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    Validation and implementation of Planova™ BioEX virus filters in the manufacture of a new liquid intravenous immunoglobulin in China.
    Biologicals 2018 Feb 9. Epub 2018 Feb 9.
    Shandong Taibang Biological Products Co., Ltd., No. 14 East Hushan Road, Taian City, Shandong 271000, China. Electronic address:
    There is a continuous need to improve the viral safety of plasma products, and we here report the development and optimization of a manufacturing-scale virus removal nanofiltration step for intravenous immunoglobulin (IVIG) using the recently introduced Planova™ BioEX filter. IVIG throughput was examined for various operating parameters: transmembrane pressure, temperature, protein concentration, and prefiltration methods. The developed procedure was based on filtering undiluted process solution (50. Read More

    Evaluation of cellular immunogenicity of recombinant cytochrome p450 cyp141 protein of Mycobacterium tuberculosis in human and mouse model.
    Biologicals 2018 Feb 7. Epub 2018 Feb 7.
    Department of Microbiology and Immunology, Cellular and Molecular Research Center, Sharekord University of Medical Sciences, Sharekord, IR, Iran. Electronic address:
    Mycobacterium tuberculosis (Mtb) is still considered one of the unsolved problems for the World Health Organization Identifying and selecting an immunogenic antigen capable of generating specific immune responses is generally the goal of all studies being carried out in to designing new vaccines. Accordingly, the present study was conducted to evaluate the immunogenicity of a M. tuberculosis recombinant protein which exist in the regions of the bacterium genome and may be an immunogenic protein. Read More

    Sex bias in mouse humoral immune response to influenza vaccine depends on the vaccine type.
    Biologicals 2018 Feb 6. Epub 2018 Feb 6.
    Department of Physiology, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia. Electronic address:
    The study explored influence of biological sex on development of humoral immune response to seasonal trivalent whole inactivated virus (WIV) and split virus (SV) influenza vaccines in outbred Swiss mouse model. To this end, mice of both sexes were immunized with WIV (WIV mice) and SV vaccines (SV mice) and examined for specific antibody response. Irrespective of sex, total IgG and neutralizing antibody responses to distinct virus strains were weaker in SV than in WIV mice. Read More

    Comparison of reverse-transcriptase qPCR and droplet digital PCR for the quantification of dengue virus nucleic acid.
    Biologicals 2018 Feb 2. Epub 2018 Feb 2.
    Analytical R&D Department, Microbiology Characterization R&D Unit, Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy l'Etoile, France. Electronic address:
    Polymerase chain reaction (PCR) is an important molecular biology technique for in vitro amplification of nucleic acids. Reverse transcriptase quantitative PCR (RT-qPCR) and more recently reverse transcriptase digital droplet PCR (RT-ddPCR) have been developed for the quantification of nucleic acids. We developed an RT-ddPCR assay for the quantification of attenuated dengue virus serotype 2 nucleic acid and compared it with a routine RT-qPCR assay. Read More

    Distinct effect of fetal bovine serum versus follicular fluid on multipotentiality of human granulosa cells in in vitro condition.
    Biologicals 2018 Feb 2. Epub 2018 Feb 2.
    Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address:
    This study aimed to develop an appropriate medium for preservation of multipotentiality in human granulosa cells. To compare the possible effect of different media supplemented with follicular fluid or fetal bovine serum, granulosa cells were cultured in vitro over a period of 14 days. Stemness feature and any alteration in the cell phenotype were monitored using colony count assay and flow cytometry analysis by monitoring the expression of Oct3/4 and GATA-4 factors. Read More

    Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies.
    Biologicals 2018 Jan 25. Epub 2018 Jan 25.
    Zoetis, UK. Electronic address:
    Within the Innovative Medicines Initiative 2 (IMI 2) project VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing), a workshop has been organised to discuss ways of improving the design of multi-centre validation studies and use the data generated for product-specific validation purposes. Moreover, aspects of validation within the consistency approach context were addressed. This report summarises the discussions and outlines the conclusions and recommendations agreed on by the workshop participants. Read More

