1,820 results match your criteria Biologicals[Journal]


Potency evaluation of rabies vaccine for human use: The impact of reducing the number of animals per dilution - Part 2.

Biologicals 2020 May 22. Epub 2020 May 22.

Instituto Nacional de Controle de Qualidade em Saúde (INCQS) - FIOCRUZ, Av. Brasil, 4365, Manguinhos, Rio de Janeiro, RJ, ZIP: 21040-900, Brazil. Electronic address:

The most critical parameter for the quality control of the rabies vaccine is potency, which is evaluated by challenge test in mice while using a large animal number. Because the 3Rs concept is applied worldwide, it becomes necessary to develop alternative methods to demonstrate the production consistency of these vaccines and reduce the number of animals used for performing assays. Hence, the present study evaluated the impacts of reducing the number of mice used in the NIH test for such vaccines. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.05.001DOI Listing

Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019.

Biologicals 2020 May 4. Epub 2020 May 4.

Nigerian National Agency for Food and Drug Administration and Control (NAFDAC), African Vaccine Regulatory Forum (AVAREF), Nigeria.

Controlled human infection models can be helpful to study pathogenesis and immune responses as a basis for the development of vaccines. In controlled human infection models, human challenge agents are used to infect healthy volunteers, therefore, ethical considerations include that the exposure studies need to be safe and results should be meaningful, e.g. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.04.005DOI Listing

Another case of mistaken identity? Vaccinia virus in another live Camelpox vaccine.

Biologicals 2020 May 22;65:39-41. Epub 2020 Apr 22.

Department of Biosciences, College of Science, Swansea University, Swansea, United Kingdom.

Camelpox virus is the causative agent of Camelpox, a highly contagious disease of camels. A high passage Camelpox virus strain has previously been reported to contain several genes which more closely resemble Vaccinia, a virus species with no known natural host, encompassing various strains that show high inter-strain genomic variation. In this study, we demonstrate that yet another high passage, live attenuated vaccine, comprising a different strain of Camelpox virus, contains genomic sequences that match a differing strain of Vaccinia virus. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.04.002DOI Listing

New paths for sustainable solutions to tackle global and emerging infectious threats.

Authors:
Anja Holm

Biologicals 2020 May 20;65:42-45. Epub 2020 Apr 20.

Central VetPharma Consultancy Aps, Hauchsvej 7, 4180, Soroe, Denmark. Electronic address:

With the dramatic background of a newly emerged virus (SARS-CoV-2) spreading around the world, Coronavirus and other infectious health threats for the human and animal populations were illustrated and debated in excellent presentations at the IABS meeting 26-28 of February 2020. Historical evidence of pandemics and lessons learned from recent epidemics or epizootics caused by many pathogens (e.g. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.04.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7167553PMC

An investigation into gene copy number determination in transgenic yeast; The importance of selecting a reliable real-time PCR standard.

Biologicals 2020 May 8;65:10-17. Epub 2020 Apr 8.

Department of Quality Control, Research and Production Complex, Pasteur Institute of Iran, Tehran, Iran. Electronic address:

Nowadays, Pichia pastoris is a well-known yeast for the production of recombinant proteins. The yield of protein production tightly depends on the copy number of the gene of interest into the host chromosome. Real-time PCR has been used as a high throughput method for molecular detection of gene copy number. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.04.001DOI Listing

The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019.

Biologicals 2020 May 27;65:1-9. Epub 2020 Mar 27.

World Health Organization, Department of Health Products Policy and Standards, Avenue Appia 20, CH-1211, Geneva, Switzerland.

The World Health Assembly in 2014 adopted a resolution that mandates both Member States and the WHO Secretariat to facilitate access to biotherapeutic products in a way that ensures their quality, safety and efficacy. The availability of biosimilars is expected to increase access to biotherapeutic products by providing more treatment options triggering competition which would lead to a consistent reduction in the average price of treatment. Since the WHO guidelines for regulatory evaluation of biosimilars were issued in 2009, WHO has provided immense effort towards harmonizing the terminology and the regulatory framework for biosimilars globally. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.02.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7254057PMC

High-Throughput Sequencing (HTS) of newly synthetized RNAs enables one shot detection and identification of live mycoplasmas and differentiation from inert nucleic acids.

