1,725 results match your criteria Biologicals [Journal]


Characterization of inflammatory bowel disease management by vedolizumab and concomitant treatments in real-life clinical practice.

Biologicals 2019 Feb 9. Epub 2019 Feb 9.

Department of Gastroenterology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.

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. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S10451056183033
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http://dx.doi.org/10.1016/j.biologicals.2019.01.007DOI Listing
February 2019
2 Reads

Demonstration of functional similarity of a biosimilar adalimumab SB5 to Humira.

Biologicals 2019 Feb 8. Epub 2019 Feb 8.

Bioanalysis Team, Samsung Bioepis Co., Ltd., 107, Cheomdan-daero, Yeonsu-gu, Incheon, 21987, Republic of Korea.

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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.12.002DOI Listing
February 2019

Performance characteristics of a fast real-time PCR assay for hepatitis B virus DNA quantification.

Biologicals 2019 Feb 1. Epub 2019 Feb 1.

Molecular Biology Department, Centro de InmunoEnsayo (CIE), Calle 134 y Avenida 25 Playa, Apartado Postal 6653, La Habana, CP 11600, Cuba.

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). Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.01.003DOI Listing
February 2019
2 Reads

In-depth site-specific O-Glycosylation analysis of therapeutic Fc-fusion protein by electron-transfer/higher-energy collisional dissociation mass spectrometry.

Biologicals 2019 Jan 28. Epub 2019 Jan 28.

Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa, 210-9501, Japan.

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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.01.005DOI Listing
January 2019

Virus removal robustness of ion exchange chromatography.

Biologicals 2019 Jan 17. Epub 2019 Jan 17.

AstraZeneca/MedImmune, R&D, Gaithersburg, MD, 20878, USA.

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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.01.004DOI Listing
January 2019
9 Reads

Use of hexon as an antigen for the production of monoclonal antibodies capable of detecting multiple adenovirus types.

Biologicals 2019 Jan 17. Epub 2019 Jan 17.

Smorodintsev Research Institute of Influenza, Russian Ministry of Health, 197376, prof. Popov St. 15/17, St. Petersburg, Russia.

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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.01.006DOI Listing
January 2019
2 Reads

Method for the determination of residual formaldehyde in an inactivated Zika vaccine formulated with aluminum hydroxide gel.

Biologicals 2019 Jan 16. Epub 2019 Jan 16.

Japan CMC, Product Operations, Global Vaccine Business Unit, Takeda Pharmaceutical Company Limited, 4720 Takeda, Mitsui, Hikari, Yamaguchi, 743-8502, Japan.

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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.12.001DOI Listing
January 2019
1 Read

Control of therapeutic IgG antibodies galactosylation during cultivation process and its impact on IgG1/FcγR interaction and ADCC activity.

Biologicals 2019 Jan 15. Epub 2019 Jan 15.

International Biotechnology Center "Generium" LLC, 14 Vladimirskaya Street, Volginsky, 601125, Russian Federation.

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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.01.002DOI Listing
January 2019
5 Reads
1.209 Impact Factor

Establishment of the First National Reference Standard for Insulin Lispro: Report of a collaborative study.

Biologicals 2019 Jan 10. Epub 2019 Jan 10.

National Institute of Biologicals, A-32, Sector-62, NOIDA 201309, India.

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. The candidate standard was calibrated against the Ph. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S10451056183006
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http://dx.doi.org/10.1016/j.biologicals.2018.10.004DOI Listing
January 2019
4 Reads

An ELISA using a recombinant chimera of protective antigen and lethal factor for serodiagnosis of cutaneous anthrax in India.

Biologicals 2019 Jan 8;57:55-60. Epub 2019 Jan 8.

Defence Research & Development Establishment, Jhansi Road, Gwalior, 474 002, India. Electronic address:

In this study, an ELISA was developed for simultaneous detection of antibodies against both the important toxins of B. anthracis i.e. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.01.001DOI Listing
January 2019
2 Reads
1.209 Impact Factor

Interlaboratory comparison about feasibility of insoluble particulate matter test for injections with reduced test volume in light obscuration method.

