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Biologicals: Journal of the International Association of Biological Standardization

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https://www.readbyqxmd.com/read/29779958/development-of-an-anti-epo-antibody-detection-kit-based-on-lab-on-a-chip-and-bridging-antibody-technologies
#1
Jin-Gyo Oh, Jihyun Seong, Sunmi Han, Tae-Hwe Heo
Immunogenicity is a major concern in the use of biological drugs. In particular, antibody-mediated pure red cell aplasia (PRCA) is a rare condition that is caused by administration of recombinant erythropoietin. There are numerous assay platforms for detect EPO anti-drug antibody (ADA), and most have appropriate assay sensitivity, but in need of improvement in terms of assay turnaround time and user accessibility. Here, the new method was developed based on lab-on-a-chip technology and bridging ELISA. The FREND™ Cartridge is equipped with a microfluidic lateral flow channel, enabling easy, fast and accurate immunoassays with small sample volumes...
May 17, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29776735/coculture-of-conjunctiva-derived-mesenchymal-stem-cells-cjmscs-and-corneal-epithelial-cells-to-reconstruct-the-corneal-epithelium
#2
Fatemeh Soleimanifar, Yousef Mortazavi, Samad Nadri, Maryam Islami, Saeid Vakilian
Coculture systems are widely used in tissue engineering to mimic cell-cell interactions between different populations. This study aimed to find an improved and convenient system for the corneal epithelial differentiation of conjunctiva derived mesenchymal stem cells (CJMSCs). Thus, the cells were used to reconstruct corneal epithelial cells. Obtained by flow cytometry data, 51.9% of isolated CJMSCs were immune reactive for SSEA4+ antibody which are more potent to differentiate into corneal epithelial cells...
May 15, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29759890/distribution-and-absence-of-generalized-lesions-in-mice-following-single-dose-intramuscular-inoculation-of-the-vaccine-candidate-mva-mers-s
#3
Martin C Langenmayer, Anna-Theresa Lülf-Averhoff, Silvia Adam-Neumair, Robert Fux, Gerd Sutter, Asisa Volz
Modified Vaccinia Virus Ankara (MVA) is a highly attenuated and replication-deficient virus serving as vaccine against infectious diseases. Here, we assessed the in vivo distribution of a recombinant MVA candidate vaccine against the Middle Eastern Respiratory Syndrome (MVA-MERS-S) in mice. Intramuscularly inoculated mice were necropsied at different time points and examined by histology, immunohistochemistry and real-time PCR. We detected inflammation and myonecrosis at the parenteral site and hyperplasia of the draining lymph nodes...
May 11, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29753590/adherence-to-biologic-therapy-does-it-vary-with-ethnicity
#4
Muhammad K Nisar, Waqas Mirza, Aneesa Rafiq, Michael Eisenhut
BackgroundPoor adherence to therapy remains a significant barrier to improving clinical outcomes in rheumatic diseases and carries a major financial burden. It has been linked to medication related patient beliefs, which were reported to differ between ethnic groups. Little is known about these variations in biologic therapies cohorts. The purpose of this study was to identify potential determinants of adherence to biologic drugs including an assessment of the influence of beliefs about medicines and compare determinants of adherence between patients of Caucasian versus other ethnicities (OE)...
May 9, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29753589/development-of-a-highly-sensitive-pcr-dna-chip-method-to-detect-mycoplasmas-in-a-veterinary-modified-live-vaccine
#5
Sylvie Mbelo, Virginie Gay, Stephanie Blanchard, Eric Abachin, Stephanie Falque, Jacques Lechenet, Hervé Poulet, Blandine de Saint-Vis
Mycoplasmas are potential contaminants that introduce undesirable changes in mammalian cell cultures. They frequently contaminate cell substrates and other starting materials used for manufacturing cell-derived biologics, such as vaccines and pharmaceutical products. Mycoplasma purity testing of live vaccines, active ingredients, raw material, and seed lots is required during vaccine production. Previously, testing using a time-consuming, costly 28-day culture assay, which lacks sensitivity for species that do not grow in culture, was required in the European Pharmacopoeia (Ph...