Biologicals 2020 May 26;65:18-24. Epub 2020 Mar 26.

PathoQuest, Paris, France; Ecole Nationale Vétérinaire d'Alfort, Université Paris-Est, Maisons-Alfort, 94704 Cedex, France; Pathogen Discovery Laboratory, Institut Pasteur, Paris, France. Electronic address:

Mycoplasma contamination threatens both the safety of biologics produced in cell substrates as well as the quality of scientific results based on cell-culture observations. Methods currently used to detect contamination of cells include culture, enzymatic activity, immunofluorescence and PCR but suffer from some limitations. High throughput sequencing (HTS) can be used to identify microbes like mycoplasmas in biologics since it enables an unbiased approach to detection without the need to design specific primers to pre-amplify target sequences but it does not enable the confirmation of microbial infection since this could reflect carryover of inert sequences. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.03.002DOI Listing

Obstacles to vaccination of animals and prospective solutions.

Biologicals 2020 May 21;65:46-49. Epub 2020 Mar 21.

Department of Virology, Wageningen Bioveterinary Research, P.O. Box 65, 8200 AB, Lelystad, the Netherlands; Laboratory of Virology, Wageningen University, Droevendaalsesteeg 1, 6708 PB, Wageningen, the Netherlands. Electronic address:

On the 17th of October 2019, a workshop was held at Wageningen Bioveterinary Research in Lelystad, the Netherlands, to discuss the obstacles to vaccination in the veterinary field. Participants from academia, OIE, FAO, EC, EMA, USDA, national regulatory and veterinary health authorities, and the animal health industry discussed how availability and access to animal vaccines can be improved not just in the EU and US but also in Low to Middle Income Countries (LMIC) across the world and agreed that this requires innovations in both the scientific and the regulatory field. The workshop called for engaging all stakeholders to improve regulatory acceptance of novel vaccine technologies and encourage their registration. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.03.001DOI Listing

Content of anti-β-amyloid oligomers antibodies in multiple batches from different immunoglobulin preparations.

Biologicals 2020 May 9;65:25-32. Epub 2020 Mar 9.

Institute of Blood Transfusion, Chinese Academy of Medical Sciences& Peking Union Medical College, 26 Huacai Road, Chenghua District, Chengdu, 610052, China. Electronic address:

Immunoglobulin preparations are one of the promising drugs for Alzheimer's disease (AD). Anti-β-amyloid (Aβ) oligomers antibodies in immunoglobulin preparations are considered to be critical for the therapeutic effect against Alzheimer's disease. However, the antibodies content in immunoglobulin preparations varies greatly. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.02.004DOI Listing

A reliable assay for ensuring the biological activity of anti T lymphocyte immunoglobulin as an alternate to compendial flow cytometry method.

Biologicals 2020 May 6;65:33-38. Epub 2020 Mar 6.

National Institute of Biologicals, Ministry of Health and Family Welfare, Govt. of India, Sector 62, NOIDA, Uttar Pradesh, India. Electronic address:

The assay of Anti T lymphocyte immunoglobulin for final drug product testing is carried out using flow cytometry on Peripheral Blood Mononuclear Cells (PBMCs) as specified in European and British Pharmacopeia. An alternate assay was developed wherein the potency based quality control evaluation of Anti T lymphocyte immunoglobulin is carried out by measuring complement dependent cytotoxicity (CDC) using fluorescent resazurin dye. The reported bioassay was specific, linear (R = 0. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.01.002DOI Listing
May 2020
1.209 Impact Factor

Report of the 2019 NIST-FDA workshop on standards for next generation sequencing detection of viral adventitious agents in biologics and biomanufacturing.

Biologicals 2020 Mar 22;64:76-82. Epub 2020 Feb 22.

Center for Biologics Research and Evaluation, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. Electronic address:

Adventitious virus testing assures product safety by demonstrating the absence of viruses that could be unintentionally introduced during the manufacturing process. The capabilities of next-generation sequencing (NGS) for broad virus detection in biologics have been demonstrated by the detection of known and novel viruses that were previously missed using the recommended routine assays for adventitious agent testing. A meeting was co-organized by the National Institute of Standards and Technology and the U. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.02.003DOI Listing
March 2020
1.209 Impact Factor

Towards rabies elimination in the Asia-Pacific region: From theory to practice.

