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Biologicals: Journal of the International Association of Biological Standardization

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https://read.qxmd.com/read/30755369/characterization-of-inflammatory-bowel-disease-management-by-vedolizumab-and-concomitant-treatments-in-real-life-clinical-practice
#1
Tero Ylisaukko-Oja, Saku Torvinen, Jaakko Aaltonen, Heikki Nuutinen, Timo Blomster, Airi Jussila, Markku Pajala, Kimmo Salminen, Veikko Moilanen, Kalle Hakala, Mikko Kellokumpu, Kari Toljamo, Henna Rautiainen, Juha Kuisma, Markku Peräaho, Pauliina Molander, Jouni Silvennoinen, Ville Liukkonen, Hans Henricson, Jyrki Tillonen, Mirva Esterinen, Christian Nielsen, Eija Hirsi, Margus Lääne, Ulla-Maija Suhonen, Ilkka Vihriälä, Petri Mäkelä, Mika Puhto, Jari Punkkinen, Hannu Sulonen, Sauli Herrala, Jari Jokelainen, Klaus Tamminen, Taina Sipponen
Limited data is available on vedolizumab combination therapies in real-world clinical practice. Here, we evaluated the concomitant corticosteroid, immunosuppressive, and 5-aminosalicylic acid utilization of inflammatory bowel disease (IBD) patients treated with vedolizumab in a nationwide, retrospective, non-interventional, multi-centre chart review study. All adult patients from 27 Finnish gastroenterology centres with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) who had at least one vedolizumab infusion since it's availability in Finland were included in the study...
February 9, 2019: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30744947/demonstration-of-functional-similarity-of-a-biosimilar-adalimumab-sb5-to-humira-%C3%A2
#2
JongAh Joanne Lee, Junmo Yang, Changsoo Lee, Youngjin Moon, Sehee Ahn, Jiyoon Yang
A biosimilar is a biological medicinal product that is highly similar to an authorized biological product in terms of quality, biological activity, safety and efficacy. SB5 was developed by Samsung Bioepis as a biosimilar referencing adalimumab, and was authorized by the European Commission (EC) in August 2017 (Imraldi® ). Extensive characterization studies were performed to demonstrate functional similarity of SB5 to reference adalimumab (Humira® , AbbVie Inc. and AbbVie Deutschland GmbH & Co. KG). SB5 and Humira® showed highly similar soluble TNF-α binding and neutralizing activity, as well as transmembrane TNF-α binding activity and reverse signaling induced in the membrane TNF-α expressing cell line...
February 7, 2019: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30718130/performance-characteristics-of-a-fast-real-time-pcr-assay-for-hepatitis-b-virus-dna-quantification
#3
Anny Armas Cayarga, Yenitse Perea Hernández, Yaimé J González González, Juan E Figueredo Lago, Irinia Y Valdivia Álvarez, Ivonne Gómez Cordero, Niurka Santos Hernández, Héctor Vega Sánchez, Deyanira La Rosa Hernández, Ernesto L Martínez Pérez
Detection of hepatitis B virus (HBV) DNA is particularly important for detection of early acute and of occult HBV infection. On the other hand, HBV DNA detection and quantification are essential to diagnose and treat chronic HBV infection. In this study, we evaluated the performance of the real-time PCR SUMASIGNAL VHB (un paso) (Immunoassay Center, Cuba). The clinical and analytical specificity of the assay was 100%. Intra-assay and inter-assay coefficients of variation ranged from 0.50 to 2.53% and from 1...
February 1, 2019: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30704904/in-depth-site-specific-o-glycosylation-analysis-of-therapeutic-fc-fusion-protein-by-electron-transfer-higher-energy-collisional-dissociation-mass-spectrometry
#4
Noritaka Hashii, Junya Suzuki, Hisatoshi Hanamatsu, Jun-Ichi Furukawa, Akiko Ishii-Watabe
Unexpected O-glycosylations, including O-xylosylations and mucin-type O-glycosylations, have been reported in recent glycosylation analyses of Fc-fusion proteins produced in mammalian cell expression systems. This observation suggests that therapeutic proteins with novel structures can undergo unintended O-glycosylations, having implications regarding their efficacy and safety. Therefore, the implementation of O-glycosylation analysis during product developmental is essential. However, detail site-specific O-glycosylation analysis is difficult because no consensus sequence for mucin-type O-glycosylations is known, and O-glycopeptides often contain multiple or continuous glycosylation sites...
