Isolation and characterization of phage (ETP-1) specific to multidrug resistant pathogenic Edwardsiella tarda and its in vivo biocontrol efficacy in zebrafish (Danio rerio)
Publication date: Available online 27 December 2019Source: BiologicalsAuthor(s): Chamilani Nikapitiya, H.P.S.U. Chandrarathna, S.H.S. Dananjaya, Mahanama De Zoysa, Jehee LeeAbstractEdwardsiella tarda phage (ETP-1) was isolated from marine fish farm water to characterize its effect against pathogenic multidrug-resistant E. tarda. According to transmission electron microscopy results, ETP-1 is classified as a member of the family Podoviridae. ETP-1 showed MOI dependent E. tarda growth inhibition, a latent period of 60 min, and burst size of 100 PFU per infected cells. In host range tests, five out of eight E. tarda strains...
Source: Biologicals - December 28, 2019 Category: Biology Source Type: research
Development of anti-drug monoclonal antibody panels against adalimumab and infliximab
Publication date: Available online 27 December 2019Source: BiologicalsAuthor(s): Takuo Suzuki, Minoru Tada, Akiko Ishii-WatabeAbstractThe generation of anti-drug antibodies (ADAs) is one of the most serious problems in therapy using monoclonal antibodies (mAbs), because ADAs can impact the pharmacokinetics, efficacy, and safety of mAbs. It is therefore important to detect the generated ADAs in patients. For the appropriate detection of ADAs, methods that detect various types of ADAs (e.g., low- and high-affinity ADAs) are needed, but since there are no adequate reference preparations of ADAs relevant to human ADAs in most ...
Source: Biologicals - December 27, 2019 Category: Biology Source Type: research
Overexpression of microRNA-375 and microRNA-122 promotes the differentiation of human induced pluripotent stem cells into hepatocyte-like cells
In this study, we evaluated the use of overexpression of microRNA-375 (miR-375) and miR-122 in differentiating the Human Induced Pluripotent Stem Cells (hiPSCs) into functional hepatocyte-like cells (HLCs) without growth factors. We also compared the differentiation by miRNAs versus growth factors. HiPSCs were divided into two main groups: 1- HiPSCs were induced using lentiviral overexpression of miR-375 to differentiate into definitive endoderm (DE) cells in seven days. Then lentiviral overexpression of miR-122 was applied to differentiate DE cells into HLCs in additional 14 days. 2- HiPSCs were differentiated into HLCs u...
Source: Biologicals - December 26, 2019 Category: Biology Source Type: research
The first World Health Organization International Standard for in vitro biological activity of darbepoetin
Publication date: Available online 18 December 2019Source: BiologicalsAuthor(s): Ben Cowper, Jason Hockley, Katherine Partridge, Jackie Ferguson, Peter Rigsby, Chris BurnsAbstractThe expiry of patents protecting the manufacture and sale of therapeutic darbepoetin products is expected to lead to the emergence of biosimilar products. In response to this, the first World Health Organization (WHO) International Standard (IS) for darbepoetin has been developed. A lyophilized preparation of darbepoetin, coded 17/204, was evaluated in an international collaborative study, the results of which suggest that the candidate preparatio...
Source: Biologicals - December 18, 2019 Category: Biology Source Type: research
Quality by Design approaches to assessing the robustness of tangential flow filtration for MAb
This article illustrates a case study of TFF robustness performed for a process characterization of a monoclonal antibody under QbD principles by exploring functional relationships that link the process parameters to quality/process attributes with prior process knowledge, risk assessment, and multivariate experiments. In every case of quality or process attributes, all measured values were in alignment with the allowable specification range, and the developed models were non-significant and had no lack of fit, thus confirming the robustness of the TFF process within the tested ranges of process parameters. (Source: Biologicals)
Source: Biologicals - December 15, 2019 Category: Biology Source Type: research
Brucella abortus S19 rfbD mutant is highly attenuated, DIVA enable and confers protection against virulent challenge in mice
In this study, rfbD gene deleted mutant S19 was developed. The mutant strain designated S19ΔR displayed rough LPS phenotype, which was confirmed by acriflavine dye-agglutination and LPS-SDS-PAGE analysis. The virulence was amply reduced as suggested by increased sensitivity to complement killing; reduction in splenic-bacterial load and the recovery time RT50 as validated in mice model. Anti-brucella humoral response was significantly lower as compared to S19 immunization. The minimal induction of Brucella specific IgG1, IgG2a & IgG2b, and IgG3 resulted in no apparent reactivity to RBPT antigen. S19ΔR showed protective in...
Source: Biologicals - December 14, 2019 Category: Biology Source Type: research
Potent virucidal activity against Flaviviridae of a group IIA phospholipase A2 isolated from the venom of Bothrops asper
Publication date: Available online 12 December 2019Source: BiologicalsAuthor(s): Hebleen Brenes, Gilbert D. Loría, Bruno LomonteAbstractSecreted phospholipase A2 (sPLA2) molecules are small, calcium-dependent enzymes involved in many biological processes. Viperid venoms possess gIIA sPLA2s and sPLA2-like proteins, both having homology to human gIIA sPLA2, an innate immunity enzyme. We evaluated the antiviral action of Mt–I (catalytically-active sPLA2) and Mt-II (catalytically-inactive variant) isolated from the venom of Bothrops asper, against a diverse group of viruses. Yellow Fever and Dengue (enveloped) viruses were ...
