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Biologicals: Journal of the International Association of Biological Standardization

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https://www.readbyqxmd.com/read/28522247/potential-of-multi-component-antigens-for-tuberculosis-diagnosis
#1
Sana Khurshid, Madeeha Afzal, Ruqqya Khalid, M Waheed Akhtar, Mahmood Husain Qazi
Tuberculosis is one of the top ten causes of deaths worldwide. The cause of tuberculosis is a bacterium, Mycobacterium tuberculosis, which has been surviving for centuries. Immunological tests based on detecting the presence of antibodies in the sera of active TB patients against various antigens of M. tuberculosis are useful for diagnosis of TB and offer simple, rapid and cost effective methods most suitable for poor and developing countries. Several recombinant antigens have been reported so far with varying sensitivity individually, yet none had shown sensitivity higher enough to be used in a commercial test...
May 15, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28495312/considerations-of-critical-quality-attributes-in-the-analytical-comparability-assessment-of-biosimilar-products
#2
Ohseok Kwon, Jeewon Joung, Younjoo Park, Chan Wha Kim, Seung Hwa Hong
Based on experience in clinical trial approvals and marketing authorizations for biosimilar products in Korea, we suggest principles for the analytical comparability assessment of biosimilar products with respect to regulatory considerations. The composition and manufacturing processes of biosimilar products can differ from those of the reference product depending on the information available for the reference product and the time of product development; however, the analytical characteristics of biosimilar products should be highly similar to those of the reference product...
May 8, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28483511/collagen-alginate-microspheres-as-a-3d-culture-system-for-mouse-embryonic-stem-cells-differentiation-to-primordial-germ-cells
#3
Vahid Mansouri, Mohammad Salehi, Mir Davood Omrani, Zahra Niknam, Abdolreza Ardeshirylajimi
Germ cells differentiation of stem cells will aid treatment of adults with infertility. Biopolymers utilization provided synthetic extracellular matrix (ECM) and desired attributes in in vitro to improve conditions for stem cells attachment, proliferation and differentiation. Mixture of alginate as a biocompatible hydrogel, with collagen IV, could establish an in vitro 3 dimensional (3D) culture model. The objective of this study was investigation of the mouse ESCs differentiation capacity to putative primordial germ cells (PGCs) in the alginate and alginate-collagen IV microspheres (CAM)...
May 5, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28456444/creation-of-a-bovine-herpes-virus-1-bohv-1-quantitative-particle-standard-by-transmission-electron-microscopy-and-comparison-with-established-standards-for-use-in-real-time-pcr
#4
Marc Hoferer, Anne Braun, Reinhard Sting
Standards are pivotal for pathogen quantification by real-time PCR (qPCR); however, the creation of a complete and universally applicable virus particle standard is challenging. In the present study a procedure based on purification of bovine herpes virus type 1 (BoHV-1) and subsequent quantification by transmission electron microscopy (TEM) is described. Accompanying quantitative quality controls of the TEM preparation procedure using qPCR yielded recovery rates of more than 95% of the BoHV-1 virus particles on the grid used for virus counting, which was attributed to pre-treatment of the grid with 5% bovine albumin...
April 26, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28427828/a-combined-clostridium-perfringens-trueperella-pyogenes-inactivated-vaccine-induces-complete-immunoprotection-in-a-mouse-model
#5
Wenlong Zhang, Pu Wang, Bing Wang, Bo Ma, Junwei Wang
Clostridium perfringens (C. perfringens) and Trueperella pyogenes (T. pyogenes) are two bacterial pathogens frequently associated with wound infections and following lethal complications in livestock. However, prudent use of antimicrobial agents is highly required given the emergence of multidrug-resistant strains of both bacteria and need for food safety. In the current study, a combined vaccine, composed of inactivated C. perfringens and T. pyogenes, was prepared. The amount of formaldehyde being used to inactivate two bacteria was optimized to retain the immunogenicity of antigens...