January 28, 2019: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30661901/virus-removal-robustness-of-ion-exchange-chromatography
#5
Kang Cai, Jennifer Anderson, Joshua D Orchard, Christopher D Afdahl, Matthew Dickson, Yuling Li
Virus removal by ion exchange chromatography enhances the safety profile of therapeutic protein products. The robustness of virus removal depends on electrostatic binding between virus and oppositely charged chromatography media. However, model retrovirus Xenotropic Murine Leukemia Virus (XMuLV) binding remains robust even when virus and media are both positively charged. We investigated this counter-intuitive phenomenon using side-by-side comparison of virus-media binding behavior of XMuLV versus parvovirus, two viruses very different in size and structure but comparable in isoelectric point...
January 17, 2019: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30661900/use-of-hexon-as-an-antigen-for-the-production-of-monoclonal-antibodies-capable-of-detecting-multiple-adenovirus-types
#6
Tatyana A Timoshicheva, Yana A Zabrodskaya, Edward Ramsay, Irina V Amosova
In this work, monoclonal antibodies to the adenovirus protein hexon were produced, and their biological and diagnostic properties were characterized. The specific activities of the new monoclonal antibodies, with respect to various adenovirus types, were studied by enzyme-linked immunosorbent assay, indirect immunofluorescence, and western blot analysis. The data demonstrate the potential of the monoclonal antibodies developed, namely 4B7 and 6B12, for use in the development of modern diagnostic assays.
January 17, 2019: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30660437/method-for-the-determination-of-residual-formaldehyde-in-an-inactivated-zika-vaccine-formulated-with-aluminum-hydroxide-gel
#7
Nao Ogasawara, Masafumi Misaki, Satoshi Adachi
A simple method for the determination of low levels of residual formaldehyde in an inactivated Zika vaccine formulated with aluminum hydroxide gel was developed for the assessment of drug product quality. Formaldehyde was reacted with 2,4-dinitrophenylhydrazine (DNPH) and the derivatized product was detected by HPLC with an UV detector at 360 nm. The derivatization reaction could be carried out in a 2-mL HPLC vial and the sample was analyzed directly. The method was fully validated according to the International Conference on Harmonization Q2 guidelines...
January 16, 2019: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30655169/control-of-therapeutic-igg-antibodies-galactosylation-during-cultivation-process-and-its-impact-on-igg1-fc%C3%AE-r-interaction-and-adcc-activity
#8
Vladimir Simonov, Sergey Ivanov, Maxim Smolov, Svetlana Abbasova, Aleksandr Piskunov, Dmitry Poteryaev
Therapeutic monoclonal antibodies (mAbs) are within the fastest growing group of pharmaceuticals on the global market. IgG1 subclass is the most potent effector in Fc-related functions. The N-linked glycosylation of mAbs Fc-domain significantly influences its therapeutic activity and the presence of this modification is largely dependent on producer cell and parameters of manufacturing process. Here we examined and characterized cell culture conditions that determine during cultivation selective changes in galactose content of a model therapeutic mAb IgG1, trastuzumab biosimilar...
January 15, 2019: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30639575/establishment-of-the-first-national-reference-standard-for-insulin-lispro-report-of-a-collaborative-study
#9
Gurminder Bindra, Gaurav Pratap Singh Jadaun, Shruti Dixit, Vandana Saklani, Zafar Abbas, Parveen Jain, Kim B Dancheck, Matthew W Borer, Meena Kumari, Charu Mehra Kamal, Renu Jain, Surinder Singh
The present study was aimed to establish the First National Reference Standard (NRS) for Insulin lispro to allow stakeholders including manufacturer's laboratories, drug testing laboratories, drug regulatory authorities and academic institutions to demonstrate accuracy of the test results and to enable comparison and validation of analytical methods. The candidate standard for Insulin lispro was evaluated in a collaborative study to assign the vial content in order to serve it as NRS to support the Indian Pharmacopoeia (IP) monograph...
January 10, 2019: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30635155/an-elisa-using-a-recombinant-chimera-of-protective-antigen-and-lethal-factor-for-serodiagnosis-of-cutaneous-anthrax-in-india
#10
Anshul Varshney, Nidhi Puranik, Manoj Kumar, Vijai Pal, J Padmaja, A K Goel
In this study, an ELISA was developed for simultaneous detection of antibodies against both the important toxins of B. anthracis i.e. protective antigen (PA) and lethal factor (LF). A chimera of PA and LF was made by fusion and cloned and expressed in E. coli. The purified recombinant protein was used in plate ELISA for serodiagnosis of anthrax. The chimera could detect antibodies against both the toxins of Bacillus anthracis. The human serum samples (n = 98) collected from anthrax endemic and non-endemic areas were tested employing ELISA...
