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Biologicals: Journal of the International Association of Biological Standardization

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https://www.readbyqxmd.com/read/28716625/a-comparative-study-of-phenotypic-and-genotypic-first-and-second-line-drug-resistance-testing-of-mycobacterium-tuberculosis
#1
Fatemeh Sakhaee, Morteza Ghazanfari, Nayereh Ebrahimzadeh, Farzam Vaziri, Fatemeh Rahimi Jamnani, Mehdi Davari, Safoora Gharibzadeh, Fatemeh Hemati Mandjin, Abolfazl Fateh, Seyed Davar Siadat
This study aimed to evaluate the frequency of resistance to first- and second-line drugs using phenotypic and genotypic methods and its correlation with resistance-linked mutations in Mycobacterium tuberculosis (M. tb) isolated in Iran. Three different methods, including the indirect proportion method(PM), direct and indirect nitrate reductase assay(NRA), and direct sequencing were used to assess drug resistance. In this study, sensitivity, specificity, agreement, costs, and turnaround time of these methods were compared in 395 smear positive isolates...
July 15, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28693954/nano-encapsulation-of-chicken-immunoglobulin-igy-in-sodium-alginate-nanoparticles-in%C3%A2-vitro-characterization
#2
Mostafa Bakhshi, Firouz Ebrahimi, Shahram Nazarian, Jamil Zargan, Faeze Behzadi, Dawood Sadeghi Gariz
Controlled delivery of therapeutic agents by alginate nanoparticles became an attractive issue in the gastric organ. Some therapeutic agents such as proteins could not tolerate in severe condition in the gastrointestinal tract. In the present study, four concentrations of a specific IgY as a prophylactic agent against E. coli O157: H7 was entrapped in 0.2% w/v sodium alginate nanoparticles by ionic gelation method. Depending on the IgY concentration entrapment efficacy was 28.31-99.84%. The physicochemical and structural characteristics of free and IgY-loaded Alg NPs revealed that the individual particles exhibited a spherical shape with a diameter of 45-85 nm, and a negatively charged surface with a zeta potential value of 26-36 mV...
July 7, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28689674/determination-of-immune-status-in-dogs-against-cpv-2-by-recombinant-protein-based-latex-agglutination-test
#3
Jobin Thomas, Mithilesh Singh, T K Goswami, Philma Glora, Soumendu Chakravarti, Vishal Chander, Vikramaditya Upmanyu, Suman Verma, Chhavi Sharma, K Mahendran
Canine parvoviral enteritis is a highly contagious viral illness caused by canine parvovirus-2 (CPV-2) which affects puppies of mainly 6-20 weeks of age. Vaccination is pivotal in preventing and controlling CPV-2 infection. Determination of antibody status is a critical determinant for successful vaccination. The hemagglutination inhibition (HI) test is 'gold standard' test for quantification of antibodies specific to CPV-2, although the execution of this test is not feasible under field conditions. The present study was undertaken to develop a point of care testing to determine immune status prior to CPV-2 vaccination or to detect seroconversion in immunized dogs by latex agglutination test (LAT) using recombinant antigen...
July 6, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28688778/production-of-a-broad-specificity-monoclonal-antibody-and-application-as-a-receptor-to-detection-amatoxins-in-mushroom
#4
Kuo He, Qingwen Mao, Xiuyuan Zang, Yanyu Zhang, Hui Li, Donghao Zhang
In this study, we report the production of a monoclonal broad-specificity monoclonal antibody (mAb) specific for amatoxins and development of an indirect competitive immunoassay for detection of amatoxins in mushroom samples. In the assay, the complete antigen (α-amanitin-OVA) was used as coating antigen, and amatoxins as competitor competes with coating antigen to bind with mAb. Using this approach, The half-maximum inhibition concentrations (IC50) of α-amanitin, β-amanitin and γ-amanitin, and limits of detection (LODs, IC15) were 66...