Biologicals 2019 Jan 13;57:46-49. Epub 2018 Dec 13.

Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Tonomachi 3-25-26, Kawasaki-ku, Kanagawa, 210-9501, Japan.

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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.12.003DOI Listing
January 2019
2 Reads

Comparison of different PCR protocols and respective primer sets from pool of TAMS 1 gene for diagnosis of calf theileriosis from semi arid India.

Biologicals 2019 Jan 12;57:50-54. Epub 2018 Dec 12.

U P Pandit Deen Dayal Upadhyaya Pashu Chikitsa Vigyan Vishwavidyalaya Evam Go Anusandhan Sansthan (DUVASU), Mathura, 281001, India.

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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.12.004DOI Listing
January 2019
3 Reads
1.209 Impact Factor

Evaluation of two WHO First International Standards for Vi polysaccharide from Citrobacter freundii and Salmonella enterica subspecies enterica serovar Typhi.

Biologicals 2019 Jan 27;57:34-45. Epub 2018 Nov 27.

Division of Bacteriology, National Institute for Biological Standards and Control, Blanche Lane, Potters Bar, Hertfordshire, EN6 3QG, UK.

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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.11.004DOI Listing
January 2019
3 Reads

The evaluation of an immunoperoxidase assay applicable in antiviral drug screening.

Biologicals 2019 Jan 23;57:61-66. Epub 2018 Nov 23.

Key Laboratory for Animal Immunology of the Ministry of Agriculture, Henan Provincial Key Laboratory of Animal Immunology, Henan Academy of Agricultural Sciences, Zhengzhou, Henan Province, 450002, China; Jiangsu Co-innovation Center for Prevention and Control of Important Animal Infectious Diseases and Zoonoses, College of Veterinary Medicine, Yangzhou University, Yangzhou, Jiangsu Province, 225009, China. Electronic address:

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). Read More

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https://linkinghub.elsevier.com/retrieve/pii/S10451056183021
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http://dx.doi.org/10.1016/j.biologicals.2018.10.006DOI Listing
January 2019
11 Reads
1.209 Impact Factor

Development and validation of a robust multiplex serological assay to quantify antibodies specific to pertussis antigens.

Biologicals 2019 Jan 18;57:9-20. Epub 2018 Nov 18.

Meningitis and Vaccine Preventable Diseases Branch, Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA.

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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.11.001DOI Listing
January 2019
17 Reads

Avian leukosis virus subgroup - J as a contaminant in live commercially available poultry vaccines distributed in Nigeria.

Biologicals 2019 Jan 16;57:29-33. Epub 2018 Nov 16.

National Veterinary Research Institute, PMB 01, Vom, Nigeria.

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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.11.003DOI Listing
January 2019
1 Read

Determination of residual poly diallyldimethylammonium chloride (pDADMAC) in monoclonal antibody formulations by size exclusion chromatography and evaporative light scattering detector.

Biologicals 2019 Jan 14;57:21-28. Epub 2018 Nov 14.

Biopharmaceutical Research Center, AryoGen Pharmed Inc., Alborz University of Medical Sciences, Karaj, Iran.

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. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S10451056183018
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http://dx.doi.org/10.1016/j.biologicals.2018.11.002DOI Listing
January 2019
11 Reads

Human single-chain variable fragment antibody expressed in E. coli with optimal in vitro cross-neutralizing and no enhancing activity.

Biologicals 2018 Nov 26;56:54-62. Epub 2018 Oct 26.

Center of Excellence for Antibody Research (CEAR), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Social and Environmental Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. Electronic address:

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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.10.003DOI Listing
November 2018
12 Reads

Differentiation of stem cells from the apical papilla into osteoblasts by the elastic modulus of porous silk fibroin scaffolds.

Biologicals 2019 Jan 2;57:1-8. Epub 2018 Nov 2.

Department of Biology, Faculty of Science, Arak University, Arak, Iran.