    Mass spectrometry analysis reveals differences in the host cell protein species found in pseudotyped lentiviral vectors.
    Biologicals 2018 Jan 17. Epub 2018 Jan 17.
    Division of Advanced Therapies, National Institute for Biological Standards and Control, Blanche Lane, Potters Bar, EN6 3QG, UK. Electronic address:
    Lentiviral vectors (LVs) have been successfully used in clinical trials showing long term therapeutic benefits. Studying the role of cellular proteins in lentivirus HIV-1 life cycle can help understand virus assembly and budding, leading to improvement of LV production for gene therapy. Lentiviral vectors were purified using size exclusion chromatography (SEC). Read More

    Biochemical characterization, stability, and pathogen safety of a new fibrinogen concentrate (fibryga).
    Biologicals 2018 Jan 11. Epub 2018 Jan 11.
    Octapharma Pharmazeutika Produktionsgesellschaft mbH, R&D Plasma Vienna, Oberlaaerstraße 235, 1100 Vienna, Austria.
    Fibrygais a new lyophilized fibrinogen concentrate for intravenous use for the treatment of congenital fibrinogen deficiency. fibrygais produced from pooled human plasma and the final product is characterized by high purity, integrity, and pathogen safety. Functional activity of fibrinogen was demonstrated by cross-linking studies and thromboelastometry; integrity of the fibrinogen molecule was demonstrated by size exclusion chromatography and the detection of only trace amounts of activation markers in the final product. Read More

    Directly injected native bone-marrow stem cells cannot incorporate into acetaminophen-induced liver injury.
    Biologicals 2018 Jan 6. Epub 2018 Jan 6.
    Cell-Based Therapies Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address:
    The paucity of liver donation highlights the use of cell-based strategies for end-stage liver failure. We recently showed that bone marrow-derived aggregates (BMDAs) can completely restore the hematopoietic system in gamma-irradiated mice. These aggregates are stem and progenitor cells in the bone marrow (BM), composed of both hematopoietic and non-hematopoietic lineages. Read More

    Humoral and cellular immune response in mice induced by the classical swine fever virus E2 protein fused to the porcine CD154 antigen.
    Biologicals 2018 Jan 5. Epub 2018 Jan 5.
    Animal Biotechnology Department, Center for Genetic Engineering and Biotechnology, POBox 6162, Havana 10600, Cuba.
    The development of subunit vaccines against classical swine fever is a desirable goal, because it allows discrimination between vaccinated and infected animals. In this study, humoral and cellular immune response elicited in inbred BALB/c mice by immunization with a recombinant classical swine fever virus (CSFV) E2 protein fused to porcine CD154 antigen (E2CD154) was assessed. This model was used as a predictor of immune response in swine. Read More

    Meeting report WHO informal consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 27-28 April 2017.
    Biologicals 2017 Dec 27. Epub 2017 Dec 27.
    Department of Medical Sciences, Ministry of Public Health, Tivanon Road, Nonthaburi 11000, Thailand. Electronic address:
    In April 2017, WHO convened an informal consultation to develop WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products. The objective of the meeting was to review the draft of WHO guidelines and the comments received from the public consultation. The guidelines were recognized by the participants as a tool for regulatory convergence and harmonization. Read More

    An ELISA for quantification of recombinant human EGF in production process samples, serum and urine.
    Biologicals 2018 Jan 12;51:12-17. Epub 2017 Dec 12.
    Monoclonal Antibody Production Department, Center for Genetic Engineering and Biotechnology, P.O. Box 6162, Havana 10600, Cuba.
    A sandwich enzyme-linked immunosorbent assay for quantifying a recombinant human Epidermal Growth Factor (rhEGF) protein used in a vacunal preparation is described. The protein was detected with high specificity in a short incubation time at elevated temperature, the assay showing a linear range between 0.0625 and 1 ng/mL. Read More

    Therapeutic monoclonal antibody N-glycosylation - Structure, function and therapeutic potential.
    Biologicals 2017 Nov 24. Epub 2017 Nov 24.
    Pharma Technical Development Analytics Biologics, Roche Diagnostics GmbH, Nonnenwald 2, D-82377, Penzberg, Germany.
    Therapeutic antibodies (IgG-type) contain several post-translational modifications (PTMs) whereby introducing a large heterogeneity, both structural and functional, into this class of therapeutics. Of these modifications, glycosylation in the fragment crystallizable (Fc) region is the most heterogeneous PTM, which can affect the stability of the molecule and interactions with Fc-receptors in vivo. Hence, the glycoform distribution can affect the mode of action and have implications for bioactivity, safety and efficacy of the drug. Read More