July 5, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28666719/stem-cells-from-human-exfoliated-deciduous-teeth-reduce-tissue-infiltrating-inflammatory-cells-improving-clinical-signs-in-experimental-autoimmune-encephalomyelitis
#5
Cristiano Rossato, Wesley N Brandão, Sandra B R Castro, Danilo C de Almeida, Carlos M C Maranduba, Niels O S Camara, Jean P S Peron, Fernando S Silva
Stem cells from human exfoliated deciduous teeth (SHED) have great therapeutic potential and here, by the first time, we evaluated their immunomodulatory effect on experimental model of autoimmune encephalomyelitis (EAE). Specifically, we investigated the effect of SHED administration on clinical signs and cellular patterns in EAE model using Foxp3 GFP + transgenic mice (C57Bl/6-Foxp3GFP). The results showed that SHED infusion ameliorated EAE clinical score with reduced number of infiltrating IFN-γ(+)CD8(+), IL-4(+)CD8(+), IFN-γ(+)CD4(+) and IL-4(+)CD4(+) T cells into the central nervous system (CNS)...
June 27, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28666718/performance-of-microbiological-serological-molecular-and-modified-seminal-plasma-methods-in-the-diagnosis-of-brucella-abortus-in-semen-and-serum-of-bovine-bulls
#6
G Nardi Júnior, J Megid, L A Mathias, L Paulin, A F Vicente, A Cortez, F J P Listoni, G H B Lara, R G Motta, M G M Chacur, F M Monteiro, M G Ribeiro
Brucellosis remains as a major infectious disease of domestic animals and is considered a re-emerging zoonosis in several countries. B. abortus infections in bulls are related to reproductive tract infections, although infected animals show transient serological titers or nonreactor status. Thus, diagnosis of bovine brucellosis based exclusively on serological tests probably underestimates B. abortus infections in bulls. In this scenario, three hundred thirty-five serum samples from reproductively mature bovine bulls were subjected simultaneously to standard serodiagnosis using the rose Bengal test (RBT), 2-mercaptoethanol (2-ME), complement fixation (CFT), and fluorescence polarization assay (FPA)...
June 27, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28666717/drivers-and-barriers-in-the-consistency-approach-for-vaccine-batch-release-testing-report-of-an-international-workshop
#7
Martijn W P Bruysters, Marie-Jeanne Schiffelers, Marieke Hoonakker, Carmen Jungbaeck, Ian Ragan, Eddy Rommel, Ton van der Stappen, Laura Viviani, Ellen V Hessel, Arnoud M Akkermans, Rob J Vandebriel
Safety and potency assessment for batch release testing of established vaccines still relies partly on animal tests. An important avenue to move to batch release without animal testing is the consistency approach. This approach is based on thorough characterization of the vaccine, and the principle that the quality of subsequent batches is the consequence of the application of consistent production of batches monitored by a GMP quality system. Efforts to implement the consistency approach are supported by several drivers from industry, government, and research, but there are also several barriers that must be overcome...
June 27, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28645721/comparison-of-different-inactivation-methods-on-the-stability-of-indian-vaccine-strains-of-foot-and-mouth-disease-virus
#8
Arunava Sarkar, Ramasamy Periyasamy Tamil Selvan, Subodh Kishore, Kondabattula Ganesh, Veerakyathappa Bhanuprakash
In this study, the efficiency of binary ethyleneimine (BEI) in combination with formaldehyde (FA) and glutaraldehyde (GTA) in inactivating the Indian FMDV vaccine strains is compared. The acceptable safety of virus inactivation was faster and the inactivation rates were increased many-folds with combination of inactivants than BEI alone. FMDV A was inactivated rapidly than the other two serotypes with BEI + FA combination. Inactivation plots were linear for all the serotypes irrespective of inactivation process...
June 20, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28633975/efficacy-of-inactivation-of-viral-contaminants-in-hyperimmune-horse-plasma-against-botulinum-toxin-by-low-ph-alone-and-combined-with-pepsin-digestion
#9
Amram Torgeman, Nurit Mador, Marina Dorozko, Aliza Lifshitz, Naomi Eschar, Moshe D White, Dana G Wolf, Eyal Epstein
Assuring viral safety of horse plasma-derived products is fundamental for ethical and regulatory reasons. We previously demonstrated the ability of pepsin digestion at low pH to inactivate West Nile and Sindbis viruses in horse plasma. The present study further examined the efficiency of pepsin digestion to inactivate four additional viruses: HSV-1 and BVDV (lipid-enveloped), BPV and Reo-3 (nonenveloped). These viruses were spiked into hyperimmunized horse plasma against botulinum toxin and subjected to low pH (3...
