Cloning and expression of a novel synthetic gene containing VP1 and 3A in Bacillus subtilis as a vaccine candidate against foot-and-mouth disease virus
In this study the bioinformatics characteristics of VP1 [141–160 and 23–42] and 3A [21–35] of Iranian serotypes O, A and Asia 1 was obtained using on-line predicting software. Then the sequence VP1 [141–160]-GS-VP1 [23–42]-GS-3A [21–35]-GS were codon-optimized and cloned onpHT43shuttle vector and finally expressed in Bacillus subtilis WB600 strain. We could predict VP1 [141–160] as a B cell epitope, VP1 [23–42] as a CTL epitope and 3A [21–35] as a Th cell epitope. The 20KD recombinant protein expressed by Bacillus subtilis were detected by SDS-PAGE. The results showed that this recombinant protein had epi...
Source: Biologicals - May 16, 2019 Category: Biology Source Type: research
Aims and Scope/Editorial Board/Publishing Details
Publication date: May 2019Source: Biologicals, Volume 59Author(s): (Source: Biologicals)
Source: Biologicals - May 16, 2019 Category: Biology Source Type: research
A strategic road map to filing a Biologics License Application for a pluripotent stem cell derived therapeutic product
Publication date: Available online 30 April 2019Source: BiologicalsAuthor(s): Abla A. Creasey, Glyn Stacey, Kapil Bharti, Yoji Sato, Anthony Lubiniecki (Source: Biologicals)
Source: Biologicals - May 1, 2019 Category: Biology Source Type: research
Immunoglobulin G from single plasma donor in immune globulin intravenous causes false positive pyrogen test
Publication date: Available online 22 April 2019Source: BiologicalsAuthor(s): Clark Zervos, Thomas P. Zimmerman, Todd Willis, Greg Flexman, Jyoti Srivastava, Rebecca Silverstein, Melanie Williams, Pete Vandeberg, Jennifer L. Culp, Doug Burns, Vickie Barham, Amy Durham, David A. MalinzakAbstractA sudden, unprecedented failure of USP rabbit pyrogen tests for multiple 10% IGIV-C lots prompted a thorough investigation of the root cause for this phenomenon. All microbe-related testing, including Limulus amebocyte lysate test for endotoxin, proved negative, and no deficiencies were discovered in manufacturing. Plasma pool compos...
Source: Biologicals - April 23, 2019 Category: Biology Source Type: research
Comparison of different immunization routes on the immune responses induced by Mycobacterium tuberculosis ESAT-6/CFP-10 recombinant protein
Publication date: Available online 20 April 2019Source: BiologicalsAuthor(s): Mozhdeh Namvarpour, Majid Tebianian, Reza Mansouri, Seyyed Mahmoud Ebrahimi, Shiva KashkooliAbstractAccording to some difficulties against tuberculosis (TB) vaccination, development of new TB vaccines has been noted in recent years. Selection of proper route for vaccination is one of the most important factors for induction of good immune responses. Hence, in this study, the effects of different administration routes, including intranasal (I.N), subcutaneous (S.C) and intramuscular (I.M) on immune responses against Mycobacterium tuberculosis ESAT...
Source: Biologicals - April 21, 2019 Category: Biology Source Type: research
Correlation between the results of two analytical methods for measuring measles virus neutralizing antibodies in source plasma and therapeutic immunoglobulin products
Publication date: Available online 13 April 2019Source: BiologicalsAuthor(s): Jeungwoon Hong, Daegeun Kim, Younhee Won, Jungsoon Yoon, Kuk Jin Park, Jaetaek Oh, Chan-Wha KimAbstractPatients with primary immunodeficiency disorders are vulnerable to infectious diseases. Intravenous immunoglobulin (IVIG) therapeutic products manufactured from human plasma are employed widely to protect patients from pathogens such as measles virus, which causes a potentially fatal and contagious disease. Therefore, health authorities stipulate a minimum titer of measles neutralizing antibodies (mnAbs) in IVIG products to ensure efficient prot...
Source: Biologicals - April 14, 2019 Category: Biology Source Type: research
Use of a new RNA next generation sequencing approach for the specific detection of virus infection in cells
Publication date: Available online 13 April 2019Source: BiologicalsAuthor(s): Audrey Brussel, Kerstin Brack, Erika Muth, Rudolf Zirwes, Justine Cheval, Charles Hebert, Jean-Marie Charpin, Alice Marinaci, Benoit Flan, Horst Ruppach, Pascale Beurdeley, Marc EloitAbstractThe utilization of the current combination of in vitro, in vivo and PCR assays for the identification of adventitious viruses in production cells has a limited range of detection. While Next Generation Sequencing (NGS) has a broader breadth of detection, it is unable to differentiate sequences from replicating viruses versus background inert sequences. In ord...