Biologicals 2020 Mar 20;64:83-95. Epub 2020 Feb 20.

Friedrich-Loeffler-Institut, Insel Riems, Germany.

Rabies is a major neglected zoonotic disease and causes a substantial burden in the Asian region. Currently, Pacific Oceania is free of rabies but enzootic areas throughout southeast Asia represent a major risk of disease introduction to this region. On September 25-26, 2019, researchers, government officials and related stakeholders met at an IABS conference in Bangkok, Thailand to engage on the topic of human rabies mediated by dogs. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.01.008DOI Listing

Immune globulin subcutaneous, human 20% solution (Xembify®), a new high concentration immunoglobulin product for subcutaneous administration.

Biologicals 2020 Mar 19;64:34-40. Epub 2020 Feb 19.

Grifols Bioscience Research Group, 85 TW Alexander Drive, Research Triangle Park, NC, 27709, USA.

Immune globulin subcutaneous, human 20% solution (IGSC-C 20%, Xembify®)-a new 20% immunoglobulin (IgG) liquid product for subcutaneous (SC) administration-has been developed by Grifols. The IGSC-C 20% formulation is based on knowledge acquired from the formulation of Immune Globulin Injection (Human),10% Caprylate/Chromatography Purified (IGIV-C 10%, Gamunex®-C). The protein concentration was increased from 10% to 20% to provide a smaller volume for SC administration. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.01.004DOI Listing

A next-generation sequencing based method for determining genetic stability in Clostridium tetani vaccine strains.

Biologicals 2020 Mar 11;64:10-14. Epub 2020 Feb 11.

Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.

Production of tetanus and other clostridial vaccines highly depends on the stable and reproducible production of high toxin levels. This creates a need to ensure the genetic stability of seed strains. We developed a two-stage method for improved assessment of the genetic stability of Clostridium seed strains. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.02.001DOI Listing

Virus disinfection for biotechnology applications: Different effectiveness on surface versus in suspension.

Biologicals 2020 Mar 11;64:1-9. Epub 2020 Feb 11.

Global Pathogen Safety, Baxter AG, Benatzkygasse 2-6, 1221, Vienna, Austria(1). Electronic address:

Virus contamination events in cell culture-based biotechnology processes have occurred and have had a dramatic impact on the supply of life-saving drugs, and thus on the wellbeing of patients. Cleanup requires effective and robust virucidal decontamination procedures for both the liquid reactor content before discharge, as well as facility surfaces to prevent recurrence. Beyond rare contamination events, it is important to implement virucidal disinfection for change-over procedures as effective preventive measure in routine biomanufacturing. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.02.002DOI Listing

Purification and in vivo stability and half-life of recombinant lipid modified staphylokinase.

Biologicals 2020 Mar 6;64:15-22. Epub 2020 Feb 6.

Department of Science and Technology, Ministry of Science and Technology, Govt. of India, Technology Bavan, New Mehrauli Road, New Delhi, 110016, India. Electronic address:

Staphylokinase (SAK), the thrombolytic protein holds a significant position in treating cardiovascular diseases. However, the rapid clearance of this protein from blood circulation reduces its effective usage and as a strategy to increase the half-life of SAK, initial work focussed on lipid modification of SAK (LMSAK) in E. coli GJ1158. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.01.009DOI Listing

Establishment of the national reference standard for tetanus toxoid in Thailand.

Biologicals 2020 Mar 23;64:73-75. Epub 2020 Jan 23.

Institute of Biological Products, Department of Medical Sciences, Ministry of Public Health, 88/7 Tiwanon Rd., Amphoe Muang, Nonthaburi, 11000, Thailand.

The use of reference materials is the basis of standardization and quality control of biologicals such as vaccines produced by different manufacturers and lot-to-lot consistency. The aim of this study was to establish a secondary local and national reference standard of adsorbed tetanus toxoid that can be used for tetanus toxoid vaccine potency testing. Concentrated bulk of tetanus toxoid was adjuvanted and aliquoted before lyophilization. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.01.006DOI Listing

A real-time PCR assay based on a specific mutation of PstS1 gene for detection of M. bovis strains.