    High-level expression and immunogenicity of porcine circovirus type 2b capsid protein without nuclear localization signal expressed in Hansenula polymorpha.
    Biologicals 2018 Jan 7;51:18-24. Epub 2017 Dec 7.
    Department of Molecular Biology in College of Basic Medical Sciences and Institute of Pediatrics in First Hospital, Jilin University, Changchun 130021, China. Electronic address:
    Currently, porcine circovirus type 2b (PCV2b) is the dominant PCV2 genotype causing postweaning multisystemic wasting disease (PMWS) in pigs worldwide. Efforts have been made to develop various recombinant capsid proteins of PCV2b used in vaccines against PCV2b. However, the nuclear localization signal (NLS) of PCV2b capsid protein (CP) was found to inhibit the expression of the whole length capsid protein in E. Read More

    Stability of virus-like particles of red-spotted grouper nervous necrosis virus in the aqueous state, and the vaccine potential of lyophilized particles.
    Biologicals 2018 Jan 22;51:25-31. Epub 2017 Nov 22.
    Laboratory of Virology, College of Pharmacy, Chung-Ang University, 84 Heukseok-Ro, Dongjak-Gu, Seoul 06974, South Korea. Electronic address:
    Virus-like particles (VLPs) are multi protein complexes mimicking the structural properties of the native virus. The development of freeze-dried formulations of such complex protein structures remains a challenge. Red-spotted grouper nervous necrosis virus (RGNNV) causes mass mortality in fish culture, and RGNNV VLPs have been suggested to be promising vaccine candidates. Read More

    Screening for viral extraneous agents in live-attenuated avian vaccines by using a microbial microarray and sequencing.
    Biologicals 2018 Jan 11;51:37-45. Epub 2017 Nov 11.
    Virus Research and Development Laboratory, Department of Microbiological Diagnostics and Virology, Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark. Electronic address:
    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. We detected positive microarray signals for avian endogenous retrovirus EAV-HP and several viruses belonging to the Alpharetrovirus genus in all analyzed vaccines and SPF eggs. Read More

    Preparation and immunological evaluation of inactivated avian influenza virus vaccine encapsulated in chitosan nanoparticles.
    Biologicals 2018 Jan 8;51:46-53. Epub 2017 Nov 8.
    Analysis & Evaluation Department, Egyptian Petroleum Research Institute, 11727, Cairo, Egypt. Electronic address:
    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. Read More

    Successful removal of porcine circovirus-1 from immunoglobulin G formulated in glycine solution using nanofiltration.
    Biologicals 2018 Jan 7;51:32-36. Epub 2017 Nov 7.
    Research and Development Division, Japan Blood Products Organization, Hyogo, Japan; Manufacturing Technology Association of Biologics, Tokyo, Japan. Electronic address:
    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. Read More

    Analysis of the proficiency of single radial immunodiffusion assays for quality control of influenza vaccines in Korea.
    Biologicals 2017 Nov 28;50:137-140. Epub 2017 Oct 28.
    Vaccines Division, National Institute of Food and Drug Safety Evaluation, 187 Osongsaengmyeoung 2-ro, Osong-eup, Heungdoek-gu, Cheongju 28159, Republic of Korea. Electronic address:
    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. Read More

    A novel protocol to provide a suitable cardiac model from induced pluripotent stem cells.
    Biologicals 2017 Nov 27;50:42-48. Epub 2017 Oct 27.
    Department of Genetics, Faculty of Biological Sciences, Tarbiat Modares University, Tehran, Iran.
    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. Read More

    Characterisation of the site-specific monoPEGylated rhG-CSF analogue pegteograstim.
    Biologicals 2018 Jan 26;51:54-61. Epub 2017 Oct 26.
    Department of Biotechnology, College of Life Sciences and Biotechnology, Korea University, 136-701, Anam-dong, Seoungbuk-gu, Seoul, Republic of Korea. Electronic address:
    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. Read More