In addition to traditional approach for differentiation (biochemical factors), physical properties (elastic modulus) of the matrix will be becoming an important factor in differentiation of stem cells into different lineages. The porous scaffolds were prepared from the silk fibroin solutions 4%, 5%, 6%, 7% and 8.4% weight per volume (w/v) by freeze drying which produced scaffolds with the minimal changes in the pore size (96-160 μm) but with a ≈ 8-fold range of modulus (16 -131 kPa) in the wet condition. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S10451056183007
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http://dx.doi.org/10.1016/j.biologicals.2018.10.005DOI Listing
January 2019
9 Reads

Optimized upstream and downstream process conditions for the improved production of recombinant human asparaginase (rhASP) from Escherichia coli and its characterization.

Biologicals 2018 Nov 13;56:45-53. Epub 2018 Oct 13.

K L E F University, Centre for Bioprocess Technology, Department of Biotechnology, Guntur, 522 502, Andhra Pradesh, India. Electronic address:

The present work elucidates the production of recombinant human asparaginase (rhASP) under optimized fermentation and downstream processes in Escherichia coli. The maximum biomass yield of 6.7 g/L was achieved with fed-batch fermentation. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S10451056183018
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http://dx.doi.org/10.1016/j.biologicals.2018.10.002DOI Listing
November 2018
14 Reads

The combination of retinoic acid and estrogen can increase germ cells genes expression in mouse embryonic stem cells derived primordial germ cells.

Biologicals 2018 Nov 8;56:39-44. Epub 2018 Oct 8.

Gametogenesis Research Center, Kashan University of Medical Sciences, Kashan, Iran. Electronic address:

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 M of all-trans retinoic acid and the combination of 10 M of 17β-Estradiol and retinoic acid for 7, 12, 17 or 22 days. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S10451056183032
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http://dx.doi.org/10.1016/j.biologicals.2018.10.001DOI Listing
November 2018
2 Reads

Establishment of the first International Standard for human anti-typhoid capsular Vi polysaccharide IgG.

Biologicals 2018 Nov 7;56:29-38. Epub 2018 Sep 7.

Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom.

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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.09.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6238147PMC
November 2018
3 Reads

Immunization with Salmonella Abortusequi phage lysate protects guinea pig against the virulent challenge of SAE-742.

Biologicals 2018 Nov 1;56:24-28. Epub 2018 Sep 1.

Biological Standardization Division, Indian Veterinary Research Institute, Izatnagar, Bareilly, 243122, India.

Salmonella Abortusequi causes important clinical diseases in horses possibly leading to abortion. In the present investigation, the protective efficacy of both plain and aluminum hydroxide gel adjuvanted phage lysate was evaluated in guinea pig model. Broad host range bacteriophage P-SAE-2, was characterized and used for generation of lysates. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.08.006DOI Listing
November 2018
2 Reads

Influence of hydrodynamic pressure on chondrogenic differentiation of human bone marrow mesenchymal stem cells cultured in perfusion system.

Biologicals 2018 Nov 31;56:1-8. Epub 2018 Aug 31.

Stem Cell and Regenerative Medicine Group, National Institute of Genetic Engineering and Biotechnology, Tehran 14965/161, Iran. Electronic address:

The natural conditions of chondrocytes in native cartilage including mechanical forces and surface topology could be simulated to enhance chondrogenesis. A perfusion system recapitulating the hydrodynamic pressure of cartilage tissue is designed. Mesenchymal stem cells (MSCs) are isolated and seeded on aligned nanofibrous PCL/PLGA scaffolds that mimic the structure of superficial zone of articular cartilage. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.04.004DOI Listing
November 2018
6 Reads
1.210 Impact Factor

A risk assessment on extraneous virus contamination in a viral vaccine production environment justifies waiving of in vivo testing.

Biologicals 2018 Nov 31;56:9-12. Epub 2018 Aug 31.