January 8, 2019: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30553568/interlaboratory-comparison-about-feasibility-of-insoluble-particulate-matter-test-for-injections-with-reduced-test-volume-in-light-obscuration-method
#11
Akira Harazono, Hiroko Shibata, Masato Kiyoshi, Takashi Muto, Jun Fukuda, Tetsuo Torisu, Satoshi Saitoh, Hirotaka Nishimura, Susumu Uchiyama, Akiko Ishii-Watabe
Insoluble particulate matter test for injections in pharmacopoeia is mandatory for parenteral drug products. In this test using light obscuration, four measurements of at least 5-mL are required. Since therapeutic protein injections of low dosage volumes are getting more popular, reduction of test volumes is desired. In this collaborative study, the impact of lower measurement volume on the accuracy and precision of particle count was evaluated using 2, 5, 10, and 25-μm polystyrene count standards for the validity of test with reduced sample volumes...
December 12, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30553567/comparison-of-different-pcr-protocols-and-respective-primer-sets-from-pool-of-tams-1-gene-for-diagnosis-of-calf-theileriosis-from-semi-arid-india
#12
Sanjhi Paliwal, Daya Shanker, Vikrant Sudan, Sanjeev Kumar, Mukesh Srivastava, Kapil Kumar Gupta
The polymorphic nature of Theileria annulata merozoite surface antigen (TAMS 1) attributes to limitation in PCR based detection of various T. annulata genotypes present in different geographical domains across the globe. Multiple reports of failure of detection of tropical theileriosis using classical N516/517 primer set in the studied area were noticed. Hence, three single PCR protocols using N516/517, TAMS F/R and NTA F/R primer sets encoding different portions of TAMS 1 gene and two nested protocols, using combinations of these three primers, were compared to find out the most suitable primer set for diagnosis of calf theileriosis in studied area...
December 12, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30502020/evaluation-of-two-who-first-international-standards-for-vi-polysaccharide-from-citrobacter-freundii-and-salmonella-enterica-subspecies-enterica-serovar-typhi
#13
Fang Gao, Carolyn Swann, Peter Rigsby, Sjoerd Rijpkema, Kay Lockyer, Alastair Logan, Barbara Bolgiano
Numerous Vi capsular polysaccharide (Vi PS) conjugate vaccines to protect young children and infants from Typhoid are either licensed or under development. These vaccines are evaluated by laboratory methods to ensure their potency and that quality requirement are met. International Standard (IS) preparations of Vi PS are needed to calibrate and harmonise these assays. Twenty laboratories from 12 countries participated in a collaborative study to evaluate two candidate ISs: Citrobacter freundii Vi PS (NIBSC code 12/244) and Salmonella enterica serovar Typhi Vi PS (16/126)...
November 27, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30477957/the-evaluation-of-an-immunoperoxidase-assay-applicable-in-antiviral-drug-screening
#14
Liqian Zhu, Liai Huang, Aiping Wang, Qingmei Li, Junqing Guo, Li Wang, Gaiping Zhang
Bovine viral diarrhea virus (BVDV) fall into cytopathic (CP) and noncytopathic (NCP) biotypes, based on their ability to kill cultured cells. NCP-BVDV can not be titrated by conventional means as used for CP-BVDV, which has impeded the identification of antiviral drugs targeting NCP-BVDV virus strains. In this study, the application of an immunoperoxidase assay in the screening of antiviral drugs was tested using two known BVDV inhibitors, ribavirin and ammonium chloride (NH4Cl). Phospholipase C inhibitor U73122 was identified to affect BVDV infection by using this immunoperoxidase assay...
November 23, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30458978/development-and-validation-of-a-robust-multiplex-serological-assay-to-quantify-antibodies-specific-to-pertussis-antigens
#15
Gowrisankar Rajam, George Carlone, Ellie Kim, Jin Choi, Simon Paulos, SoHee Park, Amilia Jeyachandran, Yamini Gorantla, Emily Wong, Amit Sabnis, Peter Browning, Rita Desai, Conrad P Quinn, Jarad Schiffer
Despite wide spread vaccination, the public health burden of pertussis remains substantial. Current acellular pertussis vaccines comprise upto five Bordetella pertussis (Bp) antigens. Performing an ELISA to quantify antibody for each antigen is laborious and challenging to apply to pediatric samples where serum volume may be limited. We developed a microsphere based multiplex antibody capture assay (MMACA) to quantify antibodies to five pertussis antigens; pertussis toxin, pertactin, filamentous hemagglutinin and fimbrial antigens 2/3, and adenylate cyclase toxin in a single reaction (5-plex) with a calibrated reference standard, QC reagents and SAS® based data analysis program...