Source: Biologicals - April 14, 2019 Category: Biology Source Type: research
Quality by Design characterization of the perfusion culture process for recombinant FVIII
Publication date: Available online 27 March 2019Source: BiologicalsAuthor(s): Yong Jae Kim, Sang Hoon Paik, Sang Kyul Han, Sunggeun Lee, Yoomin Jeong, Ji-youn Kim, Chan Wha KimAbstractA Quality by Design (QbD) concept was applied to characterize a cell culture process for production of the recombinant Factor VIII (rFVIII). We characterized the production bioreactor process and defined the design space by applying risk assessment to determine potential critical process parameters (CPPs) impacting critical quality attributes (CQAs). Characterization studies were subsequently performed using a qualified scaled-down model (SDM...
Source: Biologicals - March 28, 2019 Category: Biology Source Type: research
Estimation of potency of Hepatitis B immunoglobulin marketed in India to evaluate the manufacturer's production consistency: Role of National Control Laboratory
Publication date: Available online 25 March 2019Source: BiologicalsAuthor(s): Jaipal Meena, Shivani Sood, Neha Rani, Roshita Bisht, Manjula Kiran, Reba Chhabra, Surinder Singh, Subhash Chand (Source: Biologicals)
Source: Biologicals - March 25, 2019 Category: Biology Source Type: research
Modifications of recombinant monoclonal antibodies in vivo
Publication date: Available online 23 March 2019Source: BiologicalsAuthor(s): Hongcheng Liu, Christine Nowak, Rekha PatelAbstractTherapeutic recombinant monoclonal antibodies are subject to various modifications during cell culture, and to a lesser degree, during purification. These modifications are expected to remain relatively constant during storage with the protection of appropriate formulations. However, after administration to patients, the levels of modifications may vary over time in circulation, where the recombinant monoclonal antibodies are exposed to the physiological conditions. Scientific understanding of th...
Source: Biologicals - March 24, 2019 Category: Biology Source Type: research
A new recombinant rabies virus expressing a green fluorescent protein: A novel and fast approach to quantify virus neutralizing antibodies
Publication date: Available online 18 March 2019Source: BiologicalsAuthor(s): Shuyun Qin, Dmitriy Volokhov, Elvira Rodionova, Christoph Wirblich, Matthias J. Schnell, Vladimir Chizhikov, Alena DabrazhynetskayaAbstractThe Rapid Fluorescent Focus Inhibition Test (RFFIT) is a standard assay used to detect and assess the titers of rabies virus neutralizing antibodies (RVNA) in blood sera. To simplify the multistep RFFIT procedure by eliminating the immunostaining step, we generated a new recombinant RV expressing a green fluorescent protein (rRV-GFP) and assess its suitability for quantifying RVNA. We rescued the rRV-GFP virus...
Source: Biologicals - March 19, 2019 Category: Biology Source Type: research
Aims and Scope/Editorial Board/Publishing Details
Publication date: March 2019Source: Biologicals, Volume 58Author(s): (Source: Biologicals)
Source: Biologicals - March 15, 2019 Category: Biology Source Type: research
A structural in silico analysis of the immunogenicity of l-asparaginase from Escherichia coli and Erwinia carotovora
This study showed that there are no significant differences in the level of immunogenicity between both enzymes, while asparaginase from E. coli presented a higher relative frequency of allergenic epitopes. These results are consistent with previously published reports. However, from a structural point of view, in our knowledge, this is the first research describing the structural antigenic determinants that contribute to the hypersensibility response to this treatment. (Source: Biologicals)
Source: Biologicals - March 12, 2019 Category: Biology Source Type: research
Virus removal filtration of chemically defined Chinese Hamster Ovary cells medium with nanocellulose-based size exclusion filter
This article investigates the virus removal capacity of nanocellulose-based filter for upstream bioprocessing of chemically defined Chinese hamster ovary (CHO) cells medium containing Pluronic F-68 (PowerCHO™, Lonza) and supplemented with insulin-transferrin-selenium (ITS) at varying process parameters. Virus retention was assessed by spiking ITS-supplemented PowerCHO™ medium with small-size ΦX174 phage (28 nm) as a surrogate for mammalian parvoviruses. The nanocellulose-based size exclusion filter showed high virus retention capacity (over 4 log10) and high flow rates (around 180 L m−2 h−1). The filter ha...
Source: Biologicals - March 12, 2019 Category: Biology Source Type: research
Down-regulation of miR-122 after transplantation of mesenchymal stem cells in acute liver failure in mice model
This study investigated the correlation between the hepatic level of miR-122 and the extent of liver tissue regeneration in CCl4 induced liver injury mice model following transplantation of menstrual blood-(MenSCs) and bone marrow-derived stem cells (BMSCs). Hepatic miR-122 levels were significantly up-regulated following administration of CCl4 (P < 0.01). The significant positive correlations were observed between hepatic miR-122 and biochemical serum markers and the severity of liver injury in histopathological assessments (P < 0.01). Following stem cell therapy, all cell treated groups showed a significa...
Source: Biologicals - February 27, 2019 Category: Biology Source Type: research