Biologicals 2020 Mar 21;64:23-27. Epub 2020 Jan 21.

State Key Laboratory for Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, 102206, PR China; Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, 310003, PR China.

The Mycobacterium tuberculosis complex (MTBC) is composed of several genetically related and pathogenic mycobacterial species, including M. tuberculosis, M. bovis and M. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.01.007DOI Listing

Strategy and validation of a consistent and reproducible nucleic acid technique for mycoplasma detection in advanced therapy medicinal products.

Biologicals 2020 Mar 22;64:49-57. Epub 2020 Jan 22.

Unità di Medicina di Laboratorio e Biotecnologie Avanzate, IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), Via E. Tricomi 5, 90127, Palermo, Italy.

Advanced therapy medicinal products (ATMP) are required to maintain their quality and safety throughout the production cycle, and they must be free of microbial contaminations. Among them, mycoplasma contaminations are difficult to detect and undesirable in ATMP, especially for immunosuppressed patients. Mycoplasma detection tests suggested by European Pharmacopoeia are the "culture method" and "indicator cell culture method" which, despite their effectiveness, are time consuming and laborious. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.01.001DOI Listing

Comparison of accompanying proteins in different therapeutic human serum albumin preparations.

Biologicals 2020 Mar 21;64:41-48. Epub 2020 Jan 21.

Center for Extracorporeal Organ Support, Nephrology, Internal Medicine, Rostock University Medical Center, Schillingallee 68, 18057, Rostock, Germany.

Pharmaceutical human serum albumin products are manufactured from donated human plasma and may contain up to 5% accompanying non-albumin proteins. It has been reported that albumin preparations manufactured by different pharmaceutical companies differed in the degree of posttranslational modifications, the redox state as well as antioxidant properties of albumin, whereas the composition of the accompanying proteins has never been comparatively analyzed. In this study, a non-targeted mass spectrometric approach was used for label-free quantification and comparison of different pharmaceutical albumin preparations. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.01.003DOI Listing

Acidic isoforms of Erwinase form part of the product: Correlation with clinical experience.

Authors:
David Gervais

Biologicals 2020 Mar 18;64:28-33. Epub 2020 Jan 18.

Porton Biopharma Limited, Porton Down, Salisbury, Wiltshire, SP4 0JG, United Kingdom. Electronic address:

Erwinia chrysanthemil-asparaginase (ErA) has been used for the treatment of acute lymphoblastic leukaemia (ALL) for decades, and its safety and efficacy have been well demonstrated. ErA drug substance and drug product contain a small proportion of acidic isoforms, with a known mechanism of formation, which have been shown to be minor conformational variants retaining enzymatic activity and function. Specifications for these acidic isoforms were set with an extremely limited data set, and with further manufacturing experience, it can now be demonstrated that they were set too tightly. Read More

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http://dx.doi.org/10.1016/j.biologicals.2020.01.005DOI Listing

WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.

Biologicals 2020 May 17;65:50-59. Epub 2020 Jan 17.

Handok Inc, Republic of Korea.

The first global workshop on implementation of the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products adopted by the WHO Expert Committee in 2018 was held in June 2019. The workshop participants recognized that the principles based on sound science and the potential for risk, as described in the WHO Guidelines on post-approval changes, which constitute the global standard for product life-cycle management are providing clarity and helping national regulatory authorities in establishing guidance while improving time-lines for an efficient regulation of products. Consequently, the regulatory situation for post-approval changes and guideline implementation is changing but there is a disparity between different countries. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.12.008DOI Listing

A highly sensitive internally-controlled real-time PCR assay for mycoplasma detection in cell cultures.

Biologicals 2020 Mar 16;64:58-72. Epub 2020 Jan 16.

Division of Advanced Therapies, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Herts, EN6 3QG, UK. Electronic address:

Mycoplasma contamination of cell lines is a common occurrence and may affect the cell line behaviour in a variety of ways. Contamination with mycoplasma is usually not obvious so cell lines should be frequently tested. Several commercially available kits for mycoplasma detection exist, however the Ph. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.12.007DOI Listing

Development of a novel reporter gene assay for platelet-derived growth factor-BB bioactivity.

