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John F Kellie, Jonathan R Kehler, Thomas J Mencken, Richard J Snell, Charles S Hottenstein
AIM: Large-molecule biotherapeutic quantitation in vivo by LC-MS has traditionally relied on enzymatic digestion followed by quantitation of a 'surrogate peptide' to infer whole-molecule concentration. MS methods presented here measure the whole molecule and provide a platform to better understand the various circulating drug forms by allowing for variant quantitation. RESULTS: An immunocapture LC-MS method for quantitation of a biotherapeutic monoclonal antibody from human plasma is presented...
October 2016: Bioanalysis
Labe A Black, Celestine J Thomas, Gwendolyn N Nix, Michelle C Terwilliger, Stephen R Sprang, J B Alexander Ross
Resistance to Inhibitors of Cholinesterase A (Ric-8A) is a 60-kDa cytosolic protein that has chaperone and guanine nucleotide exchange (GEF) activity toward heterotrimeric G protein α subunits of the i, q, and 12/13 classes, catalyzing the release of GDP from Gα and subsequent binding of GTP. In the absence of GTP or GTP analogs, and subsequent to GDP release, Gα forms a stable nucleotide-free complex with Ric-8A. In this study, time-resolved fluorescence anisotropy measurements were employed to detect local motions of Gαi1 labeled at selected sites with Alexa 488 (C5) fluorescent dye (Ax) in the GDP, GTPγS (collectively, GXP), and Ric-8A-bound states...
August 23, 2016: Biophysical Journal
Bob Buhlmann, Madlene Dole, Zena Kaufmann
No abstract text is available yet for this article.
September 2016: PDA Journal of Pharmaceutical Science and Technology
Yashpal Singh Malik, Naveen Kumar, Kuldeep Sharma, Sharad Saurabh, Kuldeep Dhama, Minakshi Prasad, Souvik Ghosh, Krisztián Bányai, Nobumichi Kobayashi, Raj Kumar Singh
Rotavirus-A (RVAs), are the major cause of severe gastroenteritis in the young of mammals and birds. RVA strains possessing G6, G8, and G10 genotypes in combination with P[1] or P[11] have been commonly detected in cattle. During a routine surveillance for enteric viruses in a bovine population on North-Western temperate Himalayan region of India, an uncommon bovine RVA strain, designated as RVA/Cow-wt/IND/M1/09/2009 was detected in a diarrhoeic crossbred calf. The examination of nearly complete genome sequence of this RVA strain revealed an unusual G-P combination (G3P[11]) on a typical bovine RVA genotype backbone (I2-R2-C2-M2-A11-N2-T6-E2-H3)...
July 2016: Infection, Genetics and Evolution
Jennifer J Hull, Douglas Marthaler, Stephanie Rossow, Terry Fei Fan Ng, Anna M Montmayeur, Laura Magana, Sung-Sil Moon, Baoming Jiang
The genomic sequence of a rotavirus group H was identified in the intestine of a diarrheal pig in the United States, designated RVH/Pig-wt/USA/MN9.65/2008/GxP[x].
2016: Genome Announcements
Patricia Schöppner, Gergely Csaba, Tatjana Braun, Marina Daake, Bettina Richter, Oliver F Lange, Martin Zacharias, Ralf Zimmer, Martin Haslbeck
Alternative splicing often affects structured and highly conserved regions of proteins, generating so called non-trivial splicing variants of unknown structure and cellular function. The human small G-protein Rab1A is involved in the regulation of the vesicle transfer from the ER to Golgi. A conserved non-trivial splice variant lacks nearly 40% of the sequence of the native Rab1A, including most of the regulatory interaction sites. We show that this variant of Rab1A represents a stable and folded protein, which is still able to bind nucleotides and co-localizes with membranes...
April 24, 2016: Journal of Molecular Biology
Nader Shafiei, Regis De Montardy, Edwin Rivera-Martinez
In reaction to breaches of data integrity in the pharmaceutical industry, regulatory authorities have introduced inspection approaches or initiatives with the aim of reducing occurrences of data integrity problems. This review article-based on study of 65 cases of regulatory action from 2002 to 2014-provides an overview of current regulatory thinking and action on breaches of data integrity affecting GxP (health-related regulations) processes supporting non-clinical studies, clinical studies, laboratory controls, and production controls...
