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Biologicals: Journal of the International Association of Biological Standardization

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https://www.readbyqxmd.com/read/30017557/development-of-screening-method-for-intranasal-influenza-vaccine-and-adjuvant-safety-in-preclinical-study
#1
Yuki Hiradate, Eita Sasaki, Haruka Momose, Hideki Asanuma, Keiko Furuhata, Mamiko Takai, Taiki Aoshi, Hiroshi Yamada, Ken J Ishii, Kentaro Tanemura, Takuo Mizukami, Isao Hamaguchi
Recently, many vaccine adjuvants have been developed; however, most of the newly developed adjuvants have been dropped out of preclinical and clinical trials owing to their unexpected toxicity. Thus, the development of highly quantitative and comparable screening methods for evaluating adjuvant safety is needed. In a previous study, we identified specific biomarkers for evaluating the safety of an intranasal influenza vaccine with CpG K3 adjuvant by comparing biomarker expression. We hypothesized that these biomarkers might be useful for screening newly developed adjuvant safety...
July 13, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/30017556/successful-slow-tocilizumab-desensitization-in-a-patient-with-adult-onset-still-disease
#2
LETTER
Tuba Erdogan, Nazife Sule Yasar Bilge, Timucin Kasifoglu
No abstract text is available yet for this article.
July 13, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29970288/development-of-a-relative-potency-test-using-elisa-for-human-rabies-vaccines
#3
Zejun Wang, Yan Sun, Xianfu Wu, Darin S Carroll, Wenli Lv, Lei You, Yaqi Ji, Jinrong Shi, Jiaxin Yan, Gelin Xu, Shengli Meng
The NIH potency test for human rabies vaccines has disadvantages for use, especially in developing countries where rabies is endemic and prophylaxis needs ample, rapid, and reliable vaccine supplies. In China, 60-75 million doses of human rabies vaccines are administered each year. Vaccine quality control is of paramount importance, as is the release of potency-validated vaccines. We intended to design an alternative to the NIH in vivo method, and developed a relative potency test using an ELISA. Using Pearson's correlation analysis, we found a close relationship between the rabies vaccine glycoprotein content in vitro and the potency values in vivo...
June 30, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29941335/establishment-of-the-first-international-standard-for-human-anti-typhoid-capsular-vi-polysaccharide-igg
#4
Sjoerd Rijpkema, Jason Hockley, Alastair Logan, Peter Rigsby, Eleanor Atkinson, Celina Jin, Haoyu Liang, Novilia S Bachtiar, Jae Seung Yang, Akshay Goel, Venkatesan Ramasamy, Marcela F Pasetti
Vi capsular polysaccharide (Vi) conjugate vaccines prevent Typhoid in infants and young children. Several Vi-conjugate vaccines are being developed and an International Standard (IS) for human anti-Vi IgG is required to compare their immunogenicity. The suitability of 16/138 as an IS for human anti-Vi IgG was assessed alongside U.S. reference reagent Vi-IgGR1, 2011 , previous candidate IS 10/126 and individual sera. 16/138 is a pool of post-vaccination sera from volunteers receiving either Vi Tetanus Toxoid conjugate vaccine or plain Vi vaccine...
June 22, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29941334/detection-of-bovine-viral-diarrhoea-virus-nucleic-acid-but-not-infectious-virus-in-bovine-serum-used-for-human-vaccine-manufacture
#5
Majid Laassri, Edward T Mee, Sarah M Connaughton, Hasmik Manukyan, Marion Gruber, Carmen Rodriguez-Hernandez, Philip D Minor, Silke Schepelmann, Konstantin Chumakov, David J Wood
Bovine viral diarrhoea virus (BVDV) is a cattle pathogen that has previously been reported to be present in bovine raw materials used in the manufacture of biological products for human use. Seven lots of trivalent measles, mumps and rubella (MMR) vaccine and 1 lot of measles vaccine from the same manufacturer, together with 17 lots of foetal bovine serum (FBS) from different vendors, 4 lots of horse serum, 2 lots of bovine trypsin and 5 lots of porcine trypsin were analysed for BVDV using recently developed techniques, including PCR assays for BVDV detection, a qRT-PCR and immunofluorescence-based virus replication assays, and deep sequencing to identify and genotype BVDV genomes...