Biologicals 2020 Jan 30;63:68-73. Epub 2019 Dec 30.

Laboratory of Vaccine and Antibody Engineering, Beijing Institute of Biotechnology, Beijing, China. Electronic address:

Platelet-derived growth factors (PDGFs) are involved in various physiological and pathological processes, making them important targets for drug development. However, current methods for measuring PDGF bioactivity do not meet the rapidly growing requirements of pharmaceutical research. Here, we describe a novel reporter gene assay (RGA) for PDGF-BB activity measurement. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.11.004DOI Listing
January 2020

Isolation and characterization of phage (ETP-1) specific to multidrug resistant pathogenic Edwardsiella tarda and its in vivo biocontrol efficacy in zebrafish (Danio rerio).

Biologicals 2020 Jan 27;63:14-23. Epub 2019 Dec 27.

Fish Vaccine Research Center, Jeju National University, Jeju Self-Governing Province, 63243, Republic of Korea; Department of Marine Life Sciences, Jeju National University, Jeju Self-Governing Province, 63243, Republic of Korea. Electronic address:

Edwardsiella 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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.12.006DOI Listing
January 2020

Development of anti-drug monoclonal antibody panels against adalimumab and infliximab.

Biologicals 2020 Jan 27;63:39-47. Epub 2019 Dec 27.

Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Kanagawa, Japan.

The 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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.12.003DOI Listing
January 2020

Overexpression of microRNA-375 and microRNA-122 promotes the differentiation of human induced pluripotent stem cells into hepatocyte-like cells.

Biologicals 2020 Jan 25;63:24-32. Epub 2019 Dec 25.

Transplant Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address:

MicroRNAs (miRNAs) are involved in the regulation of gene expression. 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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.12.005DOI Listing
January 2020

The first World Health Organization International Standard for in vitro biological activity of darbepoetin.

Biologicals 2020 Jan 18;63:33-38. Epub 2019 Dec 18.

National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Hertfordshire, EN6 3QG, UK.

The 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 preparation is suitable to serve as an IS. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.12.004DOI Listing
January 2020

Quality by Design approaches to assessing the robustness of tangential flow filtration for MAb.

Biologicals 2020 Jan 14;63:53-61. Epub 2019 Dec 14.

Biologics Process 1, Biologics Research Laboratories, Dong-A Socio Holdings R&D Center, Yongin, 17073, South Korea; Department of Life Science, Sogang University, Seoul, South Korea.

Quality by Design (QbD) is a modern approach for quality assurance in pharmaceutical production. 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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.12.001DOI Listing
January 2020

Brucella abortus S19 rfbD mutant is highly attenuated, DIVA enable and confers protection against virulent challenge in mice.

Biologicals 2020 Jan 13;63:62-67. Epub 2019 Dec 13.

Division of Bacteriology and Mycology, Indian Veterinary Research Institute, Izatnagar, Uttar Pradesh, 243122, India. Electronic address:

Brucella abortus S19 is an important tool for controlling bovine brucellosis across the globe. However, vaccination with S19 suffers critical shortcomings such as, presence of residual virulence, induction of abortion and sero-diagnostic interference. In this study, rfbD gene deleted mutant S19 was developed. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.11.005DOI Listing
January 2020
1.209 Impact Factor

Potent virucidal activity against Flaviviridae of a group IIA phospholipase A isolated from the venom of Bothrops asper.

Biologicals 2020 Jan 12;63:48-52. Epub 2019 Dec 12.

Instituto Clodomiro Picado, Facultad de Microbiología, Universidad de Costa Rica, San José, Costa Rica. Electronic address:

Secreted phospholipase A (sPLA) molecules are small, calcium-dependent enzymes involved in many biological processes. Viperid venoms possess gIIA sPLAs and sPLA-like proteins, both having homology to human gIIA sPLA, an innate immunity enzyme. We evaluated the antiviral action of Mt-I (catalytically-active sPLA) and Mt-II (catalytically-inactive variant) isolated from the venom of Bothrops asper, against a diverse group of viruses. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.12.002DOI Listing
January 2020

Pragmatic rules for comparability of biological medicinal products.

Biologicals 2020 Jan 11;63:97-100. Epub 2019 Dec 11.

