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Biologicals: Journal of the International Association of Biological Standardization

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https://www.readbyqxmd.com/read/29132963/screening-for-viral-extraneous-agents-in-live-attenuated-avian-vaccines-by-using-a-microbial-microarray-and-sequencing
#1
Majken Lindholm Olesen, Lotte Leick Jørgensen, Merete Blixenkrone-Møller, Eva Sandberg, Peer Lyng Frandsen, Erik Østergaard, Eva Rauhe Bækdahl, Helena Fridholm, Anders Fomsgaard, Maiken Worsøe Rosenstierne
The absence of extraneous agents (EA) in the raw material used for production and in finished products is one of the principal safety elements related to all medicinal products of biological origin, such as live-attenuated vaccines. The aim of this study was to investigate the applicability of the Lawrence Livermore Microbial detection array version 2 (LLMDAv2) combined with whole genome amplification and sequencing for screening for viral EAs in live-attenuated vaccines and specific pathogen-free (SPF) eggs...
November 10, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29126666/preparation-and-immunological-evaluation-of-inactivated-avian-influenza-virus-vaccine-encapsulated-in-chitosan-nanoparticles
#2
Samah H Mohamed, Abdel Satar Arafa, Wesam H Mady, Hanan A Fahmy, Lamiaa M Omer, Rania E Morsi
Efficacy maximization of inactivated avian influenza vaccine using safe adjuvants was investigated. Chitosan nanoparticles were prepared by ionic gelation method with average size of 150 nm and their Zeta potential was 11.5 mV. After encapsulation of avian influenza vaccine, the average size was 397 nm and Zeta potential was 4.29 mV. The highest HI antibody titer results were shown in chicken group vaccinated with inactivated avian influenza virus AIV-chitosan followed by the group vaccinated with inactivated AIV-chitosan nanoparticles then the group vaccinated with oil inactivated AIV vaccine, on using chicken antigen at 2 weeks post second vaccination...
November 8, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29122439/successful-removal-of-porcine-circovirus-1-from-immunoglobulin-g-formulated-in-glycine-solution-using-nanofiltration
#3
Rong-Mei Bao, Akemi Shibuya, Takashi Uehira, Tetsuo Sato, Takeru Urayama, Kaoru Sakai, Mikihiro Yunoki
Porcine circovirus (PCV) is a potentially harmful virus that has been shown to contaminate biological products. The virus is resistant to many inactivation and/or removal procedures performed during manufacturing. Anion exchange chromatography has been shown to be useful for PCV type 1 (PCV1) removal; however, reduction of PCV1 using methods such as heat inactivation, low pH, nanofiltration, UV-C, and gamma irradiation has not been successful. Therefore, in this study, we evaluate various conditions for process solutions during nanofiltration using PCV1...
November 6, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29100669/current-status-and-future-prospective-of-vaccine-development-against-echinococcus-granulosus
#4
REVIEW
Mohammad Mostafa Pourseif, Gholamali Moghaddam, Nazli Saeedi, Abolfazl Barzegari, Jaber Dehghani, Yadollah Omidi
Cystic echinococcosis (CE) is one of the most important zoonotic parasite diseases in human, livestock, and wildlife worldwide. Development of effective vaccines against CE appears to be the most promising strategy to control this infectious disease. Use of potential livestock and canine vaccines against the larval and adult stage of E. granulosus life cycle may be the key to the production of powerful vaccines. Some progress has been accomplished in the development of vaccines against hydatidosis using empirical approaches, while such immunotherapies often fail to induce adequate immune responses...
October 31, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29111376/analysis-of-the-proficiency-of-single-radial-immunodiffusion-assays-for-quality-control-of-influenza-vaccines-in-korea
#5
Yejin Choi, Sunmi Lee, Seong Yi Kwon, Younghee Lee, Yong Keun Park, Sang Ja Ban
Influenza vaccine potency, which is determined by quantitatively measuring the content of Hemagglutinin (HA), is an essential index representing the efficacy of the vaccine. Standardization of the single radial immunodiffusion (SRID) assay, a method for measuring HA content, and proficiency of the testing institutions are crucial for influenza vaccine quality control. Herein, we assessed the proficiency of SRID assays at the National Control Laboratory (NCL) of Korea and several vaccine manufacturers. Eight laboratories participated in this study, and the proficiencies of all laboratories yielded satisfactory results in overall SRID assays...