    Current status and future prospective of vaccine development against Echinococcus granulosus.
    Biologicals 2018 Jan;51:1-11
    Research Center for Pharmaceutical Nanotechnology, Biomedicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran; School of Advanced Biomedical Sciences, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Pharmaceutics, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address:
    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. Read More

    Binding and neutralizing anti-cytomegalovirus activities in immune globulin products.
    Biologicals 2017 Nov 10;50:35-41. Epub 2017 Oct 10.
    Plasma Derivatives Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, CBER, FDA, United States. Electronic address:
    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. Read More

    Oxidation of M252 but not M428 in hu-IgG1 is responsible for decreased binding to and activation of hu-FcγRIIa (His131).
    Biologicals 2017 Nov 5;50:125-128. Epub 2017 Oct 5.
    Pharma Technical Development Analytics Biologics, F. Hoffmann-La Roche Ltd., 4070 Basel, Switzerland.
    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). Read More

    Biophysical characterization and structure of the Fab fragment from the NIST reference antibody, RM 8671.
    Biologicals 2017 Nov 29;50:27-34. Epub 2017 Sep 29.
    Biomolecular Measurement Division, National Institute of Standards & Technology, Rockville, MD 20850, USA; Institute for Bioscience and Biotechnology Research, 9600 Gudelsky Drive, Rockville, MD 20850, USA. Electronic address:
    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. Read More

    Evaluation of the combined effects of pegylation and glycosylation on the stability of erythropoietin using a stability-indicating SE-HPLC.
    Biologicals 2017 Nov 27;50:129-136. Epub 2017 Sep 27.
    Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Egypt.
    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. Read More

    Validation of a PCR coupled to a microarray method for detection of mycoplasma in vaccines.
    Biologicals 2017 Nov 23;50:55-62. Epub 2017 Sep 23.
    Analytical Research and Development, Sanofi Pasteur, 69280 Marcy l'Etoile, France.
    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. Read More

    Differentiation of mesenchymal stem cells -derived trabecular meshwork into dopaminergic neuron-like cells on nanofibrous scaffolds.
    Biologicals 2017 Nov 21;50:49-54. Epub 2017 Sep 21.
    Department of Medical Biotechnology and Nanotechnology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran; Cancer and Gene Therapy Research Center, Zanjan University of Medical Sciences, Zanjan, Iran. Electronic address:
    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. Read More

    Scientific considerations for the regulatory evaluation of cell therapy products.
    Biologicals 2017 Nov 6;50:20-26. Epub 2017 Sep 6.
    World Health Organization, Switzerland. Electronic address:
    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. Read More

    Biochemical comparison of four commercially available human α-proteinase inhibitors for treatment of α-antitrypsin deficiency.
    Biologicals 2017 Nov 4;50:63-72. Epub 2017 Sep 4.
    CSL Behring, Kankakee, IL, USA. Electronic address:
    Intravenous therapy with purified plasma-derived alpha-proteinase inhibitor (α-PI) concentrates is the only specific treatment for α-PI deficiency. For the therapy to be safe and efficacious, α-PI concentrates should be highly pure and contain high amounts of functional protein. This study compared the four plasma-derived α-PI products commercially available in Europe (Respreeza, Prolastin, Alfalastin, Trypsone) by biochemical methods with respect to function, purity, structure, and chemical modifications. Read More

    Eradicating hepatitis B virus: The critical role of preventing perinatal transmission.
    Biologicals 2017 Nov 2;50:3-19. Epub 2017 Sep 2.
    University of California School of Medicine, San Francisco, CA, 94143-0134, United States.
    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. Read More

    Improved stem cell therapy of spinal cord injury using GDNF-overexpressed bone marrow stem cells in a rat model.
    Biologicals 2017 Nov 26;50:73-80. Epub 2017 Aug 26.
    Department of Stem Cells Biology, Stem Cell Technology Research Center, Tehran, Iran. Electronic address:
    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. Read More

