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Biologicals: Journal of the International Association of Biological Standardization

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https://www.readbyqxmd.com/read/30201529/establishment-of-the-first-international-standard-for-human-anti-typhoid-capsular-vi-polysaccharide-igg
#1
Sjoerd Rijpkema, Jason Hockley, Alastair Logan, Peter Rigsby, Eleanor Atkinson, Celina Jin, David Goldblatt, Haoyu Liang, Novilia S Bachtiar, Jae Seung Yang, Akshay Goel, Venkatesan Ramasamy, Marcela F Pasetti, Andrew J Pollard
Vi capsular polysaccharide (Vi) conjugate vaccines, which can prevent typhoid in infants and young children, are being developed. Comparative immunogenicity studies are facilitated by an International Standard (IS) for human anti-Vi IgG. 16/138, a pool of sera from volunteers which received either Vi conjugate vaccine or plain Vi vaccine, was assessed as an IS alongside U.S. reference reagent Vi-IgGR1, 2011 . Samples were tested in a commercial ELISA (n = 7), a standardised ELISA based on biotinylated Vi (n = 7) and in-house ELISAs (n = 7)...
September 7, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/30181080/immunization-with-salmonella-abortusequi-phage-lysate-protects-guinea-pig-against-the-virulent-challenge-of-sae-742
#2
Abhishek, B Kumar, Anjay, A K Mishra, C Prakash, A Priyadarshini, M Rawat
Salmonella Abortusequi causes important clinical diseases in horses possibly leading to abortion. In the present investigation, the protective efficacy of both plain and aluminum hydroxide gel adjuvanted phage lysate was evaluated in guinea pig model. Broad host range bacteriophage PIZ -SAE-2, was characterized and used for generation of lysates. Three different lysate batches, produced through separate cycles and characterized, were pooled together for immunization study. Plain and adjuvanted phage lysate preparations elicited both humoral and cellmediated immunity...
September 1, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/30177432/influence-of-hydrodynamic-pressure-on-chondrogenic-differentiation-of-human-bone-marrow-mesenchymal-stem-cells-cultured-in-perfusion-system
#3
Soheila Zamanlui, Leila Mohammadi Amirabad, Masoud Soleimani, Shahab Faghihi
The natural conditions of chondrocytes in native cartilage including mechanical forces and surface topology could be simulated to enhance chondrogenesis. A perfusion system recapitulating the hydrodynamic pressure of cartilage tissue is designed. Mesenchymal stem cells (MSCs) are isolated and seeded on aligned nanofibrous PCL/PLGA scaffolds that mimic the structure of superficial zone of articular cartilage. The cell-seeded scaffolds are placed into the perfusion bioreactor and exposed to chondrogenic differentiating medium...
August 31, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/30173936/a-risk-assessment-on-extraneous-virus-contamination-in-a-viral-vaccine-production-environment-justifies-waiving-of-in-vivo-testing
#4
Uffe B Westergaard, Bodil van Overeem Hansen, Kasper Abildgaard Rud, Claus Nielsen, Gitte Stawski, Kaare R Hasløv
For many years in vivo assays have been a corner stone in safety testing of vaccines for human use. However, there is now an increasing regulatory focus on replacement, reduction and refinement of methods involving animal use. Accordingly, European Pharmacopoeia (Ph.Eur.) monographs and chapters are currently being revised to reduce or discontinue the use of animals in safety and other testing, when such in vivo tests are not absolutely necessary to facilitate risk mitigation. In the current study, a risk assessment of extraneous agents in viral vaccine production has been carried out and it is concluded that only the handling procedures carried out by the technical personnel pose a risk for extraneous viral contamination...