October 27, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29111375/a-novel-protocol-to-provide-a-suitable-cardiac-model-from-induced-pluripotent-stem-cells
#6
Mahsa Rasekhi, Masoud Soleimani, Behnaz Bakhshandeh, Majid Sadeghizadeh
Cumulative evidence has proven the safety, feasibility and efficacy of stem cell therapy for cardiomyocyte replacement in heart failure treatment. In contrast to embryonic stem cells, induced pluripotent stem cells (iPS cells) provide a route to the production of patient-specific stem cell lines with no ethical concerns. Recent studies have revealed that myogenic transcription factors activated the expression of conserved microRNAs (miRNAs), such as mir-1, that 'fine-tuned' the output of the transcriptional networks...
October 27, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29107446/characterisation-of-the-site-specific-monopegylated-rhg-csf-analogue-pegteograstim
#7
Jeungwoon Hong, Byoungju Lee, Kwanyub Kang, Seung-Hoon Lee, Jaehwan Ryu, Gangsoo Jung, Jaetaek Oh, Eui-Cheol Jo, Chan-Wha Kim
We describe the characterisation of a novel monoPEGylated recombinant human granulocyte colony-stimulating factor analogue, pegteograstim (Neulapeg), prepared by site-specific 20 kDa maleimide-PEG conjugation. An additional cysteine was inserted between Gly136 and Ala137 of filgrastim (methionyl human granulocyte colony-stimulating factor) for site-specific PEGylation, and Cys18 of filgrastim was replaced with Ser18 to prevent unwanted PEGylation. Pegteograstim was produced by Escherichia coli and purified by cation exchange chromatography, and its structural, physicochemical, biological and immunological properties were investigated...
October 26, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29029807/binding-and-neutralizing-anti-cytomegalovirus-activities-in-immune-globulin-products
#8
Xiao Wang, Yanqun Xu, Dorothy E Scott, Haruhiko Murata, Evi B Struble
Congenital infection as well as infection of immunocompromised individuals by cytomegalovirus (CMV) can be associated with significant morbidity, mortality, and long-term adverse health outcomes. Assessment of anti-viral activity using appropriate assays is essential for ensuring safe and efficacious use of therapeutic CMV immune globulin (IG) products. In this study, we used commercial ELISA kits to compare anti-CMV antibody binding activity and avidity for lots of CMV-specific and normal IG products available in the US market...
October 10, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28988621/oxidation-of-m252-but-not-m428-in-hu-igg1-is-responsible-for-decreased-binding-to-and-activation-of-hu-fc%C3%AE-riia-his131
#9
Florian Cymer, Marco Thomann, Harald Wegele, Cecile Avenal, Tilman Schlothauer, Daniel Gygax, Hermann Beck
Oxidation of monoclonal therapeutic antibodies (mAbs) can affect binding to Fc-receptors and potentially influence pharmacokinetics or effector functions like e.g. antibody dependent cellular phagocytosis (ADCP). Recently, it has been demonstrated that binding to FcγRIIa (H131) is affected by methionine oxidation of the Fc-portion but it is currently unknown which methionine is responsible for decreased binding. We separated an oxidized IgG1 monoclonal antibody based on the oxidation state of methionine 252 and analyzed fractionated material in receptor binding experiments as well as in functional (cell-based) assays...
October 4, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28965821/biophysical-characterization-and-structure-of-the-fab-fragment-from-the-nist-reference-antibody-rm-8671
#10
Ioannis Karageorgos, Elyssia S Gallagher, Connor Galvin, D Travis Gallagher, Jeffrey W Hudgens
Monoclonal antibody pharmaceuticals are the fastest-growing class of therapeutics, with a wide range of clinical applications. To assure their safety, these protein drugs must demonstrate highly consistent purity and stability. Key to these objectives is higher order structure measurements validated by calibration to reference materials. We describe preparation, characterization, and crystal structure of the Fab fragment prepared from the NIST Reference Antibody RM 8671 (NISTmAb). NISTmAb is a humanized IgG1κ antibody, produced in murine cell culture and purified by standard biopharmaceutical production methods, developed at the National Institute of Standards and Technology (NIST) to serve as a reference material...