    A phase 1 study to evaluate the safety and pharmacokinetics of MEDI8852, an anti-influenza A monoclonal antibody, in healthy adult volunteers.
    Biologicals 2017 Nov 23;50:81-86. Epub 2017 Aug 23.
    MedImmune, One MedImmune Way, Gaithersburg, MD 20878, United States. Electronic address:
    MEDI8852 is an IgG1 kappa monoclonal antibody that is being developed to treat patients hospitalized with influenza A. We evaluated the safety and tolerability, pharmacokinetics, and anti-drug antibodies (ADA) of a single intravenous dose of MEDI8852 in healthy adult volunteers (NCT02350751). Forty subjects were randomized to receive either MEDI8852 (250, 750, 1,500, or 3000 mg) (n = 32) or placebo (n = 8) on day 1. Read More

    Evaluation of marker gene expression as a potential predictive marker of leukopenic toxicity for inactivated influenza vaccines.
    Biologicals 2017 Nov 31;50:100-108. Epub 2017 Aug 31.
    Department of Safety Research on Blood and Biological Products, National Institute of Infectious Disease, 4-7-1 Gakuen, Musashi-Murayama, Tokyo 208-0011, Japan.
    The leukopenic toxicity test (LTT) is used to evaluate the safety and lot-to-lot consistency of influenza hemagglutinin split vaccine (HAv) and is included in the Japanese Minimum Requirements for Biological Products. LTT assesses the reduced leukocyte levels in murine peripheral blood after HAv administration. However, they require large numbers of animals, and therefore it would be beneficial to develop a more accurate and sensitive alternative method. Read More

    Towards a peptide-based vaccine against Shigella sonnei: A subtractive reverse vaccinology based approach.
    Biologicals 2017 Nov 18;50:87-99. Epub 2017 Aug 18.
    Computational Biology Lab, National Center for Bioinformatics (NCB), Faculty of Biological Sciences, Quaid-i-Azam University, Islamabad, Pakistan. Electronic address:
    Shigella sonnei is one of the major causes of shigellosis in technically advanced countries and reports of its unprecedented increase are published from the Middle East, Latin America, and Asia. The pathogen exhibits resistance against first and second line antibiotics which highlights the need for the development of an effective broad-spectrum vaccine. A computational based approach comprising subtractive reverse vaccinology was used for the identification of potential peptide-based vaccine candidates in the proteome of S. Read More

    Cross-reactivity and inhibition myotoxic effects induced by Bothrops snake venoms using specific polyclonal anti-BnSP7 antibodies.
    Biologicals 2017 Nov 16;50:109-116. Epub 2017 Aug 16.
    Faculdade de Medicina, Universidade Federal de Uberlândia, Av. Pará, 1720, Campus Umuarama, Bloco 2U, Uberlândia, MG, 38400-902, Brazil. Electronic address:
    Polyclonal antibodies raised in Balb-c mice against BnSP-7, a Lys-49 phospholipase A2, were used to measure cross reactivity against other snake venoms. Using ELISA, these antibodies were able to recognize PLAs isoforms present in venoms of botropic snakes at 1:6400, 1:3200 and 1:100 ratios (w/w). These antibodies highly recognized proteins of low molecular weight (∼14,000) from crude snake venom Bp and Bm by Western Blotting. Read More

    Interlaboratory study for the establishment of Brazilian Bothrops Reference Venom and Antivenom for potency evaluation of Bothrops antivenom.
    Biologicals 2017 Sep 14;49:1-5. Epub 2017 Aug 14.
    Departamento de Imunologia, Instituto Nacional de Controle de Qualidade em Saúde, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.
    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. Read More

    Design and synthesis of multiple antigenic peptides and their application for dengue diagnosis.
    Biologicals 2017 Sep 18;49:81-85. Epub 2017 Aug 18.
    Department of Biochemistry, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India. Electronic address:
    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. Read More

    Recovery and assessment of leukocytes from LR Express filters.
    Biologicals 2017 Sep 31;49:15-22. Epub 2017 Jul 31.
    Department of Basic Biomedical Sciences, Sanford School of Medicine, University of South Dakota, Vermillion, SD 57069, United States. Electronic address:
    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. Read More