June 17, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28619479/a-demonstration-of-analytical-similarity-comparing-a-proposed-biosimilar-pegfilgrastim-and-reference-pegfilgrastim
#10
Stephen Brokx, Louise Scrocchi, Nirmesh Shah, Jason Dowd
BACKGROUND: Recombinant human granulocyte-colony stimulating factor (G-CSF, filgrastim) is used primarily to reduce incidence and duration of severe neutropenia and its associated complications in cancer patients that have received a chemotherapy regimen. The pegylated form of filgrastim, "pegfilgrastim", is a long-acting form that requires only a once-per-cycle administration for the management of chemotherapy-induced neutropenia. Apobiologix, a division of ApoPharma USA, Inc., and Intas Pharmaceuticals Limited have co-developed a proposed pegfilgrastim biosimilar to US-licensed pegfilgrastim...
June 12, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28602577/fabrication-of-porous-scaffolds-with-decellularized-cartilage-matrix-for-tissue-engineering-application
#11
Bita Nasiri, Shohreh Mashayekhan
Due to the avascular nature of articular cartilage, damaged tissue has little capacity for spontaneous healing. Three-dimensional scaffolds have potential for use in tissue engineering approach for cartilage repair. In this study, bovine cartilage tissue was decellularized and chemically crosslinked hybrid chitosan/extracellular matrix (ECM) scaffolds were fabricated with different ECM weight ratios by simple freeze drying method. Various properties of chitosan/ECM scaffolds such as microstructure, mechanical strength, swelling ratio, and biodegradability rate were investigated to confirm improved structural and biological characteristics of chitosan scaffolds in the presence of ECM...
June 8, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28596049/modern-science-for-better-quality-control-of-medicinal-products-towards-global-harmonization-of-3rs-in-biologicals-the-report-of-an-epaa-workshop
#12
Katrin Schutte, Anna Szczepanska, Marlies Halder, Klaus Cussler, Ursula G Sauer, Catrina Stirling, Sylvie Uhlrich, Iwona Wilk-Zasadna, David John, Martin Bopst, Joerg Garbe, Harrie L Glansbeek, Robin Levis, Pieter-Jan Serreyn, Dean Smith, Paul Stickings
This article summarizes the outcome of an international workshop organized by the European Partnership for Alternative Approaches to Animal Testing (EPAA) on Modern science for better quality control of medicinal products: Towards global harmonization of 3Rs in biologicals. As regards the safety testing of biologicals, the workshop participants agreed to actively encourage the deletion of abnormal toxicity tests and target animal batch safety tests from all relevant legal requirements and guidance documents (country-specific guidelines, pharmacopoeia monographs, WHO recommendations)...
June 5, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28596048/impact-of-antigens-adjuvants-and-strains-on-sexually-dimorphic-antibody-response-to-vaccines-in-mice
#13
Xin Li, Sheng Guo, Lei Yang, Li Hua, Zhiqin Li, Xu Hao, Yongli Yu, Wei Sun, Liying Wang
Sexually dimorphic antibody response to vaccines has long been noticed. In addition to sex hormones, other factors such as antigens, adjuvants and strains of mice, as shown by indirect evidence, could also impact the sexual dimorphism. To clarify this, we immunized both gender mice of distinct strains with inactivated FMDV or HBsAg with or without adjuvants, and detected the specific antibody response of the mice. We found that in absence of adjuvants, the recombinant HBsAg but not the inactivated FMDV induced enhanced IgG antibody response in the female BALB/c mice...
