October 4, 2016: Mini Reviews in Medicinal Chemistry
Krm Ferrier, C E van Elk, P E Bunskoek, Mph van den Broek
Bottlenose dolphins (Tursiops truncatus) can suffer from fungal infections, which can be treated with voriconazole. In common practice, the voriconazole doses are extrapolated from human doses by adjusting for body weight only, because no dose regimen is available yet. Therefore, the aim of this study was to define a dose regimen for voriconazole in bottlenose dolphins. Dolphins treated with voriconazole between November 2005 and September 2015 at the Dolfinarium Harderwijk, the Netherlands, and TDM was performed were included...
October 4, 2016: Medical Mycology: Official Publication of the International Society for Human and Animal Mycology
Andrea Di Guardo, Antonio Finizio
Analogously to the evolution of the EU legislation on pesticides, there is an increasing need of strategies aiming to reach a "sustainable use of veterinary pharmaceuticals". To this end, it is essential to develop tools, such as supporting information systems (SIS), for managing the environmental risks of veterinary pharmaceuticals on a territorial scale. In this context, we propose Sust-PHarm (SUSTainable use of veterinary Pharmaceuticals), a SIS useful to identify groundwater vulnerable areas to veterinary pharmaceuticals at both local and regional scale...
September 30, 2016: Science of the Total Environment
Iqbal Ahmad, Adeel Arsalan, Syed Abid Ali, Raheela Bano, Iqra Munir, Arif Sabah
No abstract text is available yet for this article.
October 10, 2016: European Journal of Pharmaceutical Sciences
Paul A Dickinson, Filippos Kesisoglou, Talia Flanagan, Marilyn N Martinez, Hitesh B Mistry, John R Crison, James E Polli, Maria T Cruañes, Abu T M Serajuddin, Anette Müllertz, Jack A Cook, Arzu Selen
The aim of Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid is to facilitate optimization of clinical performance of drug products. BioRAM strategy relies on therapy-driven drug delivery and follows an integrated systems approach for formulating and addressing critical questions and decision-making (J Pharm Sci. 2014,103(11): 3777-97). In BioRAM, risk is defined as not achieving the intended in vivo drug product performance, and success is assessed by time to decision-making and action...
November 2016: Journal of Pharmaceutical Sciences
Jamal Shamsara
BACKGROUND: Cross-docking is an approach to find the best holo structures among multiple structures available for a target protein. RESULTS: CrossDocker significantly decreases the time needed for setting parameters and inputs for performing multiple dockings, data collection and subsequent analysis. CONCLUSION: CrossDocker was written in Python language and is available as executable binary for Windows operating system. It is available at http://www...
2016: SpringerPlus
Shivangi Naik, Raj Mukherjee, Bodhisattwa Chaudhuri
No abstract text is available yet for this article.
October 15, 2016: International Journal of Pharmaceutics
Gina Webster, Audrey Y-H Teh, Julian K-C Ma
Degeneracy in the genetic code allows multiple codon sequences to encode the same protein. Codon usage bias in genes is the term given to the preferred use of particular synonymous codons. Synonymous codon substitutions had been regarded as "silent" as the primary structure of the protein was not affected; however, it is now accepted that synonymous substitutions can have a significant effect on heterologous protein expression. Codon optimization, the process of altering codons within the gene sequence to improve recombinant protein expression, has become widely practised...
September 12, 2016: Biotechnology and Bioengineering
Jaime I Arevalo-Villalobos, Sergio Rosales-Mendoza, Sergio Zarazua
INTRODUCTION: Neurodegenerative diseases (NDs) have a serious impact on global health with no effective treatments available to date. Vaccination has been proposed as a therapeutic approach for NDs, and clinical evaluations of some candidates for Alzheimer's disease and multiple sclerosis are ongoing. Moreover, monoclonal antibodies for passive immunotherapy are under evaluation for Alzheimer's, synucleinopathies, and multiple sclerosis. AREAS COVERED: With the consolidation of plant-based systems for the production and oral delivery of biopharmaceuticals, interesting perspectives arise in the fight against NDs...
August 31, 2016: Expert Review of Vaccines
Patrick J Lindsay, Stuart E Bond, Dip Pharm Prac, Ross Norris, Deborah Je Marriott, Spiros Miyakis
BACKGROUND: Posaconazole therapeutic drug monitoring (TDM) is recommended to promote effective antifungal prophylaxis, but its utility has yet to be optimized. Breakthrough invasive fungal infections have been reported with serum concentrations <700 μg/L, but there is little evidence to determine the optimal serum concentration for efficacy or concentrations associated with toxicity. Challenges for effective monitoring are greater in settings without posaconazole TDM facilities due to the long turnaround time prior to receipt of results...