    Alkaline hydrolysis to increase the selectivity of colorimetric determination of polysorbate.
    Biologicals 2017 Sep 29;49:6-14. Epub 2017 Jul 29.
    Shire, Analytical Development, Vienna A-1220, Austria. Electronic address:
    Here, we describe a straightforward sample pretreatment step for the colorimetric cobaltthiocyanate determination of polysorbate, which circumvents the assay's shortcomings due to interference of protein and does not require complex instrumentation. Protein-containing test samples are hydrolyzed with strong alkali at 100 °C, neutralized and clarified by filtration before applying the colorimetric assay. The modified method performs with appropriate accuracy and precision, allowing specific polysorbate measurement in the presence of Triton X-100 during virus inactivation, determination of residual amounts of polysorbate in the final products and measurement of polysorbate 80 in final formulated products. Read More

    Comparative efficacy of chemical stabilizers on the thermostabilization of a novel live attenuated buffalopox vaccine.
    Biologicals 2017 Sep 25;49:39-45. Epub 2017 Jul 25.
    Division of Virology, ICAR- Indian Veterinary Research Institute, Mukteswar Campus, Nainital [District], Uttarakhand 263 138, India.
    In the present investigation, the thermostability of a live attenuated buffalopox vaccine prepared with an indigenous baffalopox virus isolate (BPXV Vij/96) and freeze-dried under conventional lyophilizing conditions is described. Three different stabilizer combinations like LS (lactalbumin hydralysate + sucrose), LHT (lactalbumin hydralysate + Trehalose dihydrate) and TAA (Trehalose dihydrate + l- Alanine + l-Histidine) were used to prepare the vaccine. The study indicated that the LS stabilizer was found to be the stabilizer of choice followed by LHT and TAA for buffalopox vaccine at all temperatures studied. Read More

    Schmallenberg virus, an emerging viral pathogen of cattle and sheep and a potential contaminant of raw materials, is detectable by classical in-vitro adventitious virus assays.
    Biologicals 2017 Sep 24;49:28-32. Epub 2017 Jul 24.
    BioReliance Ltd, Todd Campus, West of Scotland Science Park, Glasgow, G20 OXA, United Kingdom. Electronic address:
    Emerging viruses, as potential contaminants of raw materials used in the manufacture of biologicals represent a challenge in the safety testing of biopharmaceutical products intended for human or veterinary use. Here, we report the challenge of an in vitro adventitious virus platform used in safety testing of biologicals, where a broad panel of detector cell lines was challenged to provide evidence that Schmallenberg virus is detectable by a classical reporting endpoint of cytopathic effect with Vero, BHK-21 and CHO-K1 detector cells, within typical in vitro assay timescales. We conclude that Schmallenberg virus is robustly detectable by classical in vitro viral biosafety assays. Read More

    Determination of acceptance criteria and sample sizes for accelerated stability comparability studies for biologics.
    Biologicals 2017 Sep 22;49:46-50. Epub 2017 Jul 22.
    MedImmune LLC, Gaithersburg, MD 20878, United States.
    Changes of manufacturing processes are common. It is required by the regulatory agencies that manufacturers establish adequate and appropriate comparability between pre-change and post-change products. The goals of comparability assessments are to demonstrate the comparability and consistency of product quality before and after change and to demonstrate that the changes do not have an adverse effect on safety and efficacy of the drug products. Read More

    Adjuvantation of inactivated Foot and Mouth Disease Virus vaccine with IL-15 expressing plasmid improves the immune response in Guinea Pigs.
    Biologicals 2017 Sep 19;49:23-27. Epub 2017 Jul 19.
    ICAR-Indian Veterinary Research Institute, Hebbal, Bengaluru 560024, India. Electronic address:
    Foot and mouth disease is a highly contagious disease affecting cloven footed animals. Vaccination using inactivated virus is followed to control the disease. As the immune response conferred by the inactivated vaccine is short lived, there is a need for an alternate vaccine with increased duration of immunity. Read More

