Aims and Scope/Editorial Board/Publishing Details
Publication date: May 2018Source: Biologicals, Volume 53Author(s): (Source: Biologicals)
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Investigation of the kinetics and mechanism of low endotoxin recovery in a matrix for biopharmaceutical drug products
Publication date: May 2018Source: Biologicals, Volume 53Author(s): Johannes Reich, Hiroshi Tamura, Isao Nagaoka, Hubert MotschmannAbstractThe inability to detect endotoxin added to undiluted drug samples has been called: Low Endotoxin Recovery (LER). The phenomenon has caused concerns amongst drug manufacturing quality control scientists in that manufactured solutions contaminated with endotoxin could show false-negative results via routine Limulus-based tests. The time-dependent appearance of LER has been analyzed in detail to provide a better understanding of the mechanism. The assumption has been that the root-cause of ...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Construction of scaffolds composed of acellular cardiac extracellular matrix for myocardial tissue engineering
This study demonstrates that the fabricated scaffold is capable of transmitting both mechanical and chemical cues that is native to myocardial tissue and supports efficient growth of the CPCs. (Source: Biologicals)
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Innovative in cellulo method as an alternative to in vivo neurovirulence test for the characterization and quality control of human live Yellow Fever virus vaccines: A pilot study
Publication date: May 2018Source: Biologicals, Volume 53Author(s): Anaelle da Costa, Christophe Prehaud, Cecile Khou, Nathalie Pardigon, Aure Saulnier, Nolwenn Nougarede, Monique LafonAbstractLive attenuated vaccines have proved to be mostly valuable in the prevention of infectious diseases in humans, especially in developing countries. The safety and potency of vaccine, and the consistency of vaccine batch-to-batch manufacturing, must be proven before being administrated to humans. For now, the tests used to control vaccine safety largely involve animal testing. For live viral vaccines, regulations require suppliers to de...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Assessing the potency and immunogenicity of inactivated poliovirus vaccine after exposure to freezing temperatures
Publication date: May 2018Source: Biologicals, Volume 53Author(s): Jessica A. White, Marcus Estrada, William C. Weldon, Konstantin Chumakov, Diana Kouiavskaia, Jacqueline Fournier-Caruana, Eric Stevens, Howard E. Gary, Edmond F. Maes, M. Steven Oberste, Cynthia J. Snider, Abhijeet Anand, Dexiang ChenAbstractAccording to manufacturers, inactivated poliovirus vaccines (IPVs) are freeze sensitive and require storage between 2°C and 8°C, whereas oral poliovirus vaccine requires storage at −20 °C. Introducing IPV into ongoing immunization services might result in accidental exposure to freezing temperatures and potential...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Establishment of the 1st WHO International Standard for anti-EV71 serum (Human)
Publication date: May 2018Source: Biologicals, Volume 53Author(s): Gillian Cooper, Qunying Mao, Laura Crawt, Yiping Wang, Thomas Dougall, Peter Rigsby, Zhenglun Liang, Miao Xu, the Collaborative Study Group, Philip Minor, Junzhi Wang, Javier MartinAbstractEnterovirus A71 (EV71) is the major causative agent of severe and fatal hand, foot and mouth disease. There is plenty of evidence that EV71 has circulated widely in the Western Pacific Region for the last twenty years. Vaccines against EV71 are already available or under development. A collaborative study to establish the 1st WHO International Standard for anti-EV71 serum...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
First evaluation of endotoxins in veterinary autogenous vaccines produced in Italy by LAL assay
Publication date: Available online 21 June 2018Source: BiologicalsAuthor(s): Di Paolo Antonella, Forti Katia, Anzalone Lucia, Corneli Sara, Pellegrini Martina, Severi Giulio, Cagiola MonicaAbstractEndotoxin 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 ai...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Detection of bovine viral diarrhoea virus nucleic acid, but not infectious virus, in bovine serum used for human vaccine manufacture
Publication date: Available online 23 June 2018Source: BiologicalsAuthor(s): Majid Laassri, Edward T. Mee, Sarah M. Connaughton, Hasmik Manukyan, Marion Gruber, Carmen Rodriguez-Hernandez, Philip D. Minor, Silke Schepelmann, Konstantin Chumakov, David J. WoodAbstractBovine 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)...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Development of a relative potency test using ELISA for human rabies vaccines
Publication date: Available online 30 June 2018Source: BiologicalsAuthor(s): Zejun Wang, Yan Sun, Xianfu Wu, Darin S. Carroll, Wenli Lv, Lei You, Yaqi Ji, Jinrong Shi, Jiaxin Yan, Gelin Xu, Shengli MengAbstractThe 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. We intended to design an alternati...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Distribution and absence of generalized lesions in mice following single dose intramuscular inoculation of the vaccine candidate MVA-MERS-S
Publication date: July 2018Source: Biologicals, Volume 54Author(s): Martin C. Langenmayer, Anna-Theresa Lülf-Averhoff, Silvia Adam-Neumair, Robert Fux, Gerd Sutter, Asisa VolzAbstractModified 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. We detected in...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Immortalization of chicken embryonic liver-derived cell line by stable expression of hMRP18S-2 for serotype 4 fowl adenovirus propagation
Publication date: July 2018Source: Biologicals, Volume 54Author(s): Lei Feng, Li Chen, Junwen Yun, Zhixiang Bi, Yinghua Tang, Peipei Wu, Jibo HouAbstractInclusion 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. The maximum cell density of CEL-hMRP18S-2 cells...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Aims and Scope/Editorial Board/Publishing Details
Publication date: July 2018Source: Biologicals, Volume 54Author(s): (Source: Biologicals)
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Host cell protein testing strategy for hepatitis B antigen in Hexavalent vaccine – Towards a general testing strategy for recombinant vaccines
ConclusionsAnalysis of multiple HBsAg batches showed consistent HCP content and identification profiles, as well as product purity and specific antigen content, demonstrating consistent manufacturing process. Recombinant vaccines, unlike therapeutic products, are administered infrequently with only small amounts of protein injected at a time. With limited potential for adverse reactions to small quantities of HCPs in purified recombinant vaccine antigens, and considering the relevant regulatory guidelines, we conclude that once consistent manufacturing process has been demonstrated, routine HCP testing in recombinant vacci...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
Drug survival of biologic therapies for the treatment of psoriasis: Results of Slovenian national registry
Publication date: July 2018Source: Biologicals, Volume 54Author(s): Tomaz Lunder, Pij Marko, Natasa Koser Kolar, Boris Kralj, Nada Kecelj LeskovecAbstractThe 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 (...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
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
Publication date: July 2018Source: Biologicals, Volume 54Author(s): Maryam Rahimi, Amir-Hassan Zarnani, Sahba Mobini, Somaieh Khorasani, Maryam Darzi, Somaieh KazemnejadAbstractThe 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...
Source: Biologicals - July 11, 2018 Category: Biology Source Type: research