September 28, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28958787/evaluation-of-the-combined-effects-of-pegylation-and-glycosylation-on-the-stability-of-erythropoietin-using-a-stability-indicating-se-hplc
#11
Heba S Abed, Medhat A Al-Ghobashy, Faten A Fathalla, Maissa Y Salem
Recombinant human erythropoietin (rhEPO) is a commonly used biopharmaceutical for the treatment of anemia-associated disorders. Epogen; glycosylated erythropoietin (G-EPO) has short half-life and poor stability. Pegylated Epogen (Peg-G-EPO) was introduced to the market to overcome these limitations. The combined effects of pegylation and glycosylation on the stability of Peg-G-EPO was studied. Determination of Peg-G-EPO in the presence of its degradation products was achieved using SE-HPLC. The assay was validated according to ICH guidelines over concentration range of 50...
September 25, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28951118/validation-of-a-pcr-coupled-to-a-microarray-method-for-detection-of-mycoplasma-in-vaccines
#12
Eric Abachin, Marine Marius, Stéphanie Falque, Julien Arnaud, Valérie Detrez, Sandy Imbert, Laurent Mallet, Thierry Bonnevay
The revised section of the European, United States, and Japan Pharmacopeias on mycoplasma testing provided guidance for the set up and validation of a nucleic acid amplification technique (NAT) as an alternative method to agar culture and indicator cell culture compendial methods. The CytoInspect™ method, based on Polymerase Chain Reaction (PCR) coupled to microarray analysis, has been selected for detection and identification of mycoplasma in vaccines. To replace compendial methods, the alternative method must demonstrate equivalence in both limit of detection (LOD) and specificity compared with compendial methods...
September 23, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28942114/differentiation-of-mesenchymal-stem-cells-derived-trabecular-meshwork-into-dopaminergic-neuron-like-cells-on-nanofibrous-scaffolds
#13
Simin Jamali, Hossein Mostafavi, Ghasem Barati, Mehdi Eskandari, Samad Nadri
Parkinson's disease (PD) is a neurodegenerative disorder of the brain which is produced by the damage to dopaminergic neurons. Stem cell transplantation with a nanofibrous scaffold is one of the encouraging strategies for Parkinson's disease therapy. In this study, human mesenchymal stem cells (MSCs) from eye trabecular meshwork (TM) were differentiated into dopaminergic neurons on nanofibrous scaffold. After Trabecular meshwork biopsy, MSCs were isolated, cultivated on Poly-l-Lactide Acid (PLLA) nanofibrous scaffold (fabricated by electrospinning methods) and treated with medium containing DMEM supplemented with RA, IBMX and forskolin for 7 days...
September 20, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28888427/scientific-considerations-for-the-regulatory-evaluation-of-cell-therapy-products
#14
REVIEW
John Petricciani, Takao Hayakawa, Glyn Stacey, Jean-Hugues Trouvin, Ivana Knezevic
Cell therapy involves the administration of a viable somatic cell preparation to a patient for the treatment of a disease or traumatic damage. Because cell therapies are complex and very different from traditional biological products, they present significant challenges for regulatory authorities, manufacturers, developers, health care providers, and patients involved in their application. Like other emerging areas of biomedical research and development, there are many issues where regulatory views and decisions among countries and regions may differ due to minimal scientific evidence to support safety and efficacy, and lack of experience with these novel treatments...
September 6, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28882403/biochemical-comparison-of-four-commercially-available-human-%C3%AE-1-proteinase-inhibitors-for-treatment-of-%C3%AE-1-antitrypsin-deficiency
#15
David J Boerema, Bo An, Ronak P Gandhi, Randy Papineau, Ed Regnier, Anna Wilder, Alexander Molitor, Andrew P Tang, Scott M Kee
Intravenous therapy with purified plasma-derived alpha1-proteinase inhibitor (α1-PI) concentrates is the only specific treatment for α1-PI deficiency. For the therapy to be safe and efficacious, α1-PI concentrates should be highly pure and contain high amounts of functional protein. This study compared the four plasma-derived α1-PI products commercially available in Europe (Respreeza, Prolastin, Alfalastin, Trypsone) by biochemical methods with respect to function, purity, structure, and chemical modifications...