Vaccine Quality Control, AJ Vaccines, 5 Artillerivej, DK2300, Copenhagen S, Denmark. Electronic address:

For many years in vivo assays have been a corner stone in safety testing of vaccines for human use. However, there is now an increasing regulatory focus on replacement, reduction and refinement of methods involving animal use. Accordingly, European Pharmacopoeia (Ph. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S10451056183024
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http://dx.doi.org/10.1016/j.biologicals.2018.07.005DOI Listing
November 2018
16 Reads

Preparation of F(ab') antivenom in Iraq against scorpion (Hottentotta saulcyi) venom.

Biologicals 2018 Nov 25;56:19-23. Epub 2018 Aug 25.

Department of Biomedical Sciences, College of Veterinary Medicine, University of Kirkuk, Kirkuk, Iraq.

The aim of this study was to prepare specific F(ab') antivenom against Iraqi scorpion (Hottentotta saulcyi). Venom was obtained by electrical stimulation method, the scorpions venom storage capacity was 1.7 ± 0. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.08.005DOI Listing
November 2018
253 Reads
1.210 Impact Factor

Report of the international conference on manufacturing and testing of pluripotent stem cells.

Biologicals 2018 Nov 24;56:67-83. Epub 2018 Aug 24.

National Institutes of Health (NIH), Emerita, USA.

Sessions included an overview of past cell therapy (CT) conferences sponsored by the International Alliance for Biological Standardization (IABS). The sessions highlighted challenges in the field of human pluripotent stem cells (hPSCs) and also addressed specific points on manufacturing, bioanalytics and comparability, tumorigenicity testing, storage, and shipping. Panel discussions complemented the presentations. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.08.004DOI Listing
November 2018
11 Reads

Calibration of the 7th British Working Standard for factors II, IX and X, concentrate.

Biologicals 2018 Nov 24;56:63-66. Epub 2018 Aug 24.

Haemostasis Section, Biotherapeutics Group, National Institute of Biological Standards and Control (NIBSC), South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK.

Seven laboratories from 5 different countries participated in the calibration of the 7th British Working Standard (BWS) for blood coagulation factors II, IX and X. The candidate, 15/182, was assayed for Factors II and X potencies against the 4th International Standard (IS) for Factors II and X, Concentrate (11/126) and for Factor IX potency against the 5th IS for Factor IX, Concentrate (14/148). Intra-laboratory GCVs for all 3 factors were less than 10%, with the majority less than 5%. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.08.007DOI Listing
November 2018
5 Reads

Re-evaluating the LD50 requirements in the codified potency testing of veterinary vaccines containing Leptospira (L.) serogroup Icterohaemorrhagiae and L. serogroup Canicola in the United States.

Biologicals 2018 Nov 17;56:13-18. Epub 2018 Aug 17.

Center for Veterinary Biologics, Animal and Plant Health Inspection Service, United States Department of Agriculture, P.O Box 844, Ames, IA, 50010, USA.

Approximately one-third of the reportable USDA Category D and E laboratory animals in the United States are expended on the potency testing of leptospiral vaccines by the codified hamster vaccination-challenge assay. Valid tests require ≥80% of challenge controls to succumb to disease and an LD50 between 10 and 10,000. This work evaluates the risk associated with the removal of LD50 limits; thereby, eliminating back-titration hamsters from in vivo potency assays for Leptospira (L. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S10451056183026
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http://dx.doi.org/10.1016/j.biologicals.2018.08.003DOI Listing
November 2018
8 Reads

Individual variability in humoral response of immunized outbred mice and cross-reactivity with prevalent Brazilian Neisseria meningitidis strains.

Biologicals 2018 Sep 10;55:19-26. Epub 2018 Aug 10.

Departamento de Imunologia do Instituto Adolfo Lutz, Av. Dr. Arnaldo 355, 11 Andar, 01246902, São Paulo, SP, Brazil; Programa de Pós-Graduação Interunidades em Biotecnologia, Instituto de Ciências Biomédicas, USP, São Paulo, SP, Brazil. Electronic address:

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http://dx.doi.org/10.1016/j.biologicals.2018.08.001DOI Listing
September 2018
2 Reads

Report of the international conference on next generation sequencing for adventitious virus detection in biologicals.