Medicines Evaluation Board of the Netherlands, Utrecht, the Netherlands; Department of Health Evidence, Section Biostatistics, Radboud University Medical Center, Nijmegen, the Netherlands.

Comparability 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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.11.002DOI Listing
January 2020

A class Ⅰ lentogenic newcastle disease virus strain confers effective protection against the prevalent strains.

Biologicals 2020 Jan 18;63:74-80. Epub 2019 Nov 18.

Key Laboratory of Animal Disease and Human Health of Sichuan Province, College of Veterinary Medicine, Sichuan Agricultural University, Huimin Road 211, Wenjiang, Chengdu, Sichuan, 611130, PR China. Electronic address:

The traditional vaccine strains, such as LaSota, do not completely prevent the shedding of NDV. An ideal vaccine which could not only prevent the clinical signs, but significantly reduce the shedding of NDV is urgently needed for the eradication of ND. 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. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.11.001DOI Listing
January 2020
1.209 Impact Factor

Pentaplex PCR assay for rapid differential detection of Babesia bigemina, Theileria annulata, Anaplasma marginale and Trypanosoma evansi in cattle.

Biologicals 2020 Jan 7;63:81-88. Epub 2019 Nov 7.

Division of Animal Genetics, National Bureau of Animal Genetic Resources, Karnal, Haryana, 132001, India. Electronic address:

A 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 simultaneously amplified with four target genes to avoid false-negative results. The sensitivity of mPCR was 3. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.10.011DOI Listing
January 2020

Global harmonization of vaccine testing requirements: Making elimination of the ATT and TABST a concrete global achievement.

Biologicals 2020 Jan 4;63:101-105. Epub 2019 Nov 4.

Moscow Laboratory of Control of Medicines, FSBI "IMCESACMP", Roszdravnadzor, Russia.

This one-day symposium organized by Humane Society International (HSI) brought together 18 international experts from Argentina, Brazil, China, Europe, India, Russia, South Africa and the United States to discuss the elimination of the abnormal toxicity test (ATT) from the testing requirements for human vaccines as well as the target animal batch safety test (TABST) and the laboratory animal batch safety test (LABST) for veterinary vaccines. Participants reported on country-specific regulatory requirements and, where present, the perspectives on waiver and elimination of those tests. In addition, the attendees, with HSI in the role of facilitator, moved to define the barriers to the complete elimination or waiving of these tests. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.10.007DOI Listing
January 2020

Isolation and characterization of bacteriophage to control multidrug-resistant Pseudomonas aeruginosa planktonic cells and biofilm.

Biologicals 2020 Jan 2;63:89-96. Epub 2019 Nov 2.

Department of Biotechnology, Abdul Wali Khan University, Mardan, 23200, Pakistan.

Pseudomonas 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 option for control of resistant P. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.10.003DOI Listing
January 2020
1.209 Impact Factor

Expression and purification of an immunogenic SUMO-OmpC fusion protein of Salmonella Typhimurium in Escherichia coli.

Biologicals 2019 Nov 25;62:22-26. Epub 2019 Oct 25.

National Salmonella Centre (Vet), Division of Bacteriology and Mycology, Indian Veterinary Research Institute, Izatnagar, Bareilly, 243122, U.P, India.

Salmonella is found to be a major causes of food borne diseases globally. Poultry products contaminated with this pathogen is one of the major sources of infections in humans. Outer membrane protein C (OmpC) of Salmonella Typhimurium is a promising DNA vaccine candidate to mitigate Salmonella infection in poultry. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.10.010DOI Listing
November 2019
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1.209 Impact Factor

Quality assessment and its impact on clinical performance of a biosimilar erythropoietin: A simulated case study.

Biologicals 2019 Nov 25;62:8-15. Epub 2019 Oct 25.

World Health Organization, Department of Essential Medicines and Health Products, Avenue Appia 20, CH-1211, Geneva, Switzerland.

The case study described in this paper was developed for the purpose of training for a better understanding of principles relating especially to a comprehensive evaluation of multiple quality attributes as outlined in the WHO guidelines on evaluation of similar biotherapeutic products. It is also to emphasize the importance of an understanding of the critical quality attributes and a risk assessment of the impact on clinical performance. It was prepared to mimic a real situation in which regulators need to evaluate the differences in quality attributes known to have potential impact on clinical activity. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.10.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6863428PMC
November 2019

Efficacy and safety of original and biosimilar etanercept (SB4) in active rheumatoid arthritis - A comparison in a real-world national cohort.