May 9, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29752158/immortalization-of-chicken-embryonic-liver-derived-cell-line-by-stable-expression-of-hmrp18s-2-for-serotype-4-fowl-adenovirus-propagation
#6
Lei Feng, Li Chen, Junwen Yun, Zhixiang Bi, Yinghua Tang, Peipei Wu, Jibo Hou
Inclusion body hepatitis and hydropericardium-hepatitis syndrome caused by serotype 4 fowl adenovirus (FAdV-4) have emerged in China since 2013. FAdV is usually propagated in primary chicken embryonic liver cells or embryo yolk sac. The aim of this work was to develop an immortalized CEL cell line by stable expression of human mitochondrial ribosomal protein 18S-2, named CEL-hMRP18S-2 cells, for the propagation of FAdV-4. The maximum cell density of CEL-hMRP18S-2 cells could reach 2.65 × 106  cells/ml in four-days culture...
May 8, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29706309/drug-survival-of-biologic-therapies-for-the-treatment-of-psoriasis-results-of-slovenian-national-registry
#7
Tomaz Lunder, Pij Marko, Natasa Koser Kolar, Boris Kralj, Nada Kecelj Leskovec
The study was designed as observational retrospective analysis of the data from Slovenian Registry of patients with moderate and severe psoriasis treated with adalimumab, etanercept, infliximab or ustekinumab from 2005 to 2015. The survival rates of biologics were compared using survival analysis, and predictors of discontinuation were evaluated using a Cox regression model. All biologics have been prescribed as a first line therapy for moderate or severe psoriasis; 650 (94.9%) adalimumab, 254 (72.0%) ustekinumab, 76 (69...
April 26, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29685804/investigation-of-the-kinetics-and-mechanism-of-low-endotoxin-recovery-in-a-matrix-for-biopharmaceutical-drug-products
#8
Johannes Reich, Hiroshi Tamura, Isao Nagaoka, Hubert Motschmann
The inability to detect endotoxin added to undiluted drug samples has been called: Low Endotoxin Recovery (LER). The phenomenon has caused concerns amongst drug manufacturing quality control scientists in that manufactured solutions contaminated with endotoxin could show false-negative results via routine Limulus-based tests. The time-dependent appearance of LER has been analyzed in detail to provide a better understanding of the mechanism. The assumption has been that the root-cause of LER involves the interplay of endotoxin with surfactants and results in aggregate structures that are complexed with surfactants...
April 20, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29625872/construction-of-scaffolds-composed-of-acellular-cardiac-extracellular-matrix-for-myocardial-tissue-engineering
#9
Kamyar Esmaeili Pourfarhangi, Shohreh Mashayekhan, Sasan Ghanbari Asl, Zahra Hajebrahimi
High rates of mortality and morbidity stemming from cardiovascular diseases unveil extreme limitations in current therapies despite enormous advances in medical and pharmaceutical sciences. Following myocardial infarction (MI), parts of myocardium undergo irreversible remodeling and is substituted by a scar tissue which eventually leads to heart failure (HF). To address this issue, cardiac patches have been utilized to initiate myocardial regeneration. In this study, a porous cardiac patch is fabricated using a mixture of decellularized myocardium extracellular matrix (ECM) and chitosan (CS)...
April 3, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29610042/regulatory-pathways-to-enable-the-licencing-of-alternatives-to-antibiotics
#10
Faye Ioannou, Cindy Burnsteel, David K J Mackay, Cyril G Gay
Effective alternatives to antibiotics (ATA) such as vaccines, antibodies, phage therapies, prebiotics, probiotics and herbal medicines can be used in place of traditional antibiotics in a way that does not compromise animal health as means of tackling the growing threat to both animal and human health from antimicrobial resistance (AMR). This paper reflects the key points on the approaches that were discussed during the 2nd International Symposium on ATA between regulatory agencies, veterinary product companies representing largely the pharmaceutical and feed-additive sectors, academia and other stakeholders on regulatory pathways to enable the licensing of alternatives to antibiotics for food producing animals...