Biologicals 2018 Sep 6;55:1-16. Epub 2018 Aug 6.

Health Canada, Ottawa, Ontario, Canada.

A fundamental aspect of biological product safety is to assure absence of adventitious agents in the final product. Next-generation or high-throughput sequencing (NGS/HTS) has recently demonstrated detection of viruses that were previously missed using the recommended routine assays for adventitious agent testing of biological products. This meeting was co-organized by the International Alliance for Biological Standardization (IABS) and the U. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.08.002DOI Listing
September 2018
5 Reads

Proteome-wide identification of epitope-based vaccine candidates against multi-drug resistant Proteus mirabilis.

Biologicals 2018 Sep 2;55:27-37. Epub 2018 Aug 2.

Dr. Panjwani Center for Molecular Medicine and Drug Research, International Center for Chemical and Biological Sciences, University of Karachi, Karachi, 75270, Pakistan. Electronic address:

Proteus mirabilis is one of the important pathogens of urinary tract and exhibits resistance to multiple drugs. Development of vaccine tends to be the most promising and cost-effective remedy against the said pathogen. Herein, we implement a combinatorial approach for screening proteins harboring potential broad-spectrum antigenic epitopes in the proteome of P. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.07.004DOI Listing
September 2018
4 Reads

Evaluation of toll-like receptor 4 expression in human bone marrow mesenchymal stem cells by lipopolysaccharides from Shigella.

Biologicals 2018 Sep 2;55:53-58. Epub 2018 Jul 2.

Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran. Electronic address:

Lipopolysaccharides (LPS) from gram negative bacteria stimulate toll-like receptor 4 (TLR4) expression in immune cells. Recent reports state that bone marrow-derived cells such as mesenchymal stem cells (MSCs) also express TLR proteins. Numerous researches have studied the effect of a number of LPSs on TLR4 expression, but no data exists on the effect of LPSs from different strains of one bacterial genus on TLR4 expression. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.06.004DOI Listing
September 2018
11 Reads
1.210 Impact Factor

Baculovirus expression and purification of peste-des-petits-ruminants virus nucleocapsid protein and its application in diagnostic assay.

Biologicals 2018 Sep 17;55:38-42. Epub 2018 Jul 17.

ICAR-Indian Veterinary Research Institute, Hebbal, Bengaluru, 560 024, India.

Peste-des-petits-ruminants (PPR) is a contagious and highly devastating disease of small ruminants. For control of endemic PPR, adequate supply of affordable and reliable diagnostics is critical for effective surveillance, along with the use of highly efficacious live vaccines that are currently available. The nucleocapsid (N) protein of PPR virus (PPRV) is an important candidate antigen for developing specific diagnostic, as it is a major viral protein being highly immunogenic and conserved among the structural proteins. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.07.003DOI Listing
September 2018
4 Reads

Development of screening method for intranasal influenza vaccine and adjuvant safety in preclinical study.

Biologicals 2018 Sep 14;55:43-52. Epub 2018 Jul 14.

Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Gakuen 4-7-1, Musashimurayama, Tokyo, 208-0011, Japan. Electronic address:

Recently, many vaccine adjuvants have been developed; however, most of the newly developed adjuvants have been dropped out of preclinical and clinical trials owing to their unexpected toxicity. Thus, the development of highly quantitative and comparable screening methods for evaluating adjuvant safety is needed. In a previous study, we identified specific biomarkers for evaluating the safety of an intranasal influenza vaccine with CpG K3 adjuvant by comparing biomarker expression. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S10451056183021
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http://dx.doi.org/10.1016/j.biologicals.2018.07.001DOI Listing
September 2018
6 Reads
1.210 Impact Factor

Successful slow tocilizumab desensitization in a patient with adult onset Still disease.

Biologicals 2018 Sep 14;55:17-18. Epub 2018 Jul 14.

Eskisehir Osmangazi University, Medical Faculty, Department of Internal Medicine, Division of Rheumatology, Turkey.

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http://dx.doi.org/10.1016/j.biologicals.2018.07.002DOI Listing
September 2018
5 Reads

Development of a relative potency test using ELISA for human rabies vaccines.

