Utility of reference materials for Zika Virus nucleic acid testing
Publication date: Available online 2 July 2019Source: BiologicalsAuthor(s): Sarah L. Kempster, Thomas Dougall, Clare Morris, Gabriel Gonzalez-Escobar, Neil Almond, Rob AndersonAbstractThe emergence of Zika virus (ZIKV) in the Americas has resulted in increased nucleic acid amplification testing (NAT) of clinical samples and blood donations. New molecular diagnostic assays have been developed resulting in a corollary requirement for ZIKV reference material. To address this we have produced and calibrated two African lineage ZIKV reference materials: a highly concentrated secondary standard (NIBSC: 16/110) and a lower concen...
Source: Biologicals - July 3, 2019 Category: Biology Source Type: research
Trabecular meshwork mesenchymal stem cell transplantation improve motor symptoms of parkinsonian rat model
Publication date: Available online 29 June 2019Source: BiologicalsAuthor(s): Hossein Mostafavi, Leila Ghassemifard, Ali Rostami, Mohsen Alipour, Samad NadriAbstractStem cell transplantation is a new therapeutic strategy in the treatment of neurodegenerative disorders such as Parkinson's disease (PD). Therefore, in this study, the therapeutic effects of Trabecular Meshwork Mesenchymal Stem Cells (TM-MSCs) transplantation, as a new source of mesenchymal stem cells, were evaluated in the animal model of PD.After the development and confirmation of hemi-parkinsonian rats by administration of 6-hydroxy dopamine (6-OHDA) and apo...
Source: Biologicals - June 30, 2019 Category: Biology Source Type: research
Achieving scientific and regulatory success in implementing non-animal approaches to human and veterinary rabies vaccine testing: A NICEATM and IABS workshop report
Publication date: Available online 27 June 2019Source: BiologicalsAuthor(s): Rebecca Poston, Richard Hill, Cynthia Allen, Warren Casey, Donna Gatewood, Robin Levis, Laurent Mallet, Dean Smith, Geetha Srinivas, Catrina Stirling, David AllenAbstractThis two-day workshop, co-sponsored by NICEATM and IABS-NA, brought together over 60 international scientists from government, academia, and industry to advance alternative methods for human and veterinary Rabies Virus Vaccine (RVV) potency testing. On day one, workshop presentations focused on regulatory perspectives related to in vitro potency testing, including recent additions...
Source: Biologicals - June 27, 2019 Category: Biology Source Type: research
Self-reported satisfaction of patients receiving omalizumab for severe allergic asthma in Malta
Publication date: Available online 18 June 2019Source: BiologicalsAuthor(s): Caroline Gouder, Simon Gouder, Stephen MontefortAbstractTreatment satisfaction is of utmost importance for ensuring adherence. Omalizumab is administered long-term if effective and well-tolerated in a hospital setting. The aim was to evaluate treatment satisfaction with omalizumab in Malta and to identify factors that may influence patients’ satisfaction.A questionnaire was distributed to all asthmatic adult patients receiving omalizumab for at least one year. The questionnaire included demographic data, dosing regimen, asthma control test and t...
Source: Biologicals - June 19, 2019 Category: Biology Source Type: research
Generation of acid resistant virus like particles of vaccine strains of foot-and-mouth disease virus (FMDV)
Publication date: Available online 17 June 2019Source: BiologicalsAuthor(s): P.R. Deepak, P. Saravanan, J.K. Biswal, S.H. Basagoudanavar, H.J. Dechamma, V. Umapathi, B.P. Sreenivasa, R.P. Tamilselvan, N. Krishnaswamy, I. Zaffer, A. SanyalAbstractFoot-and-mouth disease (FMD) is a contagious viral disease affecting cloven hoofed livestock. Insect cell expressed virus like particles (VLPs) are potential alternative to overcome the limitations of inactivated vaccine. However, at pH < 6.5, virus particles disassociate into pentameric structure resulting in loss of antigenicity. Accordingly, we generated seven mutant VLPs co...
Source: Biologicals - June 18, 2019 Category: Biology Source Type: research
Combining secukinumab and fingolimod to successfully treat ankylosing spondylitis and multiple sclerosis – A novel approach
Publication date: Available online 13 June 2019Source: BiologicalsAuthor(s): Muhammad K. Nisar (Source: Biologicals)
Source: Biologicals - June 14, 2019 Category: Biology Source Type: research
Generic immune complex assay for detection of murine anti-drug-antibodies in complex with human IgG
Publication date: Available online 11 June 2019Source: BiologicalsAuthor(s): Lykke Boysen, Anne M.E. Sprinkel, Brian Lauritzen, Jens Breinholt, Jens Lykkesfeldt, Birgitte M. Viuff, Lone H. LandsyAbstractRapid and versatile methods are needed for evaluation of immunogenicity in early safety studies. The present work presents a generic, simple and easy to use sandwich enzyme-linked immunosorbent assay for quasi-quantitative measurement of circulating immune complexes (CICs) formed by anti-drug antibodies (ADAs) in complex with human IgG in mouse plasma. The assay is suitable for evaluating the presence of in vivo formed CICs...
Source: Biologicals - June 12, 2019 Category: Biology Source Type: research
Evaluation of environment safety of a Japanese encephalitis live attenuated vaccine
Publication date: Available online 7 June 2019Source: BiologicalsAuthor(s): Xinyu Liu, Lili Jia, Kaixiao Nie, Danhua Zhao, Rui Na, Hongshan Xu, Gong Cheng, Junzhi Wang, Yongxin Yu, Yuhua LiAbstractJE vaccination is the most effective and economical method of preventing JE. A live attenuated JE vaccine has been widely used in many countries since 1989, playing an important role in controlling JE outbreaks. However, whether the large-scale use of the live attenuated JE vaccine will lead to the dissemination of the vaccine virus in the environment and whether reversion of the neuroattenuation of the virus will occur during th...