August 30, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/30153952/preparation-of-f-ab-2-antivenom-in-iraq-against-scorpion-hottentotta-saulcyi-venom
#5
Brwa Nawzad Ismael, Kasim Sakran Abass, Khalil Abdulla Khalil, Kamal Ali Salih
The aim of this study was to prepare specific F(ab')2 antivenom against Iraqi scorpion (Hottentotta saulcyi). Venom was obtained by electrical stimulation method, the scorpions venom storage capacity was 1.7 ± 0.4 mg and LD50 found to be 1.07 mg/kg by subcutaneous (s.c) route. Three local horses aging 3-4 years were selected for immunization. During the schedule each horse received 0.5-14 mg venom in 49 days by s.c route. The horses immune response was monitored by Ouchterlony double immunodiffusion method, however, older horse A showed the highest antibody titer (1:1056576)...
August 25, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/30150108/report-of-the-international-conference-on-manufacturing-and-testing-of-pluripotent-stem-cells
#6
Stewart Abbot, Francisca Agbanyo, Jan-Eric Ahlfors, Behnam A Baghbaderani, Shirley Bartido, Kapil Bharti, Carl Burke, Bjorn Carlsson, Joy Cavagnaro, Abla Creasey, David DiGiusto, Kathy Francissen, Andrew Gaffney, Christopher Goldring, Thorsten Gorba, Elwyn Griffiths, Tadaaki Hanatani, Takao Hayakawa, Tatsuo Heki, Karin Hoogendoorn, Shin Kawamata, Hironobu Kimura, Agnete Kirkeby, Ivana Knezevic, Jane Lebkowski, Stephen Lin, Shen Lin-Gibson, Anthony Lubiniecki, Orla O'Shea, Martin Pera, John Petricciani, Gary Pigeau, Anthony Ratcliffe, Yoji Sato, Gerald G Schumann, William Shingleton, Glyn Stacey Chair, Stephen Sullivan, Clive N Svendsen, Jean-Hugues Trouvin, Joris Vandeputte, Bao-Zhu Yuan, Kathryn Zoon
Sessions included an overview of past cell therapy (CT) conferences sponsored by the International Alliance for Biological Standardization (IABS). The sessions highlighted challenges in the field of human pluripotent stem cells (hPSCs) and also addressed specific points on manufacturing, bioanalytics and comparability, tumorigenicity testing, storage, and shipping. Panel discussions complemented the presentations. The conference concluded that a range of new standardization groups is emerging that could help the field, but ways must be found to ensure that these efforts are coordinated...
August 24, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/30146418/calibration-of-the-7th-british-working-standard-for-factors-ii-ix-and-x-concentrate
#7
Graham Roberts, Helen Wilmot, Thomas Dougall, Peter Rigsby, Elaine Gray
Seven laboratories from 5 different countries participated in the calibration of the 7th British Working Standard (BWS) for blood coagulation factors II, IX and X. The candidate, 15/182, was assayed for Factors II and X potencies against the 4th International Standard (IS) for Factors II and X, Concentrate (11/126) and for Factor IX potency against the 5th IS for Factor IX, Concentrate (14/148). Intra-laboratory GCVs for all 3 factors were less than 10%, with the majority less than 5%. Inter-laboratory GCVs were 3...
August 23, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/30126631/re-evaluating-the-ld50-requirements-in-the-codified-potency-testing-of-veterinary-vaccines-containing-leptospira-l-serogroup-icterohaemorrhagiae-and-l-serogroup-canicola-in-the-united-states
#8
Angela Walker, Renee Olsen, Mindy Toth, Geetha Srinivas
Approximately one-third of the reportable USDA Category D and E laboratory animals in the United States are expended on the potency testing of leptospiral vaccines by the codified hamster vaccination-challenge assay. Valid tests require ≥80% of challenge controls to succumb to disease and an LD50 between 10 and 10,000. This work evaluates the risk associated with the removal of LD50 limits; thereby, eliminating back-titration hamsters from in vivo potency assays for Leptospira (L.) serogroups Canicola and Icterohaemorrhagiae...
August 17, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/30100326/individual-variability-in-humoral-response-of-immunized-outbred-mice-and-cross-reactivity-with-prevalent-brazilian-neisseria-meningitidis-strains
#9
Gabriela Trzewikoswki de Lima, Elizabeth De Gaspari
No abstract text is available yet for this article.
