journal
MENU ▼
Read by QxMD icon Read
search

Biologicals: Journal of the International Association of Biological Standardization

journal
https://www.readbyqxmd.com/read/28645721/comparison-of-different-inactivation-methods-on-the-stability-of-indian-vaccine-strains-of-foot-and-mouth-disease-virus
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
journal
journal
30393
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"