September 4, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28870397/eradicating-hepatitis-b-virus-the-critical-role-of-preventing-perinatal-transmission
#16
REVIEW
Cladd E Stevens, Pearl Toy, Saleem Kamili, Patricia E Taylor, Myron J Tong, Guo-Liang Xia, Girish N Vyas
Prevention of hepatitis B virus (HBV) transmission from infected mothers to their newborns is critical to HBV control and eventual eradication. Mother-to-child perinatal transmission causes the highest chronic carrier rate (>85%) with a high rate of subsequent chronic liver disease and hepatocellular carcinoma. This risk is reduced by 90% with HBV vaccine given along with hepatitis B immune globulin (HBIG) starting at birth. New analyses of our data from US trials of HBIG and HBV vaccine in high-risk infants revealed better efficacy with yeast-recombinant vaccine than plasma-derived vaccine, especially in preventing late onset infections, with evidence that vaccine prevented transmission of maternal HBV infection with the glycine to arginine mutation in surface antigen codon 145 (sG145R)...
September 1, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28851622/improved-stem-cell-therapy-of-spinal-cord-injury-using-gdnf-overexpressed-bone-marrow-stem-cells-in-a-rat-model
#17
Mostafa Shahrezaie, Reyhaneh Nassiri Mansour, Bahare Nazari, Hadi Hassannia, Fatemeh Hosseini, Hossein Mahboudi, Mohamad Eftekhary, Mousa Kehtari, Arash Veshkini, Abbas Ahmadi Vasmehjani, Seyed Ehsan Enderami
The use of stem cell base therapy as an effective strategy for the treatment of spinal cord injury (SCI) is very promising. Although some strategy has been made to generate neural-like cells using bone marrow mesenchymal stem cells (BMSCs), the differentiation strategies are still inefficiently. For this purpose, we improved the therapeutic outcome with utilize both of N-neurotrophic factor derived Gelial cells (GDNF) gene and differentiation medium that induce the BMSCs into the neural-like cells. The differentiated GDNF overexpressed BMSCs (BMSCs-GDNF) were injected on the third day of post-SCI...
August 26, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28818424/interlaboratory-study-for-the-establishment-of-brazilian-bothrops-reference-venom-and-antivenom-for-potency-evaluation-of-bothrops-antivenom
#18
Humberto Pinheiro de Araújo, Elizabeth Porto Reis Lucas, Wlamir Corrêa de Moura, Celia de Fátima Barbosa, Raquel Joane Rodrigues, Josefina Farina Morais, Joseana Zaja Almada, Barbara Carino Guimarães, Antonio Eugenio Castro Cardoso de Almeida, Maria Aparecida Affonso Boller
A collaborative study was performed for the establishment of the 5th lot of Brazilian Bothrops Reference Venom and the 1st lot of Brazilian Bothrops Reference Antivenom. All Brazilian manufacturers of Antibothrops Immunoglobulins and the National Control Laboratory participated of the study. The declared potency of the 5th lot of the Bothrops Reference Venom is 40.29 μg/0.5 ml, and the potency of the 1st lot of Bothrops Reference Antivenom is 6.51 mg/ml. For the potency evaluation of Bothrops Reference Venom the inter assay precision (gCV) was 3...
September 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28818423/design-and-synthesis-of-multiple-antigenic-peptides-and-their-application-for-dengue-diagnosis
#19
Reeta Rai, Sameer Dubey, K V Santosh, Ashutosh Biswas, Vinit Mehrotra, D N Rao
Major difficulty in development of dengue diagnostics is availability of suitable antigens. To overcome this, we made an attempt to develop a peptide based diagnosis which offers significant advantage over other methods. With the help of in silico methods, two epitopes were selected from envelope protein and three from NS1 protein of dengue virus. These were synthesized in combination as three multiple antigenic peptides (MAPs). We have tested 157 dengue positive sera confirmed for NS1 antigen. MAP1 showed 96...
September 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28774790/recovery-and-assessment-of-leukocytes-from-lr-express-filters
#20
Abby K Wegehaupt, Ellen K Roufs, Cory R Hewitt, Marisela L Killian, Oxana Gorbatenko, Cynthia M Anderson, M Scott Killian
Leukocytes, or white blood cells, are used for a variety of investigational purposes and they offer advantages over laboratory-adapted cell lines. Leukocytes that are typically discarded by blood banks during the collection of red blood cells, platelets, and plasma can often be obtained for research use. However, the available leukocytes are frequently contained within a blood filtration device, such as the Terumo LR Express (TLRE) filter. In this study, procedures were evaluated for the ability to elute viable leukocytes from TLRE filters...
September 2017: Biologicals: Journal of the International Association of Biological Standardization
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