November 2015: PDA Journal of Pharmaceutical Science and Technology
Paula F Sperlich, Hans-Christer Holmberg, Jennifer L Reed, Christoph Zinner, Joachim Mester, Billy Sperlich
The purpose of this study was to determine whether an individually designed incremental exercise protocol results in greater rates of oxygen uptake (VO2max) than standardized testing. Fourteen well-trained, male runners performed five incremental protocols in randomized order to measure their VO2max: i) an incremental test (INCS+I) with pre-defined increases in speed (2 min at 8.64 km·h(-1), then a rise of 1.44 km·h(-1) every 30 s up to 14.4 km·h(-1)) and thereafter inclination (0.5° every 30 s); ii) an incremental test (INCI) at constant speed (14...
June 2015: Journal of Sports Science & Medicine
Nazir A Ismail, Shaheed V Omar, James J Lewis, David W Dowdy, Andries W Dreyer, Hermina van der Meulen, George Nconjana, David A Clark, Gavin J Churchyard
RATIONALE: TBDx automated microscopy is a novel technology that processes digital microscopic images to identify acid-fast bacilli (AFB). Use of TBDx as part of a diagnostic algorithm could improve the diagnosis of tuberculosis (TB), but its performance characteristics have not yet been formally tested. OBJECTIVES: To evaluate the performance of the TBDx automated microscopy system in algorithms for diagnosis of TB. METHODS: Prospective samples from patients with presumed TB were processed in parallel with conventional smear microscopy, TBDx microscopy, and liquid culture...
June 15, 2015: American Journal of Respiratory and Critical Care Medicine
Jitendra Maharana, Bikash Ranjan Sahoo, Aritra Bej, Itishree Jena, Arunima Parida, Jyoti Ranjan Sahoo, Budheswar Dehury, Mahesh Chandra Patra, Sushma Rani Martha, Sucharita Balabantray, Sukanta Kumar Pradhan, Bijay Kumar Behera
Nucleotide-binding oligomerization domain-containing protein 1 (NOD1) and NOD2 are cytosolic pattern recognition receptors playing pivotal roles in innate immune signaling. NOD1 and NOD2 recognize bacterial peptidoglycan derivatives iE-DAP and MDP, respectively and undergoes conformational alternation and ATP-dependent self-oligomerization of NACHT domain followed by downstream signaling. Lack of structural adequacy of NACHT domain confines our understanding about the NOD-mediated signaling mechanism. Here, we predicted the structure of NACHT domain of both NOD1 and NOD2 from model organism zebrafish (Danio rerio) using computational methods...
2015: PloS One
Luis Fernando López Tort, Matías Victoria, Andrés Lizasoain A, Matías Castells, Leticia Maya, Mariela Martínez Gómez, Edit Arreseigor, Patricia López, Juan Cristina, Jose Paulo Gagliardi Leite, Rodney Colina
Group A rotavirus (RVA) is the most important etiologic agent of infant acute gastroenteritis (AGE) worldwide. Detection and molecular characterization of RVA in Salto department, Northwestern region of Uruguay, was conducted on 175 clinical samples, being 153 stool and 22 vomit samples, collected from hospitalized children with AGE, between 0-15 years old, from two hospitals of Salto city during 2011 and 2012. RVA was detected and genotyped by seminested multiplex RT-PCR in order to determine G- and P-genotypes...
May 2015: Journal of Medical Virology
Jennifer Benner
Pharmaceutical research and development has entered a new era, shifting from the one-size-fits-all approach of traditional medicine to patient-specific therapeutics. This change in treatment methodologies has placed an increased emphasis on well-preserved, well-documented biospecimens. Due to these advancements in medicine, specimen handling processes need to be in accordance with current Good Practice (GXP) quality guidelines and regulations, including Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs), to ensure the safety of valuable biospecimen samples and their associated data...
September 2009: Biopreservation and Biobanking
N Novakovic, T Todorovic, M Rakic, I Milinkovic, I Dozic, S Jankovic, Z Aleksic, S Cakic
BACKGROUND AND OBJECTIVE: One of the major pathologic patterns in periodontitis represents an imbalance among the production of free radicals and local antioxidants resulting in periodontal tissue destruction. The objective of the study was to investigate the influence of non-surgical periodontal treatment on salivary antioxidants and to evaluate their capacity as biomarkers reflecting periodontal tissue condition and therapy outcome. MATERIAL AND METHODS: Sixty-three systemically healthy non-smokers, including 21 periodontally healthy subjects (HC) and 42 patients with current chronic periodontitis fulfilled the inclusion criteria...