November 17, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30454953/avian-leukosis-virus-subgroup-j-as-a-contaminant-in-live-commercially-available-poultry-vaccines-distributed-in-nigeria
#16
Ismaila Shittu, Adeyinka J Adedeji, Pam D Luka, Olayinka O Asala, Nancy M Sati, Ijeoma O Nwagbo, Chinonyerem N Chinyere, Oluwadamilola O Arowolo, Jolly A Adole, Paulinus Emennaa, Paul A Abdu, Tony M Joannis
Globally, vaccines are used to prevent and control the menace of infectious diseases in livestock with some reported to be inadvertently contaminated with extraneous agents (EAs). With the aim of screening and characterizing for some selected EAs, 44 live viral poultry vaccines were randomly selected based on availability. The vaccines comprised 14 manufacturers in 10 different countries including Nigeria were screened by Polymerase Chain Reaction. In 9% (4/44) of the vaccines, contamination with only avian leukosis virus (ALV) subgroup J (ALV-J) was recorded...
November 16, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30447860/determination-of-residual-poly-diallyldimethylammonium-chloride-pdadmac-in-monoclonal-antibody-formulations-by-size-exclusion-chromatography-and-evaporative-light-scattering-detector
#17
Mehdi Khodadadian, Maryam Ghassemi, Hossein Behrouz, Shayan Maleknia, Fereidoun Mahboudi
The cationic polyelectrolyte pDADMAC is widely used in biopharmaceutical industry as a flocculating agent to enhance clarification throughput and downstream filtration operations. Due to the possible toxicity, pDADMAC should be assessed for an acceptable residual level to ascertain the safety of the product to patients. The strong protein-polyelectrolyte interaction, however, can negatively affect sensitivity and accuracy of measurements. This paper reports on the application of size exclusion (SE) chromatography coupled to evaporative light scattering detector (ELSD) to the quantitative determination of pDADMAC in monoclonal antibody formulations and in process intermediates during downstream purification...
November 14, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30431001/human-single-chain-variable-fragment-antibody-expressed-in-e-coli-with-optimal-in-vitro-cross-neutralizing-and-no-enhancing-activity
#18
Surachet Benjathummarak, Chonlatip Pipattanaboon, Khwanchit Boonha, Waranya Wongwit, Pongrama Ramasoota, Pannamthip Pitaksajjakul
Single chain fragment variable (scFv) is a small molecule antibody comprising of only the variable region of heavy and light chain responsible for antigen binding. For dengue disease, the Fc region of antibody molecule was reported to be involved with dengue complication caused by Antibody-dependent enhancement (ADE). We attempted to produce small molecule scFv human monoclonal antibody (HuMAb), which lacking the Fc portion to eliminate the ADE effect of the IgG. This scFv antibody was produced in Escherichia coli...
November 2018: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30309678/the-combination-of-retinoic-acid-and-estrogen-can-increase-germ-cells-genes-expression-in-mouse-embryonic-stem-cells-derived-primordial-germ-cells
#19
Neda Eskandari, Meysam Hassani Moghaddam, Mohammad Ali Atlasi, Javad Amini Mahabadi, Aliakbar Taherian, Hossein Nikzad
Generation of germ cells from embryonic stem cells in vitro could have great application for treating infertility. The temporal expression profile of several genes was expressed at different stages of germ cell development and examined in differentiation the mouse embryonic stem cells. Cells were treated in three groups of control, with 10-8  M of all-trans retinoic acid and the combination of 10-9  M of 17β-Estradiol and retinoic acid for 7, 12, 17 or 22 days. Quantitative RT-PCR and Immunofluorescent were used to investigate the possible inductive effects of estrogen on mouse embryonic stem cell-derived primordial germ cells...
November 2018: Biologicals: Journal of the International Association of Biological Standardization
https://read.qxmd.com/read/30201529/establishment-of-the-first-international-standard-for-human-anti-typhoid-capsular-vi-polysaccharide-igg
#20
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)...
November 2018: Biologicals: Journal of the International Association of Biological Standardization
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