April 17, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28404459/preparation-of-pseudomonas-aeruginosa-alginate-flagellin-immunoconjugate
#6
Sobhan Faezi, Ahmad Reza Bahrmand, Mehdi Mahdavi, Seyed Davar Siadat, Soroush Sardari, Iraj Nikokar, Korosh Khanaki, Ebrahim Mirzajani, Gholamreza Goudarzi
Mucoid strains of Pseudomonas aeruginosa are closely associated with chronic pulmonary infections. In this report we describe a straightforward approach to conjugate high molecular weight alginate to type b-flagellin (FLB) and investigation of its bioactivity. The conjugation process was performed by using ADH and EDAC. The endotoxin was eliminated from the candidate vaccine by LPS removal resin followed by LAL test. The bioconjugate molecules were verified by simultaneously determination of polysaccharide/protein content followed by gel filtration chromatography and FTIR spectroscopy...
April 10, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28400083/proposal-for-an-anti-tnf-exit-strategy-based-on-trough-serum-level
#7
Ulf Helwig, Frederik Lutter, Nadine Koppka, Stefan Schreiber
BACKGROUND AND AIMS: The aim of the study was to evaluate, if the strategy to stop anti-TNF treatment after determination of low trough serum levels and exclusion of inflammation is associated with lower relapse rates. METHODS: Since 2013 we followed an exit strategy in patients treated with anti-TNF treatment for inflammatory bowel disease based on trough serum levels. The relapse rates were observed prospectively, data analysis was performed in a retrospective manner of the collected clinical data...
April 8, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28389173/evaluation-of-the-ph-eur-anti-a-and-anti-b-assay-on-a-pipetting-robot-in-combination-with-a-camera-guided-reading-mode
#8
G J Hausammann, C L Bellac, M Sänger, M Gilgen
The main objective of this study was the standardization of the direct anti-A, anti-B haemagglutination assay for immunoglobulin products in microtitre plates and gelcards by automation on a liquid handling robot. In addition, the evaluation of the pipetted microtitre plates with a computer-controlled camera was investigated and these results were related to titres from visual live reading. The titres obtained with the automated and the manual assay in microtitre plates and gelcards were compared. They were in excellent agreement: the titres of samples processed with the automated method varied maximally one titre step relative to the median titres of the same sample analysed with the manual method...
April 4, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28389172/evaluation-of-candidate-international-standards-for-meningococcal-serogroups-a-and-x-polysaccharide
#9
Caroline Vipond, Carolyn J Swann, Thomas W Dougall, Peter Rigsby, Fang Gao, Nicola J Beresford, Barbara Bolgiano
Polysaccharide (PS) based meningococcal vaccines are primarily evaluated by physicochemical methods to ensure batches are consistently manufactured. As PS content is determined by different methods across numerous laboratories, there is a need for International Standards (IS) to calibrate the assays. Following the successful introduction of the WHO Meningococcal group C (MenC) IS in 2011, NIBSC initiated projects to prepare similar standards for groups A, W, Y and X (MenA/W/Y/X) to standardise all meningococcal- PS based vaccines...
April 4, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28377078/pathogen-safety-and-characterisation-of-a-highly-purified-human-alpha1-proteinase-inhibitor-preparation
#10
Scott Kee, David Weber, Birgit Popp, Thomas Nowak, Wolfram Schäfer, Albrecht Gröner, Nathan J Roth
Alpha1-proteinase inhibitor (A1PI) deficiency is a genetic condition predisposing to emphysema. Respreeza/Zemaira, a therapeutic preparation of A1PI, is prepared from human plasma. This article describes the purity and stability of Respreeza/Zemaira and the capacity of virus and prion reduction steps incorporated into its manufacturing process. Purity and stability of Respreeza/Zemaira were analysed using established methods. To test pathogen clearance capacity, high levels of test viruses/prions were spiked into aliquots of production intermediates and clearance studies were performed for selected manufacturing steps, under production and robustness conditions, using validated scale-down models...