Source: Biologicals - December 13, 2019 Category: Biology Source Type: research
Pragmatic rules for comparability of biological medicinal products
Publication date: Available online 11 December 2019Source: BiologicalsAuthor(s): R. Martijn van der Plas, Marcel H.N. Hoefnagel, Hans L. Hillege, Kit C.B. RoesAbstractComparability is a key concept in the evaluation of both manufacturing changes and biosimilars. It constitutes a pragmatic and flexible approach which recognises that biologicals are inherently variable and that minor variations in quality attributes are often clinically irrelevant. In this discussion paper, we argue that comparability exercises rely on a number of pragmatic criteria. These criteria have been remarkably robust for 20 years of comparability ex...
Source: Biologicals - December 11, 2019 Category: Biology Source Type: research
Corrigendum to “Generation of acid resistant virus like particles of vaccine strains of foot-and-mouth disease virus (FMDV)” [Biologicals 60 (2019) 28–35]
Publication date: Available online 22 November 2019Source: BiologicalsAuthor(s): D.P.R. Selvaraj, P. Saravanan, J.K. Biswal, S.H. Basagoudanavar, H.J. Dechamma, V. Umapathi, B.P. Sreenivasa, R.P. Tamilselvan, N. Krishnaswamy, I. Zaffer, A. Sanyal (Source: Biologicals)
Source: Biologicals - November 23, 2019 Category: Biology Source Type: research
A class Ⅰ lentogenic newcastle disease virus strain confers effective protection against the prevalent strains
In this study, an NDV isolate APMV-1/Chicken/China (SC)/PT3/2016 (hereafter referred as PT3) was identified as a class Ⅰ NDV and a lentogenic strain. The antigenic relationship between PT3 and 3 other NDV strains, including vaccine strain LaSota and 2 prevalent genotype Ⅶd and Ⅵb strains were analyzed. The protective efficacy of PT3 and LaSota against challenge with genotype Ⅶd and Ⅵb strains were assessed. The antigenic analysis result showed that 4 strains belong to the single serotype and the PT3 antiserum exhibited the highest HI titer against 3 other NDV strains. The results of protective efficacy showed tha...
Source: Biologicals - November 19, 2019 Category: Biology Source Type: research
Aims and Scope/Editorial Board/Publishing Details
Publication date: November 2019Source: Biologicals, Volume 62Author(s): (Source: Biologicals)
Source: Biologicals - November 10, 2019 Category: Biology Source Type: research
Pentaplex PCR assay for rapid differential detection of Babesia bigemina, Theileria annulata, Anaplasma marginale and Trypanosoma evansi in cattle
Publication date: Available online 7 November 2019Source: BiologicalsAuthor(s): Anita Ganguly, Biswa Ranjan Maharana, Indrajit GangulyAbstractA multiplex PCR (mPCR) assay for simultaneous detection and differentiation of four major haemoparasites in crossbred cattle was established using parasite specific genomic DNA and four sets of primer pairs targeting AMA-1, Tams1, MSP5 and VSG genes of Babesia bigemina, Theileria annulata, Anaplasma marginale and Trypanosoma evansi generating precise amplicons of 448, 156, 382 and 110 bp, respectively. An internal amplification control, 202 bp bovine β-casein gene fragment, was simu...
Source: Biologicals - November 8, 2019 Category: Biology Source Type: research
Global harmonization of vaccine testing requirements: Making elimination of the ATT and TABST a concrete global achievement
This report expounds the outcomes of the symposium, and introduces a proposed roadmap – populated with country specific activities – for the elimination of these tests. (Source: Biologicals)
Source: Biologicals - November 6, 2019 Category: Biology Source Type: research
Isolation and characterization of bacteriophage to control multidrug-resistant Pseudomonas aeruginosa planktonic cells and biofilm
Publication date: Available online 2 November 2019Source: BiologicalsAuthor(s): Muhammad Adnan, Muhammad Rahman Ali Shah, Muhsin Jamal, Fazal Jalil, Saadia Andleeb, Muhammad Asif Nawaz, Sidra Pervez, Tahir Hussain, Ismail Shah, Muhammad Imran, Atif KamilAbstractPseudomonas aeruginosa is Gram-negative bacterium, one of the leading cause of drug-resistant nosocomial infections in developing countries. This bacterium possesses chromosomally encoded efflux pumps, poor permeability of outer-membrane and high tendency for biofilm formation which are tools to confer resistance. Bacteriophages are regarded as feasible treatment op...
Source: Biologicals - November 3, 2019 Category: Biology Source Type: research
Efficacy and safety of original and biosimilar etanercept (SB4) in active rheumatoid arthritis – A comparison in a real-world national cohort
ConclusionBiosimilar and original etanercept showed similar efficacy and safety after the first 6 months of treatment in RA patients from a national registry, which brings further evidence for biosimilarity in unselected patients in real-world setting. (Source: Biologicals)
Source: Biologicals - October 25, 2019 Category: Biology Source Type: research