Biologicals 2019 Nov 24;62:27-32. Epub 2019 Oct 24.

"Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania; "Sfanta Maria" Clinical Hospital, Bucharest, Romania.

Objective: The study aims to compare the efficacy and safety of biosimilar etanercept (SB4) to original etanercept (ETN) in a real-life national cohort of rheumatoid arthritis (RA).

Methods: Data from RA patients were retrieved electronically from the Romanian Registry of Rheumatic Diseases (RRBR), which contains all patients receiving biologics in the country.

Results: The study included 242 patients with efficacy and safety data after 6 months of treatment: 123 (50. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.10.009DOI Listing
November 2019

Quality changes to approved biotherapeutic product: Simulated case studies on reporting categories & supporting data requirements.

Biologicals 2019 Nov 24;62:1-7. Epub 2019 Oct 24.

World Health Organization, Avenue Appia 20, Geneva, Switzerland. Electronic address:

Changes are essential for the continual improvement of the manufacturing process and for maintaining state-of-the-art controls on biotherapeutic products and such changes often need to be implemented after the product has been approved. WHO guidelines on procedures and data requirement for changes to approved biotherapeutic products were issued in 2017 to provide guidance to national regulatory authorities and manufacturers on the regulation of changes to already licensed biotherapeutic products in order to assure their continued quality, safety and efficacy, as well as continuity of supply and access. The case studies in this article were prepared to be used for WHO implementation workshops. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.10.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6863427PMC
November 2019

Use of NMR as an analytical tool in the process development of conjugate vaccines against Haemophilus influenzae type b (Hib) and meningococcal serogroup A (MenA).

Biologicals 2019 Nov 20;62:102-106. Epub 2019 Oct 20.

Department of Chemistry, University of Cape Town, Rondebosch, 7701, South Africa.

The native structure of the bacterial polysaccharide is the key immunogenic component of conjugate vaccines and antibodies raised against the polysaccharide structure are responsible for providing protection against the corresponding pathogen. The manufacturing process of conjugate vaccines is very complex and has various biological and chemical steps. It is important to monitor the process to ensure that the structural identity of the polysaccharide is maintained throughout the process. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.10.005DOI Listing
November 2019

In vitro differentiation of conjunctiva mesenchymal stem cells into insulin producing cells on natural and synthetic electrospun scaffolds.

Biologicals 2019 Nov 18;62:33-38. Epub 2019 Oct 18.

Department of Medical Nanotechnology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran; Zanjan Metabolic Diseases Research Center, Zanjan University of Medical Sciences, Zanjan, Iran; Zanjan Pharmaceutical Nanotechnology Research Center, Zanjan University of Medical Sciences, Zanjan, Iran. Electronic address:

Polymers are used in tissue engineering as a scaffold. In this study the differentiation capability of conjunctiva mesenchymal stem cells (CJMSCs) on natural and synthetic nanofibrous electrospun scaffolds into insulin producing cells (IPCs) were studied. Natural Silk fibroin and synthetic PLLA polymers were used to fabricate electrospun scaffolds. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.10.004DOI Listing
November 2019

Evaluation of immunogenicity and protective effect of DNA vaccine encoding surface antigen1 (SAG1) of Toxoplasma gondii and TLR-5 ligand as a genetic adjuvant against acute toxoplasmosis in BALB/c mice.

Biologicals 2019 Nov 11;62:39-49. Epub 2019 Oct 11.

Department of Medical Parasitology and Mycology, Faculty of Medicine, Shahrekord University of Medical Sciences, Shahrekord, IR, Iran. Electronic address:

Aims: Toxoplasma gondii is an obligate intracellular, protozoan that causes a high incidence of serious zoonotic parasitic disease in humans. In the present study the immune-protective efficacy of a DNA vaccine encoding SAG1 in combination with a gene sequence encoding FliC of Salmonella typhimurium (Toll-like receptor 5 agonist) was evaluated against acute T. gondii infection in mice. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.10.002DOI Listing
November 2019
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S.Typhi derived OmpC peptide conjugated with Vi-polysaccharide evokes better immune response than free Vi-polysaccharide in mice.