April 1, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28366627/metagenomic-assessment-of-adventitious-viruses-in-commercial-bovine-sera
#11
Kathy Toohey-Kurth, Samuel D Sibley, Tony L Goldberg
Animal serum is an essential supplement for cell culture media. Contamination of animal serum with adventitious viruses has led to major regulatory action and product recalls. We used metagenomic methods to detect and characterize viral contaminants in 26 bovine serum samples from 12 manufacturers. Across samples, we detected sequences with homology to 20 viruses at depths of up to 50,000 viral reads per million. The viruses detected represented nine viral families plus four taxonomically unassigned viruses and had both RNA genomes and DNA genomes...
March 30, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28359595/shelf-life-of-diluted-human-interferon-%C3%AE-for-veterinary-clinical-use
#12
Massimo Amadori, Giovanni Fiorentini
BACKGROUND: Oral, low-dose, human interferon (IFN)-α treatments have shown efficacy in different models of viral and autoimmune diseases. Human IFN-α is commonly used at a daily dose between 1 and 10 IU/kg body weight. Registered products matching these doses at convenient concentrations are lacking. AIM: The stability of sterile, diluted, human leukocyte IFN-α was investigated under cold-chain and room temperature conditions. RESULTS: Diluted IFN-α displayed moderate decay at room temperature (20-23 °C), which should restrict the shelf life to 3-4 days after compounding...
March 27, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28347631/the-first-serological-investigation-of-chicken-astrovirus-infection-in-china
#13
Jia Xue, Tao Han, Meiyu Xu, Jing Zhao, Guozhong Zhang
Chicken astrovirus (CAstV) is associated with 'white chick' syndrome, which increases embryo mortality and reduces hatchability in chickens. In the present study, 1760 sera were collected from 21 provinces in China to detect antibodies directed against CAstV with an ELISA. The sera were from different varieties of chicken in 85 flocks and all the flocks produced positive reactions. The overall seroprevalence in the birds tested was 60.68%. The prevalence increased from 34.17% to 74.44% with the increase of age...
March 24, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28284570/enzyme-antibody-dual-film-modified-gold-nanoparticle-probe-for-ultrasensitive-detection-of-alpha-fetoprotein
#14
Qian Xiao, Yizhi Zheng, Jing Liu, Suiping Wang, Bo Feng
In this study, we designed a comprehensive strategy for the ultrasensitive detection of alpha fetoprotein (AFP) with high specificity using gold nanoparticle (AuNP)-based enzyme-linked immunosorbent assay (ELISA). A dual-film modified probe was synthesized by coating AuNPs with horseradish peroxidase (HRP) on its surface. Anti-AFP monoclonal antibody (McAb) was immobilized on the surface of the enzyme using glutaraldehyde cross-linking method. AuNPs, employed as support for the immobilization of HRP. HRP was used not only as the enzymatic-amplified tracer but also as a bridge for loading McAb...
March 8, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28262479/the-impact-of-oxidative-dna-changes-and-atm-expression-on-morphological-and-functional-activities-on-hepatocytes-obtained-from-mesenchymal-stem-cells
#15
Shahnaz Esmaeli, Abdolamir Allameh, Maryam Adelipour, Masoud Soleimani, Mina Allameh
Resistance to oxidative damages in undifferentiated mesenchymal stem cells (MSCs) in comparison with the undifferentiated progenitor cells may differ depending on several factors. This study was carried out to examine the impact of hepatogenic differentiation process of MSCs on oxidative DNA damage markers. Hepatic differentiation of MSCs was carried out using a two-step conventional protocol and the cells were processed for characterization using morphological and biochemical markers. During the course of differentiation cellular levels of reactive oxygen species (ROS), 8-hydroxy-2'-deoxyguanosine (8-OH-dG) and expression of ataxia-telangiectasia mutated (ATM) protein were estimated at time intervals (10, 20 and 30 days)...
