Prevalence of oncogenic Human papillomavirus and genetic diversity in the L1 gene of HPV16 HPV 18 HPV31 and HPV33 found in women from Vojvodina Province Serbia
Publication date: Available online 20 February 2019Source: BiologicalsAuthor(s): Gordana Kovacevic, Vesna Milosevic, Petar Knezevic, Aleksandra Knezevic, Ivana Knezevic, Jelena Radovanov, Natasa Nikolic, Aleksandra Patic, Vladimir Petrovic, Ivana Hrnjakovic Cvjetkovic, Ljiljana StanisicAbstractThe main purpose of this paper is to estimate the pre-vaccination prevalence of 12 hrHPV types among 564 women from Vojvodina province (Serbia). The corrected contingency coefficient (Ccorr) was used to estimate the importance of association of examined HPV types and cytological diagnosis. The highest association with the abnormal cy...
Source: Biologicals - February 20, 2019 Category: Biology Source Type: research
Characterization of inflammatory bowel disease management by vedolizumab and concomitant treatments in real-life clinical practice
Publication date: Available online 10 February 2019Source: BiologicalsAuthor(s): 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 TillonenAbstractLimited 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 inflamma...
Source: Biologicals - February 11, 2019 Category: Biology Source Type: research
Demonstration of functional similarity of a biosimilar adalimumab SB5 to Humira®
Publication date: Available online 8 February 2019Source: BiologicalsAuthor(s): JongAh Joanne Lee, Junmo Yang, Changsoo Lee, Youngjin Moon, Sehee Ahn, Jiyoon YangAbstractA 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...
Source: Biologicals - February 8, 2019 Category: Biology Source Type: research
Performance characteristics of a fast real-time PCR assay for hepatitis B virus DNA quantification
In conclusion, the SUMASIGNAL VHB (un paso) is a sensitive, specific, precise and accurate assay for the quantification of serum and plasma HBV DNA. Thus, this simple and fast real-time PCR test can be used as an aid in diagnosing an HBV infection and monitoring drug efficacy. (Source: Biologicals)
Source: Biologicals - February 2, 2019 Category: Biology Source Type: research
In-depth site-specific O-Glycosylation analysis of therapeutic Fc-fusion protein by electron-transfer/higher-energy collisional dissociation mass spectrometry
This study is the first to report these unexpected O-xylosylations and mucin-type O-glycosylations in this therapeutic fusion protein. Mammalian-cell production of therapeutic fusion proteins that contain novel structures may require exhaustive O-glycosylation analysis to ensure their quality, efficacy, and safety. (Source: Biologicals)
Source: Biologicals - January 29, 2019 Category: Biology Source Type: research
Virus removal robustness of ion exchange chromatography
Publication date: Available online 18 January 2019Source: BiologicalsAuthor(s): Kang Cai, Jennifer Anderson, Joshua D. Orchard, Christopher D. Afdahl, Matthew Dickson, Yuling LiAbstractVirus 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 c...
Source: Biologicals - January 18, 2019 Category: Biology Source Type: research
Aims and Scope/Editorial Board/Publishing Details
Publication date: January 2019Source: Biologicals, Volume 57Author(s): (Source: Biologicals)
Source: Biologicals - January 17, 2019 Category: Biology Source Type: research
Use of hexon as an antigen for the production of monoclonal antibodies capable of detecting multiple adenovirus types
Publication date: Available online 17 January 2019Source: BiologicalsAuthor(s): Tatyana A. Timoshicheva, Yana A. Zabrodskaya, Edward Ramsay, Irina V. AmosovaAbstractIn 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 t...
Source: Biologicals - January 17, 2019 Category: Biology Source Type: research
Method for the determination of residual formaldehyde in an inactivated Zika vaccine formulated with aluminum hydroxide gel
Publication date: Available online 17 January 2019Source: BiologicalsAuthor(s): Nao Ogasawara, Masafumi Misaki, Satoshi AdachiAbstractA 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 accordi...
Source: Biologicals - January 17, 2019 Category: Biology Source Type: research
Control of therapeutic IgG antibodies galactosylation during cultivation process and its impact on IgG1/FcγR interaction and ADCC activity
Publication date: Available online 15 January 2019Source: BiologicalsAuthor(s): Vladimir Simonov, Sergey Ivanov, Maxim Smolov, Svetlana Abbasova, Aleksandr Piskunov, Dmitry PoteryaevAbstractTherapeutic 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 cu...
Source: Biologicals - January 15, 2019 Category: Biology Source Type: research
Establishment of the First National Reference Standard for Insulin Lispro: Report of a collaborative study
Publication date: Available online 11 January 2019Source: BiologicalsAuthor(s): 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, Participants of the StudyAbstractThe 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...
Source: Biologicals - January 12, 2019 Category: Biology Source Type: research
An ELISA using a recombinant chimera of protective antigen and lethal factor for serodiagnosis of cutaneous anthrax in India
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. The ELISA gave sensitivity of 100% (95% Confidence Interval [CI], 92.13 to 100) ...
Source: Biologicals - January 9, 2019 Category: Biology Source Type: research
Comparison of different PCR protocols and respective primer sets from pool of TAMS 1 gene for diagnosis of calf theileriosis from semi arid India
Publication date: Available online 12 December 2018Source: BiologicalsAuthor(s): Sanjhi Paliwal, Daya Shanker, Vikrant Sudan, Sanjeev Kumar, Mukesh Srivastava, Kapil Kumar GuptaAbstractThe 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 encod...
Source: Biologicals - December 13, 2018 Category: Biology Source Type: research
Interlaboratory comparison about feasibility of insoluble particulate matter test for injections with reduced test volume in light obscuration method
Publication date: Available online 13 December 2018Source: BiologicalsAuthor(s): Akira Harazono, Hiroko Shibata, Masato Kiyoshi, Takashi Muto, Jun Fukuda, Tetsuo Torisu, Satoshi Saitoh, Hirotaka Nishimura, Susumu Uchiyama, Akiko Ishii-WatabeAbstractInsoluble 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 v...
Source: Biologicals - December 13, 2018 Category: Biology Source Type: research
Evaluation of two WHO First International Standards for Vi polysaccharide from Citrobacter freundii and Salmonella enterica subspecies enterica serovar Typhi
Publication date: Available online 27 November 2018Source: BiologicalsAuthor(s): Fang Gao, Carolyn Swann, Peter Rigsby, Sjoerd Rijpkema, Kay Lockyer, Alastair Logan, Barbara Bolgiano, Thierry Pronce, Olivier Germay, Valérian Bunel, Wim Van Molle, Lorenzo Tesolin, Derek J. Hodgson, Yves Aubin, Richard Siggers, Bin Wang, Haoyu Liang, Ming Zeng, Ani Li, Yueping LiuAbstractNumerous 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 requireme...
Source: Biologicals - November 28, 2018 Category: Biology Source Type: research