Biologicals 2019 Nov 9;62:50-56. Epub 2019 Oct 9.

All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.

Salmonella typhi is a causative organism for typhoid fever. Free Vi capsular polysaccharide (Vi) is licensed for use as vaccine for typhoid fever in individuals 2 years of age and older, which has limited memory response. There is dire need of protein or peptide as conjugate partner with Vi polysaccharide to improve shortcomings of Vi vaccine. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.10.001DOI Listing
November 2019
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Characterization of defective interfering (DI) particles of Pestedes petitsruminants vaccine virus Sungri/96 strain-implications in vaccine upscaling.

Biologicals 2019 Nov 3;62:57-64. Epub 2019 Oct 3.

Division of Biological Products, ICAR-Indian Veterinary Research Institute, Uttar Pradesh, India. Electronic address:

The present investigation deals with the characterization of defective interfering (DI) particles of Peste-des-petits ruminants (PPR) vaccine Sungri/96 strain generated as a result of high MOI in Vero cells. During the serial 10 passages, infectivity titres drastically reduced from 6.5 to 2. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.09.008DOI Listing
November 2019

Considering "clonality": A regulatory perspective on the importance of the clonal derivation of mammalian cell banks in biopharmaceutical development.

Biologicals 2019 Nov 3;62:16-21. Epub 2019 Oct 3.

U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Product Quality, Office of Biotechnology Products, Silver Spring, MD, USA.

There has been much recent focus on the regulatory emphasis and the relative importance surrounding clonal derivation of mammalian production cell lines used in the manufacture of recombinant DNA-derived biopharmaceuticals. This interest has led to an ongoing discussion between regulators and industry on how this topic is evaluated and the role it plays in the development of a new biopharmaceutical. Herein the authors describe that the clonal derivation of the production cell line is a factor with potential impact on product quality, and thus should not be considered separately from, but rather in the context of all elements comprising the control strategy necessary to support approval of a regulatory application. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.09.006DOI Listing
November 2019

Monoclonal antibody purification and its progression to commercial scale.

Biologicals 2020 Jan 23;63:1-13. Epub 2019 Sep 23.

Serum Institute of India Pvt. Ltd, Hadapsar, Pune, India.

With the advancements in upstream technologies, the capacity for monoclonal antibody (mAb) production has transformed from a few milligrams to grams per liter. These titers lead to enormous pressure on downstream processes (DSPs), which need to be reworked to achieve higher efficiency and better utilization of available resources. Various parameters, such as column sizing, aggregate removal, filtration and volume handling, must be considered while designing a facility for commercial scale. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.09.007DOI Listing
January 2020

Method validation of Q-PCR detection of host residual DNA in antibody drug based on protein A magnetic beads.

Biologicals 2019 Nov 18;62:65-71. Epub 2019 Sep 18.

State Key Laboratory of Antibody Research, Development, New Drug Research and Development Company Ltd., North China PharmaceuticalCorporation, Shijiazhuang, 050015, China.

The residual DNA derived from host cells in antibody drugs have potential safety risks. In this paper, the antibody in the test sample was removed by magnetic bead separation method, and the residual DNA were quantitatively determined by Q-PCR method. The residual DNA in the sample was analyzed according to the standard curve. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.09.004DOI Listing
November 2019
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1.209 Impact Factor

Collaborative study for the calibration of the replacement International Standard for pertussis toxin for use in histamine sensitisation and CHO cell clustering assays.

Biologicals 2019 Nov 13;62:85-92. Epub 2019 Sep 13.

Division of Bacteriology, National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, EN6 3QG, UK. Electronic address:

Pertussis toxin (PT) in its detoxified form is one of the major protective antigens in vaccines against Bordetella pertussis (whooping cough). Reference preparations of native PT are required for the quality control of pertussis vaccines. Stocks of the first WHO International Standard (IS) for PT (JNIH-5) were low and a replacement was required. Read More

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http://dx.doi.org/10.1016/j.biologicals.2019.09.001DOI Listing
November 2019