    Efficacy of a nonadjuvanted recombinant FeLV vaccine and two inactivated FeLV vaccines when subject to consistent virulent FeLV challenge conditions.
    Biologicals 2017 Sep 19;49:76-80. Epub 2017 Jul 19.
    Merial, Research and Development, Lyon Gerland Laboratories, 254 rue Marcel Mérieux, 69007, Lyon, France.
    The purpose of this study was to compare the efficacy of three FeLV vaccines, under identical conditions in a laboratory challenge model that closely mimics natural infection. Four groups of cats (n = 20 per group) were administered two doses of vaccine, 21 days apart, starting at 9-10 weeks of age (PurevaxFeLV, VersifelFeLV, Nobivacfeline 2-FeLV, and a placebo). Cats were challenged 3 weeks later with a virulent, heterologous FeLV isolate. Read More

    A comparative study of phenotypic and genotypic first- and second-line drug resistance testing of Mycobacterium tuberculosis.
    Biologicals 2017 Sep 15;49:33-38. Epub 2017 Jul 15.
    Department of Mycobacteriology and Pulmonary Research, Pasteur Institute of Iran, Tehran, Iran; Microbiology Research Center (MRC), Pasteur Institute of Iran, Tehran, Iran.
    This study aimed to evaluate the frequency of resistance to first- and second-line drugs using phenotypic and genotypic methods and its correlation with resistance-linked mutations in Mycobacterium tuberculosis (M. tb) isolated in Iran. Three different methods, including the indirect proportion method(PM), direct and indirect nitrate reductase assay(NRA), and direct sequencing were used to assess drug resistance. Read More

    Nano-encapsulation of chicken immunoglobulin (IgY) in sodium alginate nanoparticles: In vitro characterization.
    Biologicals 2017 Sep 8;49:69-75. Epub 2017 Jul 8.
    Department of Biology, Faculty of Basic Science, Imam Hossein University, Tehran, Iran.
    Controlled delivery of therapeutic agents by alginate nanoparticles became an attractive issue in the gastric organ. Some therapeutic agents such as proteins could not tolerate in severe condition in the gastrointestinal tract. In the present study, four concentrations of a specific IgY as a prophylactic agent against E. Read More

    Determination of immune status in dogs against CPV-2 by recombinant protein based latex agglutination test.
    Biologicals 2017 Sep 6;49:51-56. Epub 2017 Jul 6.
    Division of Medicine, Indian Veterinary Research Institute, Izatnagar Bareilly, 243122, India.
    Canine parvoviral enteritis is a highly contagious viral illness caused by canine parvovirus-2 (CPV-2) which affects puppies of mainly 6-20 weeks of age. Vaccination is pivotal in preventing and controlling CPV-2 infection. Determination of antibody status is a critical determinant for successful vaccination. Read More

    Production of a broad-specificity monoclonal antibody and application as a receptor to detection amatoxins in mushroom.
    Biologicals 2017 Sep 5;49:57-61. Epub 2017 Jul 5.
    Hebei North University, Laboratory Animal Center of Hebei North University, Zhangjiakou, 075000, China.
    In this study, we report the production of a monoclonal broad-specificity monoclonal antibody (mAb) specific for amatoxins and development of an indirect competitive immunoassay for detection of amatoxins in mushroom samples. In the assay, the complete antigen (α-amanitin-OVA) was used as coating antigen, and amatoxins as competitor competes with coating antigen to bind with mAb. Using this approach, The half-maximum inhibition concentrations (IC) of α-amanitin, β-amanitin and γ-amanitin, and limits of detection (LODs, IC) were 66. Read More

    Stem cells from human-exfoliated deciduous teeth reduce tissue-infiltrating inflammatory cells improving clinical signs in experimental autoimmune encephalomyelitis.
    Biologicals 2017 Sep 28;49:62-68. Epub 2017 Jun 28.
    Universidade Federal de Juiz de Fora, Juiz de Fora, Brazil. Electronic address:
    Stem cells from human exfoliated deciduous teeth (SHED) have great therapeutic potential and here, by the first time, we evaluated their immunomodulatory effect on experimental model of autoimmune encephalomyelitis (EAE). Specifically, we investigated the effect of SHED administration on clinical signs and cellular patterns in EAE model using Foxp3 GFP + transgenic mice (C57Bl/6-Foxp3GFP). The results showed that SHED infusion ameliorated EAE clinical score with reduced number of infiltrating IFN-γCD8, IL-4CD8, IFN-γCD4and IL-4CD4T cells into the central nervous system (CNS). Read More

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