March 30, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29580693/innovative-in-cellulo-method-as-an-alternative-to-in-vivo-neurovirulence-test-for-the-characterization-and-quality-control-of-human-live-yellow-fever-virus-vaccines-a-pilot-study
#11
Anaelle da Costa, Christophe Prehaud, Cecile Khou, Nathalie Pardigon, Aure Saulnier, Nolwenn Nougarede, Monique Lafon
Live attenuated vaccines have proved to be mostly valuable in the prevention of infectious diseases in humans, especially in developing countries. The safety and potency of vaccine, and the consistency of vaccine batch-to-batch manufacturing, must be proven before being administrated to humans. For now, the tests used to control vaccine safety largely involve animal testing. For live viral vaccines, regulations require suppliers to demonstrate the absence of neurovirulence in animals, principally in non-human primates and mice...
March 23, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29573967/human-challenge-trials-in-vaccine-development-rockville-md-usa-september-28-30-2017
#12
Marc F D Baay, Thomas L Richie, Pieter Neels
The International Alliance for Biological Standardization organized the second workshop on human challenge trials (HCT) in Rockville, MD, in September 2017. The objective of this meeting was to examine the use of HCT, in response to the continuing human suffering caused by infectious diseases, preventable by the development of new and improved vaccines. For this, the approach of HCT could be valuable, as HCT can provide key safety, tolerability, immunogenicity, and efficacy data, and can be used to study host-pathogen biology...
March 21, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29572108/establishment-of-the-1st-who-international-standard-for-anti-ev71-serum-human
#13
Gillian Cooper, Qunying Mao, Laura Crawt, Yiping Wang, Thomas Dougall, Peter Rigsby, Zhenglun Liang, Miao Xu, Philip Minor, Junzhi Wang, Javier Martin
Enterovirus A71 (EV71) is the major causative agent of severe and fatal hand, foot and mouth disease. There is plenty of evidence that EV71 has circulated widely in the Western Pacific Region for the last twenty years. Vaccines against EV71 are already available or under development. A collaborative study to establish the 1st WHO International Standard for anti-EV71 serum (Human) was conducted to ensure that methods used to measure the serum neutralizing activity or antibody levels against EV71 are accurate, sensitive and reproducible...
March 20, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29548791/assessing-the-potency-and-immunogenicity-of-inactivated-poliovirus-vaccine-after-exposure-to-freezing-temperatures
#14
Jessica A White, Marcus Estrada, William C Weldon, Konstantin Chumakov, Diana Kouiavskaia, Jacqueline Fournier-Caruana, Eric Stevens, Howard E Gary, Edmond F Maes, M Steven Oberste, Cynthia J Snider, Abhijeet Anand, Dexiang Chen
According to manufacturers, inactivated poliovirus vaccines (IPVs) are freeze sensitive and require storage between 2°C and 8°C, whereas oral poliovirus vaccine requires storage at -20 °C. Introducing IPV into ongoing immunization services might result in accidental exposure to freezing temperatures and potential loss of vaccine potency. To better understand the effect of freezing IPVs, samples of single-dose vaccine vials from Statens Serum Institut (VeroPol) and multi-dose vaccine vials from Sanofi Pasteur (IPOL) were exposed to freezing temperatures mimicking what a vaccine vial might encounter in the field...
May 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29523387/research-on-the-advancement-of-standards-and-specifications-of-biologics-in-korea
#15
LETTER
Ji-Young Son, Chang-Ho Kim, Oh-Seok Kwon, Hea-Young Cho
No abstract text is available yet for this article.
May 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29519752/identification-of-t-cell-and-b-cell-epitopes-against-indian-hcv-genotype-3a-for-vaccine-development-an-in-silico-analysis
#16
Varun Chauhan, Mini P Singh, Radha K Ratho
Hepatitis C virus (HCV) infects almost 150 million people and is a leading cause of liver disease worldwide. It has been classified into seven genotypes; the most common genotype affecting Indian population is genotype 3 (60-70%). Currently there is no vaccine for any genotype of HCV. In order to develop peptide based vaccine against HCV, it is important to identify the conservancy in the circulating genotypes, along with the Human Leucocyte Antigen (HLA) alleles in the target population. The present study aims to identify conserved CD4 and CD8 T cells and B cell epitopes against Indian HCV-genotype-3a using an in silico analysis...