Biologicals 2018 Sep 30;55:59-62. Epub 2018 Jun 30.

Wuhan Institute of Biological Products Co. Ltd, Wuhan, 430207, China. Electronic address:

The NIH potency test for human rabies vaccines has disadvantages for use, especially in developing countries where rabies is endemic and prophylaxis needs ample, rapid, and reliable vaccine supplies. In China, 60-75 million doses of human rabies vaccines are administered each year. Vaccine quality control is of paramount importance, as is the release of potency-validated vaccines. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S10451056183020
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http://dx.doi.org/10.1016/j.biologicals.2018.06.003DOI Listing
September 2018
9 Reads

WITHDRAWN: Establishment of the first International Standard for human anti-typhoid capsular Vi polysaccharide IgG.

Biologicals 2018 Jun 23. Epub 2018 Jun 23.

Center for Vaccine Development, University of Maryland Baltimore, 685 West Baltimore Street, Room 480, Baltimore, MD, USA.

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http://dx.doi.org/10.1016/j.biologicals.2018.05.007DOI Listing
June 2018
7 Reads

Detection of bovine viral diarrhoea virus nucleic acid, but not infectious virus, in bovine serum used for human vaccine manufacture.

Biologicals 2018 Sep 23;55:63-70. Epub 2018 Jun 23.

Department of Essential Medicines and Health Products, World Health Organization, Avenue Appia 22, Geneva, Switzerland.

Bovine viral diarrhoea virus (BVDV) is a cattle pathogen that has previously been reported to be present in bovine raw materials used in the manufacture of biological products for human use. Seven lots of trivalent measles, mumps and rubella (MMR) vaccine and 1 lot of measles vaccine from the same manufacturer, together with 17 lots of foetal bovine serum (FBS) from different vendors, 4 lots of horse serum, 2 lots of bovine trypsin and 5 lots of porcine trypsin were analysed for BVDV using recently developed techniques, including PCR assays for BVDV detection, a qRT-PCR and immunofluorescence-based virus replication assays, and deep sequencing to identify and genotype BVDV genomes. All FBS lots and one lot of bovine-derived trypsin were PCR-positive for the presence of BVDV genome; in contrast all vaccine lots and the other samples were negative. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.06.002DOI Listing
September 2018
7 Reads

First evaluation of endotoxins in veterinary autogenous vaccines produced in Italy by LAL assay.

Biologicals 2018 Sep 21;55:71-73. Epub 2018 Jun 21.

Istituto Zooprofilattico Sperimentale dell'Umbria e delle Marche "Togo Rosati" Pharmaceutical Unit, Via G. Salvemini 1, 06126, Perugia (PG), Italy.

Endotoxin contamination is a serious concern for manufacturers of biological products and vaccines in terms of not only quality but also safety parameters. We evaluated the endotoxin presence in different veterinary autogenous vaccines produced by the Pharmaceutical Unit at the Experimental Zooprophylactic Institute of Umbria and Marche "Togo Rosati" (IZSUM). According to the 3Rs principles (Replace, Reduce, Refine), which aim to progressively reduce animal use in the quality control process, we tested the vaccines obtained from gram-negative bacteria and adjuvants by the limulus amebocyte lysate (LAL) assay. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.06.001DOI Listing
September 2018
6 Reads

Comparative effectiveness of three-dimensional scaffold, differentiation media and co-culture with native cardiomyocytes to trigger in vitro cardiogenic differentiation of menstrual blood and bone marrow stem cells.

Biologicals 2018 Jul 6;54:13-21. Epub 2018 Jun 6.