June 22, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29935930/first-evaluation-of-endotoxins-in-veterinary-autogenous-vaccines-produced-in-italy-by-lal-assay
#6
Di Paolo Antonella, Forti Katia, Anzalone Lucia, Corneli Sara, Pellegrini Martina, Severi Giulio, Cagiola Monica
Endotoxin contamination is a serious concern for manufacturers of biological products and vaccines in terms of not only quality but also safety parameters. We evaluated the endotoxin presence in different veterinary autogenous vaccines produced by the Pharmaceutical Unit at the Experimental Zooprophylactic Institute of Umbria and Marche "Togo Rosati" (IZSUM). According to the 3Rs principles (Replace, Reduce, Refine), which aim to progressively reduce animal use in the quality control process, we tested the vaccines obtained from gram-negative bacteria and adjuvants by the limulus amebocyte lysate (LAL) assay...
June 21, 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
#7
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
#8
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
#9
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
#10
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/29884574/comparative-effectiveness-of-three-dimensional-scaffold-differentiation-media-and-co-culture-with-native-cardiomyocytes-to-trigger-in-vitro-cardiogenic-differentiation-of-menstrual-blood-and-bone-marrow-stem-cells
#11
Maryam Rahimi, Amir-Hassan Zarnani, Sahba Mobini, Somaieh Khorasani, Maryam Darzi, Somaieh Kazemnejad
The main purpose of this study was to find effectiveness of 3D silk fibroin scaffold in comparison with co-culturing in presence of native cardiomyocytes on cardiac differentiation propensity of menstural blood(MenSCs)-versus bone marrow-derived stem-cells (BMSCs). We showed that both 3D fibroin scaffold and co-culture system supported efficient cardiomyogenic differentiation of MenSCs and BMSCs, as judged by the expression of cardiac-specific genes and proteins, Connexin-43, Connexin-40, alpha Actinin (ACTN-2), Tropomyosin1 (TPM1) and Cardiac Troponin T (TNNT2)...
July 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29871790/electrospun-composite-plla-oyster-shell-scaffold-enhances-proliferation-and-osteogenic-differentiation-of-stem-cells
#12
Roghaieh Didekhani, Mahmoud Reza Sohrabi, Ehsan Seyedjafari, Masoud Soleimani, Hana Hanaee-Ahvaz
In bone tissue engineering, bioceramics are of the most widely used materials for treatment of bone defects clinically. The composites of bioceramic/polymer fibrous scaffolds have been designed and developed to fulfill the mechanical and biological requirements of the damaged tissue. In the present study, oyster shell (OS) as a bioceramic in combination with the biodegradable and biocompatible poly (l-lactide) has been used to prepare a new tissue-engineered composite. The morphology, porosity, water contact angle and mechanical properties of scaffolds were investigated...
July 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29861269/host-cell-protein-testing-strategy-for-hepatitis-b-antigen-in-hexavalent-vaccine-towards-a-general-testing-strategy-for-recombinant-vaccines
#13
Audrey Toinon, Christelle Fontaine, Laurent Thion, Beata Gajewska, Bruce Carpick, Nolwenn Nougarede, Sylvie Uhlrich
BACKGROUND: Recombinant proteins expressed in host cell systems may contain host cell proteins (HCP) as impurities. While there is no clear evidence of clinical adverse events attributable to HCP, HCP levels and profiles must be documented to meet regulatory requirements and to understand the consistency of the biological product and manufacturing process. We present a general strategy for HCP characterization applied to a recombinant protein antigen, Hepatitis B surface antigen (HBsAg) used in a multivalent vaccine...
July 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29779958/development-of-an-anti-epo-antibody-detection-kit-based-on-lab-on-a-chip-and-bridging-antibody-technologies
#14
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...
July 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
#15
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...
July 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
#16
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...
July 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
#17
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...
May 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
#18
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)...
May 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
#19
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...
May 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
#20
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...
May 2018: Biologicals: Journal of the International Association of Biological Standardization
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