Source: Biologicals - June 7, 2019 Category: Biology Source Type: research
Octanorm [cutaquig®], a new immunoglobulin (human) subcutaneous 16.5% solution for injection (165 mg/mL) – Biochemical characterization, pathogen safety, and stability
Publication date: Available online 1 June 2019Source: BiologicalsAuthor(s): Nicola Gelbmann, Alfred Zöchling, Alexander Pichotta, Torben Schmidt, Andrej Murányi, Thomas Ernegger, Katharina Pock, Jürgen RömischAbstractOctanorm (marketed as cutaquig® in Canada and US [2018] and registered in several European countries [2019]) is a new immunoglobulin subcutaneous 16.5% liquid for the treatment of patients with primary immune deficiency (PID) and secondary immune deficiency (SID) depending on country's specific indications.Octanorm contains ≥96% human IgG and is characterized by especially low concentrations of polymers...
Source: Biologicals - June 1, 2019 Category: Biology Source Type: research
The INN global nomenclature of biological medicines: A continuous challenge
Publication date: Available online 23 May 2019Source: BiologicalsAuthor(s): James S. Robertson, Wai-Keung Chui, Armando A. Genazzani, Sarel F. Malan, Ana López de la Rica Manjavacas, Gilles Mignot, Robin Thorpe, Raffaella Balocco, Menico RizziAbstractMedicines are assigned International Nonproprietary Names (INN) by the World Health Organization (WHO), pursuing the aim to increase patient safety. Following scientific developments in drug discovery and biotechnology, the number of biological medicines is constantly growing and a surge in INN applications for them has been observed. Pharmacologically active biological subst...
Source: Biologicals - May 24, 2019 Category: Biology Source Type: research
Meeting report narcolepsy and pandemic influenza vaccination: What we know and what we need to know before the next pandemic? A report from the 2nd IABS meeting
Publication date: Available online 23 May 2019Source: BiologicalsAuthor(s): Kathryn Edwards, Germaine Hanquet, Steve Black, Emmanuel Mignot, Christopher Jankosky, Tom Shimabukuro, Elizabeth Miller, Hanna Nohynek, Pieter NeelsAbstractA group of scientific and public health experts and key stakeholders convened to discuss the state of knowledge on the relationship between adjuvanted monovalent inactivated 2009 influenza A H1N1 vaccines used during the 2009 influenza pandemic and narcolepsy. There was consensus that an increased risk of narcolepsy was consistently observed after Pandemrix (AS03-adjuvanted) vaccine, but simila...
Source: Biologicals - May 24, 2019 Category: Biology Source Type: research
Quantitation of residual sodium dodecyl sulfate in meningococcal polysaccharide by gas chromatography-mass spectrometry
Publication date: Available online 22 May 2019Source: BiologicalsAuthor(s): Niraj Shende, Abhijeet Karale, Preeti Marathe, Sourish Chakraborty, Asha D. Mallya, Rajeev M. DhereAbstractSodium dodecyl sulfate (SDS) is a commonly used surfactant in protein solubilization and also during the polysaccharide purification. A GC-MS method has been developed to quantitate residual SDS in meningococcal polysaccharide serogroups A,C,W,Y and X circumventing the need of spectroscopic assays and HPLC based methods which are either unstable or requires the confirmation by MS. The developed method is based on quantitative conversion of SDS...
Source: Biologicals - May 22, 2019 Category: Biology Source Type: research
Choice of parvovirus model for validation studies influences the interpretation of the effectiveness of a virus filtration step
Publication date: Available online 16 May 2019Source: BiologicalsAuthor(s): Thomas Nowak, Birgit Popp, Nathan J. RothAbstractDifferent parvoviruses are used interchangeably as models in validation studies to demonstrate effective clearance of small viruses by filtration in the manufacturing of biotherapeutics.The aim of these experiments was to determine if filtration of different parvoviruses (canine parvovirus [CPV], minute virus of mice [MVM], and porcine parvovirus [PPV]) results in similar virus retention.While filtration with a Planova™ 20 N filter (mean pore size: 19 ± 2 nm) completely removed PPV and MVM...
Source: Biologicals - May 18, 2019 Category: Biology Source Type: research
The development and establishment of the 1st WHO BKV International Standard for nucleic acid based techniques
We report on the evaluation of two lyophilised candidate cell culture derived, whole virus preparations, undertaken by 33 expert laboratories. By employing the principles of biological standardisation, we show improved agreement across laboratories, demonstrating the suitability of either candidate for use as a primary order calibrant. Candidate 14/212 was established by the WHO ECBS with an assigned potency of 7.2 log10 International Units/mL intended for the calibration of BKV secondary reference materials. (Source: Biologicals)
Source: Biologicals - May 18, 2019 Category: Biology Source Type: research
Potency test to discriminate between differentially over-inactivated rabies vaccines: Agreement between the NIH assay and a G-protein based ELISA
In this study we have generated several non-conform vaccine lots by an excessive inactivation with β-propiolactone (BPL) and assessed the capacity of both tests to detect the corresponding consequences. Excessive BPL inactivation causes G-protein unfolding, altering in turn viral morphology and the continuity of the G-protein layer in the viral particle. Both the NIH and the ELISA tests were able to monitor the consequences of excessive inactivation in a similar manner. Of note, the experimental error of the ELISA test was well below that of the NIH test. These results increase the prospect that the ELISA test could be co...
Source: Biologicals - May 18, 2019 Category: Biology Source Type: research