May 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29503205/poly-lactic-co-glycolic-acid-plga-tio-2-nanotube-bioactive-composite-as-a-novel-scaffold-for-bone-tissue-engineering-in-vitro-and-in-vivo-studies
#17
Hossein Eslami, Hamidreza Azimi Lisar, Tahereh Sadat Jafarzadeh Kashi, Mohammadreza Tahriri, Mojtaba Ansari, Tohid Rafiei, Farshid Bastami, Alireza Shahin-Shamsabadi, Fatemeh Mashhadi Abbas, Lobat Tayebi
The aim of this study was to synthesize and characterize novel three-dimensional porous scaffolds made of poly (lactic-co-glycolic acid)/TiO2 nanotube (TNT) composite microspheres for bone tissue engineering applications. The incorporation of TNT greatly increases mechanical properties of PLGA/TNT microsphere-sintered scaffold. The experimental results exhibit that the PLGA/0.5 wt% TNT scaffold sintered at 100 °C for 3 h showed the best mechanical properties and a proper pore structure for tissue engineering...
May 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29475730/evaluation-of-the-use-of-various-rat-strains-for-immunogenic-potency-tests-of-sabin-derived-inactivated-polio-vaccines
#18
Yuichi Someya, Yasushi Ami, Reiko Takai-Todaka, Akira Fujimoto, Kei Haga, Kosuke Murakami, Yoshiki Fujii, Haruko Shirato, Tomoichiro Oka, Takashi Shimoike, Kazuhiko Katayama, Takaji Wakita
Slc:Wistar rats have been the only strain used in Japan for purpose of evaluating a national reference vaccine for the Sabin-derived inactivated polio vaccine (sIPV) and the immunogenicity of sIPV-containing products. However, following the discovery that the Slc:Wistar strain was genetically related to the Fischer 344 strain, other "real" Wistar strains, such as Crlj:WI, that are available worldwide were tested in terms of their usefulness in evaluating the immunogenicity of the past and current lots of a national reference vaccine...
March 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29456027/enhanced-chondrogenesis-differentiation-of-human-induced-pluripotent-stem-cells-by-microrna-140-and-transforming-growth-factor-beta-3-tgf%C3%AE-3
#19
Hossein Mahboudi, Masoud Soleimani, Seyed Ehsan Enderami, Mousa Kehtari, Abdolreza Ardeshirylajimi, Mohamad Eftekhary, Bahram Kazemi
Induced pluripotent stem cells (iPSCs) make an attractive source for regenerative medicine. The objective of our study was to establish a new method for differentiation of human iPSCs toward chondrocyte by overexpression of MicroRNA-140 (miR-140) and use of transforming growth factor beta 3 (TGFβ3) in high-cell density culture systems. We prepared vectors and then was used for recombinant Lenti virus production in HEK-293 cell. Transducted cells were selected and cultured in pellet culture system and were harvested after days 7, 14 and 21...
March 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29434001/validation-and-implementation-of-planova%C3%A2-bioex-virus-filters-in-the-manufacture-of-a-new-liquid-intravenous-immunoglobulin-in-china
#20
Shan Ma, Guang Li Pang, Yu Juan Shao, Tomoko Hongo-Hirasaki, Meng Xian Shang, Marcus Inouye, Chang Yong Jian, Meng Zhao Zhu, Hu Hu Yang, Jian Feng Gao, Zhi Ying Xi, Dian Wei Song
There is a continuous need to improve the viral safety of plasma products, and we here report the development and optimization of a manufacturing-scale virus removal nanofiltration step for intravenous immunoglobulin (IVIG) using the recently introduced Planova™ BioEX filter. IVIG throughput was examined for various operating parameters: transmembrane pressure, temperature, protein concentration, and prefiltration methods. The developed procedure was based on filtering undiluted process solution (50.0 g/l IVIG) under constant transmembrane pressure filtration at 294 kPa and 25 °C following prefiltration with a 0...
March 2018: Biologicals: Journal of the International Association of Biological Standardization
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