March 3, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28259519/antigenic-fingerprinting-of-diphtheria-toxoid-adsorbed-to-aluminium-phosphate
#16
Janny Westdijk, Bernard Metz, Nanda Spruit, Wichard Tilstra, Johan van der Gun, Coenraad Hendriksen, Gideon Kersten
The antigenicity of alum-adsorbed diphtheria toxoid (DTd) was determined in combination vaccines, containing DTd, tetanus toxoid and inactivated poliovirus. A panel of monoclonal antibodies was used, covering five epitopes, distributed over the antigen. The resulting antigenic fingerprint of DTd demonstrates consistency of adsorption at antigen level in final product combination vaccines. The antigenic quality of DTd alone, adsorbed to aluminium phosphate, was also determined and compared with pre-adsorbed toxoid (starting material as well as toxoid desorbed from aluminium phosphate)...
March 1, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28237422/determination-of-pegfilgrastim-aggregates-by-size-exclusion-high-performance-liquid-chromatography-on-a-methacrylate-based-column
#17
Majid Shahbazi, Elnaz Tamaskany Zahedy, Shiva Kiumarsi, Mojtaba Hadi Soltanabad, Saleh Shahbazi Azar, Hossein Amini
A size-exclusion high-performance liquid chromatographic method using a methacrylate-based column was developed, validated and implemented for the determination of pegfilgrastim aggregates. The samples were directly injected into a TSKgel G4000PWXL column (7.5 mm × 300 mm, 10 μm, <500 A°) with a mobile phase of 100 mM phosphate, pH 2.5. Detection was made at 215 nm and analyses were run at a flow-rate of 0.6 ml/min at 10 °C. Vortex-mixing of samples produced oligomers, however, very high molecular weight aggregates were formed at high temperatures...
March 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28236560/the-dynamics-of-contract-plasma-fractionation
#18
REVIEW
Albert Farrugia, Daniela Scaramuccia
Plasma Derived Medicinal Products (PMDPs) are an essential component of the modern therapeutic armamentarium. They are differentiated from most other medicines in several ways, particularly the unique nature of the raw material used for their manufacture. Human plasma has been fractionated to PDMPs for the past 75 years, and the economics of manufacturing requires currently that as many products are harvested from each litre as is feasible and reflective of clinical needs. PDMPs may be purchased on the open market from the various commercial and not-for-profit (NFP) manufacturers...
March 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28233669/an-inhibition-enzyme-immuno-assay-exploring-recombinant-invariant-surface-glycoprotein-and-monoclonal-antibodies-for-surveillance-of-surra-in-animals
#19
G R Rudramurthy, P P Sengupta, M Ligi, H Rahman
The present study is aimed at the development of inhibition ELISA (I-ELISA) exploring monoclonal antibodies (MAbs) and recombinant invariant surface glycoprotein. The extracellular domain (ED) of invariant surface glycoprotein (ISG-75) from Trypanosoma evasni has been heterologously expressed in Pichia pastoris (X-33). The recombinant ISG-75 (rISG-75ED) was characterized by immunoblot and ELISA, followed by the production of MAbs against rISG-75ED. The MAbs were characterized by immunoblot and then explored in the development of I-ELISA for the detection of surra...
March 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28222938/the-role-of-mir-17-92-cluster-in-the-expression-of-tumor-suppressor-genes-in-unrestricted-somatic-stem-cells
#20
Rezvan Tavakoli, Saeid Vakilian, Lida Langroudi, Ehsan Arefian, Mehdi Sahmani, Masoud Soleimani, Fatemeh Jamshidi-Adegani
The miR-17-92 cluster consisted of seven miRNAs (mir-17-5p, -17-3p, -18a, -19a, -20a, -19b-1, and -92a-1). Previous studies have shown this cluster has been over-expressed in several cancers. The aim of this study was to evaluate the over-expression impacts of miR-17-92 on stem cells. In the current work, the effect of miR-17-92 cluster which was cloned in Lentiviral vector has been investigated on unrestricted somatic stem cells (USSCs). Tumor suppressor genes (p53, p15, RBL1, SMAD2, SMAD4, and MAPK-1) expression, especially p53, was considerably reduced...
March 2017: Biologicals: Journal of the International Association of Biological Standardization
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