September 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/30093175/report-of-the-international-conference-on-next-generation-sequencing-for-adventitious-virus-detection-in-biologicals
#10
Arifa S Khan, Luca Benetti, Johannes Blumel, Dieter Deforce, William M Egan, Ivana Knezevic, Philip R Krause, Laurent Mallet, Dietmar Mayer, Philip D Minor, Pieter Neels, Guanhua Wang
A fundamental aspect of biological product safety is to assure absence of adventitious agents in the final product. Next-generation or high-throughput sequencing (NGS/HTS) has recently demonstrated detection of viruses that were previously missed using the recommended routine assays for adventitious agent testing of biological products. This meeting was co-organized by the International Alliance for Biological Standardization (IABS) and the U.S. Food and Drug Administration (FDA) to assess the current status and discuss the readiness of NGS for adventitious virus detection in biologics...
September 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/30078661/proteome-wide-identification-of-epitope-based-vaccine-candidates-against-multi-drug-resistant-proteus-mirabilis
#11
Nosheen Ehsan, Sajjad Ahmad, Syed Sikander Azam, Thanyada Rungrotmongkol, Reaz Uddin
Proteus mirabilis is one of the important pathogens of urinary tract and exhibits resistance to multiple drugs. Development of vaccine tends to be the most promising and cost-effective remedy against the said pathogen. Herein, we implement a combinatorial approach for screening proteins harboring potential broad-spectrum antigenic epitopes in the proteome of P. mirabilis. The targets are host non-homologous, essential and virulent, and have localization in the extracellular and outer membrane. Immuno-informatics revealed antigenic, surface exposed and broad-spectrum B-cell derived T-cell epitopes for three membrane usher family candidates: AtfC, PMI2533 and PMI1466, which could evoke a substantial immune response...
September 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/30042006/evaluation-of-toll-like-receptor-4-expression-in-human-bone-marrow-mesenchymal-stem-cells-by-lipopolysaccharides-from-shigella
#12
Mohammad Reza Hashemzadeh, Mohamadreza Baghaban Eslaminejad, Reza Salman Yazdi, Reza Aflatoonian
Lipopolysaccharides (LPS) from gram negative bacteria stimulate toll-like receptor 4 (TLR4) expression in immune cells. Recent reports state that bone marrow-derived cells such as mesenchymal stem cells (MSCs) also express TLR proteins. Numerous researches have studied the effect of a number of LPSs on TLR4 expression, but no data exists on the effect of LPSs from different strains of one bacterial genus on TLR4 expression. In this study, we investigate the effects of various concentrations of LPS from different Shigella strains on TLR4 expression in human bone marrow (hBM)-MSCs...
September 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/30029931/baculovirus-expression-and-purification-of-peste-des-petits-ruminants-virus-nucleocapsid-protein-and-its-application-in-diagnostic-assay
#13
Suresh H Basagoudanavar, Madhusudan Hosamani, D Muthuchelvan, R P Singh, R Santhamani, B P Sreenivasa, P Saravanan, A B Pandey, R K Singh, Ramamurthy Venkataramanan
Peste-des-petits-ruminants (PPR) is a contagious and highly devastating disease of small ruminants. For control of endemic PPR, adequate supply of affordable and reliable diagnostics is critical for effective surveillance, along with the use of highly efficacious live vaccines that are currently available. The nucleocapsid (N) protein of PPR virus (PPRV) is an important candidate antigen for developing specific diagnostic, as it is a major viral protein being highly immunogenic and conserved among the structural proteins...
September 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/30017557/development-of-screening-method-for-intranasal-influenza-vaccine-and-adjuvant-safety-in-preclinical-study
#14
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...
September 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
#15
LETTER
Tuba Erdogan, Nazife Sule Yasar Bilge, Timucin Kasifoglu
No abstract text is available yet for this article.
September 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
#16
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...
September 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
#17
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...
September 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
#18
Antonella Di Paolo, Katia Forti, Lucia Anzalone, Sara Corneli, Martina Pellegrini, Giulio Severi, Monica Cagiola
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...
September 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
#19
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
#20
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
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