February 2014: Journal of Periodontal Research
Stephan Rönninger, Siegfried Schmitt, Vijaya Rangavajhula, Emily Hough, Jim Lyda
The purpose of this article is to summarize the current GxP standards which need to be applied by global pharmaceutical manufacturers in order to achieve compliance with global regulatory requirements. Companies need to follow and audit against relevant global/regional and domestic laws as well as focusing on the lifecycle aspects of the product and processes involved from development through to routine commercial manufacture. This article was written under the auspices of PDA's Paradigm Change for Manufacturing Operations (PCMO(SM)) task force on risk-based auditing...
September 2012: PDA Journal of Pharmaceutical Science and Technology
Carolina Tropini, Elizabeth A Roth, Marija Zanic, Melissa K Gardner, Jonathon Howard
Microtubules are dynamic polymers of GTP- and GDP-tubulin that undergo stochastic transitions between growing and shrinking phases. Rescues, the conversion from shrinking to growing, have recently been proposed to be to the result of regrowth at GTP-tubulin islands within the lattice of growing microtubules. By introducing mixed GTP/GDP/GMPCPP (GXP) regions within the lattice of dynamic microtubules, we reconstituted GXP islands in vitro (GMPCPP is the slowly hydrolyzable GTP analog guanosine-5'-[(α,β)-methyleno]triphosphate)...
2012: PloS One
Patrizia Popoli, Maria Francesca Cometa, Fulvia Fabi, Annarita Meneguz
Advanced therapy medicinal products (ATMP) can offer new, effective therapeutic options for the treatment of severe illnesses, including cancer, neurodegenerative and cardiovascular diseases. Translation of advanced therapies to the clinic has been slow despite significant academic research from academia and foundations. The implementation of 2001/20 Directive in Italy established that the development of an ATMP should follow the GXP rules - good manufacturing practice (GMP) for production, good laboratory practice (GLP) for non clinical safety studies and good clinical practice (GCP) for clinical trials...
2011: Annali Dell'Istituto Superiore di Sanità
Frank Chambers, Aziz Ali, Jolyon Mitchell, Christopher Shelton, Steve Nichols
Multi-stage cascade impactors (CIs) are the preferred measurement technique for characterizing the aerodynamic particle size distribution of an inhalable aerosol. Stage mensuration is the recommended pharmacopeial method for monitoring CI "fitness for purpose" within a GxP environment. The Impactor Sub-Team of the European Pharmaceutical Aerosol Group has undertaken an inter-laboratory study to assess both the precision and accuracy of a range of makes and models of instruments currently used for optical inspection of impactor stages...
March 2010: AAPS PharmSciTech
Darryl P Arfsten, Eric W Johnson, Erin R Wilfong, Anne E Jung, Andrew J Bobb
The distribution of radio-labeled N-Acetyl-L-Cysteine (NAC) and its impact on glutathione (GSH) metabolism was studied in Sprague-Dawley rats following single and multiple dosing with NAC by oral gavage. Radioactivity associated with administration of (14)C-NAC distributed to most tissues examined within 1 hour of administration with peak radioactivity levels occurring within 1 hour to 4 hours and for a majority of the tissues examined, radioactivity remained elevated for up to 12 hours or more. Administration of a second dose of 1,200 mg/kg NAC + (14)C-NAC 4 hours after the first increased liver, kidney, skin, thymus, spleen, eye, and serum radioactivity significantly beyond levels achieved following 1 dose...
2007: Cutaneous and Ocular Toxicology
Detlef D Leipe, Eugene V Koonin, L Aravind
Using sequence profile analysis and sequence-based structure predictions, we define a previously unrecognized, widespread class of P-loop NTPases. The signal transduction ATPases with numerous domains (STAND) class includes the AP-ATPases (animal apoptosis regulators CED4/Apaf-1, plant disease resistance proteins, and bacterial AfsR-like transcription regulators) and NACHT NTPases (e.g. NAIP, TLP1, Het-E-1) that have been studied extensively in the context of apoptosis, pathogen response in animals and plants, and transcriptional regulation in bacteria...
October 8, 2004: Journal of Molecular Biology
M Patthy, G Seres, A Csanádi, T Szekeres, Z Zubovics, N Bodor
Etiprednol dicloacetate (ethyl 17alpha-dichloroacetoxy-11beta-hydroxy-androsta-1,4-diene-3-one-17beta-carboxylate, code-named: BNP-166) has been prepared in a 3-step synthesis from prednisolone as starting material. The primary aim of the present work was to develop HPLC methods for the separation of all the impurities found in experimental pilot plant batches of BNP-166 at concentrations > or = 0.10 area %. Besides BNP-166, a total of 19 compounds, eight of them potential impurities, were involved in the HPLC studies in which several HPLC systems were examined and tested to optimize the separation...
May 2004: Die Pharmazie
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