Nanobiotechnology Research Center, Avicenna Research Institute, ACECR, Tehran, Iran. Electronic address:

The main purpose of this study was to find effectiveness of 3D silk fibroin scaffold in comparison with co-culturing in presence of native cardiomyocytes on cardiac differentiation propensity of menstural blood(MenSCs)-versus bone marrow-derived stem-cells (BMSCs). We showed that both 3D fibroin scaffold and co-culture system supported efficient cardiomyogenic differentiation of MenSCs and BMSCs, as judged by the expression of cardiac-specific genes and proteins, Connexin-43, Connexin-40, alpha Actinin (ACTN-2), Tropomyosin1 (TPM1) and Cardiac Troponin T (TNNT2). No significant difference (except for higher expression of ACTN-2 in co-cultured MenSCs) was found between differentiation potential of the cells cultured in 3D fibroin scaffold and co-culture system. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.05.003DOI Listing
July 2018
41 Reads
1.209 Impact Factor

Electrospun composite PLLA/Oyster shell scaffold enhances proliferation and osteogenic differentiation of stem cells.

Biologicals 2018 Jul 2;54:33-38. Epub 2018 Jun 2.

Stem Cell Technology Research Center, Tehran, Iran.

In bone tissue engineering, bioceramics are of the most widely used materials for treatment of bone defects clinically. The composites of bioceramic/polymer fibrous scaffolds have been designed and developed to fulfill the mechanical and biological requirements of the damaged tissue. In the present study, oyster shell (OS) as a bioceramic in combination with the biodegradable and biocompatible poly (l-lactide) has been used to prepare a new tissue-engineered composite. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.04.006DOI Listing
July 2018
30 Reads

Host cell protein testing strategy for hepatitis B antigen in Hexavalent vaccine - Towards a general testing strategy for recombinant vaccines.

Biologicals 2018 Jul 31;54:1-7. Epub 2018 May 31.

Sanofi Pasteur, 1541 Avenue Marcel Merieux, 69280 Marcy L'Etoile, France.

Background: Recombinant proteins expressed in host cell systems may contain host cell proteins (HCP) as impurities. While there is no clear evidence of clinical adverse events attributable to HCP, HCP levels and profiles must be documented to meet regulatory requirements and to understand the consistency of the biological product and manufacturing process. We present a general strategy for HCP characterization applied to a recombinant protein antigen, Hepatitis B surface antigen (HBsAg) used in a multivalent vaccine. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.05.006DOI Listing
July 2018
7 Reads

Development of an anti-EPO antibody detection kit based on lab-on-a-chip and bridging antibody technologies.

Biologicals 2018 Jul 17;54:8-12. Epub 2018 May 17.

Department of Pharmacy, Integrated Research Institute of Pharmaceutical Sciences, and BK21 PLUS Team for Creative Leader Program for Pharmacomics-based Future Pharmacy, College of Pharmacy, The Catholic University of Korea, 43 Jibong-ro, Wonmi-gu, Bucheon-si, Gyeonggi-do, 14662, Republic of Korea; ILAb Inc., NP513, College of Pharmacy, The Catholic University of Korea, Bucheon, 420-743, Republic of Korea. Electronic address:

Immunogenicity is a major concern in the use of biological drugs. In particular, antibody-mediated pure red cell aplasia (PRCA) is a rare condition that is caused by administration of recombinant erythropoietin. There are numerous assay platforms for detect EPO anti-drug antibody (ADA), and most have appropriate assay sensitivity, but in need of improvement in terms of assay turnaround time and user accessibility. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.05.005DOI Listing
July 2018
15 Reads

Coculture of conjunctiva derived mesenchymal stem cells (CJMSCs) and corneal epithelial cells to reconstruct the corneal epithelium.

Biologicals 2018 Jul;54:39-43

Laboratory for Stem Cell & Regenerative Medicine, Natural and Medical Sciences Research Center, University of Nizwa, Nizwa, P. O. Box: 33, PC 616, Oman.

Coculture systems are widely used in tissue engineering to mimic cell-cell interactions between different populations. This study aimed to find an improved and convenient system for the corneal epithelial differentiation of conjunctiva derived mesenchymal stem cells (CJMSCs). Thus, the cells were used to reconstruct corneal epithelial cells. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.04.005DOI Listing
July 2018
8 Reads

Distribution and absence of generalized lesions in mice following single dose intramuscular inoculation of the vaccine candidate MVA-MERS-S.