June 5, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28579353/in%C3%A2-vitro-differentiation-of-menstrual-blood-stem-cells-into-keratinocytes-a-potential-approach-for-management-of-wound-healing
#14
Maryam Akhavan-Tavakoli, Maryam Fard, Sayeh Khanjani, Sona Zare, Haleh Edalatkhah, Davood Mehrabani, Amir-Hassan Zarnani, Reza Shirazi, Somaieh Kazemnejad
The skin wounds caused by insults should be treated immediately to restore the functions and integrity. Recent studies suggest that stem cells-based therapies may be applicable in wound healing. Newly defined menstrual blood-derived stem cells (MenSCs) show high rate of cell proliferation and trans-differentiation potency to various cell types. However, MenSCs potential to generate keratinocyte for future therapeutic use of skin lesions has been remained to investigate. We cultivated MenSCs in the presence of isolated foreskin derived-keratinocytes using an indirect co-culture system and evaluated efficiency of this protocol to generate keratinocytes using immunofluorescent staining and Real Time PCR technique...
June 1, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28554726/microbial-expression-of-exendin-4-analog-and-its-efficacy-in-mice-model
#15
Bhargav Prasad Kodaganti, Pavithra Mukunda, Pravinkumar Dakshinamurthy, Yogendra Manjunath, Bharath Ravindra Shenoy, Veeresha Kamanagowda, Bairavabalakumar Natarajan, Amol Maliwalave, Divya Unnikrishnan, Sathyabalan Murugesan, Vivek Halan, Maloy Ghosh, Sunit Maity
Exendin-4 is a GLP 1 agonist incretin-mimetic peptide hormone comprising 39 amino acids. Exenatide (Byetta(®)) is a chemically synthesized version of Exendin-4 with an additional C-terminal amidation. Exenatide acts as a GLP-1 receptor agonist. This paper illustrates the method adopted for cloning, fermentation and purification of recombinant Exendin-4 analog expressed in Escherichia coli. The biologically expressed analog was extensively characterized using different orthogonal methods to confirm their biological activity and physicochemical properties...
May 26, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28551064/stability-of-oxytocin-along-the-supply-chain-a-who-observational-study
#16
Umit Kartoglu, Mariana Widmer, Metin Gulmezoglu
Postpartum haemorrhage is the leading cause of maternal mortality in low-income countries and oxytocin is the drug recommended by WHO for preventing and treating it. There are concerns about the quality of oxytocin available at the service level provider. The study aimed to document how temperature variations along the supply chain affect quality of oxytocin. The study was run from March to June 2015 in four regions of Ghana. 130 ampoules of oxytocin were shipped from the manufacturer to service level following Ghanaian public sector supply chain...
May 25, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28549939/scientific-consultation-on-the-safety-and-containment-of-new-poliovirus-strains-for-vaccine-production-clinical-regulatory-testing-and-research-report-of-a-meeting-held-at-nibsc-potters-bar-hertfordshire-uk-6-7th-july-2016
#17
Philip D Minor, Blanche Lane, South Mimms, Potters Bar
When poliomyelitis is totally eradicated from the natural world containment will be vital to prevent its re-emergence. The matter has become pressing as type 2 component of oral polio vaccine was completely withdrawn by May 2016 as wild ty[e 2 was declared eradicated. Work on polioviruses must be contained in accordance with GAPIII (the third version of the Global Action Plan of WHO). Some activities will be essential for years after eradication. Vaccine production and control, surveillance and supportive applied and academic research must all continue...
May 23, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28549938/results-of-a-harmonized-endotoxin-recovery-study-protocol-evaluation-by-14-biophorum-operations-group-bpog-member-companies
#18
Jay Bolden, Michael Knight, Shahrzad Stockman, Bastian Omokoko
Significant regulatory and biopharmaceutical manufacturing attention has been recently generated regarding the inability to recover purified lipopolysaccharide in certain biopharmaceutical products, specifically those containing a chelator and surfactant. Disparate data has been generated and submitted during regulatory review. Study design is thought to significantly impact, and cause the confounding data. The BioPhorum Operations Group (BPOG) is an industry consortium of biopharmaceutical manufacturers. A BPOG team developed a collaborative experiment to determine if multiple laboratories could execute a harmonized protocol and reach equivalent conclusions...
May 23, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28522247/potential-of-multi-component-antigens-for-tuberculosis-diagnosis
#19
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
#20
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 9, 2017: Biologicals: Journal of the International Association of Biological Standardization
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