August 19, 2016: Therapeutic Drug Monitoring
Ariana Low, Si Ling Kok, Yuetmei Khong, Sui Yung Chan, Rajeev Gokhale
No standard time or pharmacopoeia disintegration test method for orodispersible films (ODFs) exists. The USP disintegration test for tablets and capsules poses significant challenges for end-point determination when used for ODFs. We tested a newly developed disintegration test unit (DTU) against the USP disintegration test. The DTU is an accessory to the USP disintegration apparatus. It holds the ODF in a horizontal position, allowing top-view of the ODF during testing. A Gauge R&R study was conducted to assign relative contributions of the total variability from the operator, sample or the experimental set-up...
November 2015: Journal of Pharmaceutical Sciences
Leandro Gonzaga De Oliveira, Letîcia Aparecida Figueiredo, Gabriella Maria Fernandes-Cunha, De Miranda Marina Barcelos, Laser Antonio Machado, Gisele Rodrigues Dasilva, De Moura Sandra Aparecida Lima
In this study, the methotrexate (MTX) was incorporated into the poly(e-caprolactone) (PCL) to design implants (MTX PCL implants) aiming the local treatment of inflammatory angiogenesis diseases without causing systemic side effects. Sponges were inserted into the subcutaneous tissue of mice as a framework for fibrovascular tissue growth. After 4days, MTX PCL implants were also introduced, and anti-inflammatory, antiangiogenic, and antifibrogenic activities of the MTX were determined. MTX reduced the vascularization (hemoglobin content), the neutrophil, and monocyte/macrophage infiltration (MPO and NAG activities, respectively), and the collagen deposition in sponges...
November 2015: Journal of Pharmaceutical Sciences
Michel Girard, Anita Kane, Sylvie Boucher
Capillary electrophoresis (CE) comprises several separation modes that can be used to characterize proteins in terms of physico-chemical properties such as isoelectric point or molecular weight, or in terms of purity/heterogeneity for the presence of charge or size variants. In glycoproteins the heterogeneity occurring as a consequence of variable amounts of terminal sialic acid residues on glycan moieties can be detected by CE. As such, a capillary zone electrophoresis (CZE) method was found suitable for the detection of isoforms of several erythropoiesis-stimulating agents (Bietlot and Girard, J Chromatogr A 759:177-184, 1997; Boucher et al...
2016: Methods in Molecular Biology
Sen-Ling Feng, Zhong-Wen Yuan, Xiao-Jun Yao, Wen-Zhe Ma, Liang Liu, Zhong-Qiu Liu, Ying Xie
No abstract text is available yet for this article.
July 25, 2016: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
Shlomit Dachir, Izhak Barness, Eliezer Fishbine, Jacob Meshulam, Rita Sahar, Arik Eisenkraft, Adina Amir, Tamar Kadar
Prevention of the penetration of toxic agents through the skin is crucial for both military troops and civilian populations. We have developed a novel topical skin protectant (TSP), coded as IB1 and commercially available as Dermostyx protective solution (Rekah Pharm, Israel). The formulation afforded significant protection against chemical warfare agents such as sulfur mustard (SM) and VX (2LD50), pesticides such as parathion and irritants such as acrolein. The efficacy of the protectant was evaluated in the pig model using clinical, histological and biochemical monitoring...
July 11, 2016: Chemico-biological Interactions
Miray Tonk, Andreas Vilcinskas
Antimicrobial peptides (AMPs) are peptide-based effector molecules produced by the innate immune system to combat microbes. Insects produce the broadest repertoire of AMPs, and their potent antimicrobial activity in vitro and in vivo has promoted their development as alternatives to conventional antibiotics, in an attempt to address the threat of multidrug-resistant pathogens. Here we discuss current obstacles that hinder the therapeutic development of novel insect-derived AMPs, including potential cytotoxic, immunogenic and allergenic side effects, and the high costs of large-scale production...
July 13, 2016: Current Topics in Medicinal Chemistry
Andrew D Rouillard, Gregory W Gundersen, Nicolas F Fernandez, Zichen Wang, Caroline D Monteiro, Michael G McDermott, Avi Ma'ayan
Genomics, epigenomics, transcriptomics, proteomics and metabolomics efforts rapidly generate a plethora of data on the activity and levels of biomolecules within mammalian cells. At the same time, curation projects that organize knowledge from the biomedical literature into online databases are expanding. Hence, there is a wealth of information about genes, proteins and their associations, with an urgent need for data integration to achieve better knowledge extraction and data reuse. For this purpose, we developed the Harmonizome: a collection of processed datasets gathered to serve and mine knowledge about genes and proteins from over 70 major online resources...
2016: Database: the Journal of Biological Databases and Curation
Naomi Lee
No abstract text is available yet for this article.
June 18, 2016: Lancet
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