Biologicals 2018 Jul;54:58-62

Institute for Infectious Diseases and Zoonoses, LMU Munich, Germany; German Center for Infection Research (DZIF), Munich Partner Site, Germany.

Modified Vaccinia Virus Ankara (MVA) is a highly attenuated and replication-deficient virus serving as vaccine against infectious diseases. Here, we assessed the in vivo distribution of a recombinant MVA candidate vaccine against the Middle Eastern Respiratory Syndrome (MVA-MERS-S) in mice. Intramuscularly inoculated mice were necropsied at different time points and examined by histology, immunohistochemistry and real-time PCR. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.05.004DOI Listing
July 2018
3 Reads

Adherence to biologic therapy - Does it vary with ethnicity?

Biologicals 2018 Jul 9;54:28-32. Epub 2018 May 9.

Rheumatology Department, Luton & Dunstable University Hospital NHSFT, Luton, UK.

BackgroundPoor adherence to therapy remains a significant barrier to improving clinical outcomes in rheumatic diseases and carries a major financial burden. It has been linked to medication related patient beliefs, which were reported to differ between ethnic groups. Little is known about these variations in biologic therapies cohorts. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.05.001DOI Listing
July 2018
7 Reads

Development of a highly sensitive PCR/DNA chip method to detect mycoplasmas in a veterinary modified live vaccine.

Biologicals 2018 Jul 10;54:22-27. Epub 2018 May 10.

Merial, Lyon Gerland 254 rue Marcel Mérieux, 69007 Lyon, France(1).

Mycoplasmas are potential contaminants that introduce undesirable changes in mammalian cell cultures. They frequently contaminate cell substrates and other starting materials used for manufacturing cell-derived biologics, such as vaccines and pharmaceutical products. Mycoplasma purity testing of live vaccines, active ingredients, raw material, and seed lots is required during vaccine production. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.05.002DOI Listing
July 2018
14 Reads

Immortalization of chicken embryonic liver-derived cell line by stable expression of hMRP18S-2 for serotype 4 fowl adenovirus propagation.

Biologicals 2018 Jul 8;54:50-57. Epub 2018 May 8.

Institute of Animal Immune Engineering, Jiangsu Academy of Agricultural Sciences, Nanjing, China; National Research Center of Engineering and Technology for Veterinary Biologicals, Jiangsu Academy of Agricultural Sciences, Nanjing, China; Jiangsu Co-innovation Center for Prevention and Control of Important Animal Infectious Diseases and Zoonoses, Yangzhou, China.

Inclusion body hepatitis and hydropericardium-hepatitis syndrome caused by serotype 4 fowl adenovirus (FAdV-4) have emerged in China since 2013. FAdV is usually propagated in primary chicken embryonic liver cells or embryo yolk sac. The aim of this work was to develop an immortalized CEL cell line by stable expression of human mitochondrial ribosomal protein 18S-2, named CEL-hMRP18S-2 cells, for the propagation of FAdV-4. Read More

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http://dx.doi.org/10.1016/j.biologicals.2018.04.002DOI Listing
July 2018
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Drug survival of biologic therapies for the treatment of psoriasis: Results of Slovenian national registry.

Biologicals 2018 Jul 26;54:44-49. Epub 2018 Apr 26.

Department of Dermatovenereology, University Medical Centre Ljubljana, Zaloska cesta 2, 1000 Ljubljana, Slovenia; Medical Faculty, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia.

The study was designed as observational retrospective analysis of the data from Slovenian Registry of patients with moderate and severe psoriasis treated with adalimumab, etanercept, infliximab or ustekinumab from 2005 to 2015. The survival rates of biologics were compared using survival analysis, and predictors of discontinuation were evaluated using a Cox regression model. All biologics have been prescribed as a first line therapy for moderate or severe psoriasis; 650 (94. Read More

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https://linkinghub.elsevier.com/retrieve/pii/S10451056183009
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http://dx.doi.org/10.1016/j.biologicals.2018.04.003DOI Listing
July 2018
7 Reads