Aims and Scope/Editorial Board/Publishing Details
Publication date: May 2018Source: Biologicals, Volume 53Author(s): (Source: Biologicals)
Source: Biologicals - July 5, 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 5, 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 5, 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 5, 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 5, 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 5, 2018 Category: Biology Source Type: research
Identification of T cell and B cell epitopes against Indian HCV-genotype-3a for vaccine development- An in silico analysis
Publication date: May 2018Source: Biologicals, Volume 53Author(s): Varun Chauhan, Mini P. Singh, Radha K. RathoAbstractHepatitis C virus (HCV) infects almost 150 million people and is a leading cause of liver disease worldwide. It has been classified into seven genotypes; the most common genotype affecting Indian population is genotype 3 (60–70%). Currently there is no vaccine for any genotype of HCV. In order to develop peptide based vaccine against HCV, it is important to identify the conservancy in the circulating genotypes, along with the Human Leucocyte Antigen (HLA) alleles in the target population. The present stu...
Source: Biologicals - July 5, 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: Available online 8 May 2018Source: BiologicalsAuthor(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...
Source: Biologicals - July 5, 2018 Category: Biology Source Type: research
Adherence to biologic therapy – Does it vary with ethnicity?
ConclusionTo our knowledge, this is the first study to demonstrate ethnic differences in disease activity score and related negative beliefs regarding subcutaneous biologic therapies in people with rheumatic diseases. (Source: Biologicals)
Source: Biologicals - July 5, 2018 Category: Biology Source Type: research
Development of a highly sensitive PCR/DNA chip method to detect mycoplasmas in a veterinary modified live vaccine
Publication date: Available online 10 May 2018Source: BiologicalsAuthor(s): Sylvie Mbelo, Virginie Gay, Stephanie Blanchard, Eric Abachin, Stephanie Falque, Jacques Lechenet, Hervé Poulet, Blandine de Saint-VisAbstractMycoplasmas 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. Previously, ...
Source: Biologicals - July 5, 2018 Category: Biology Source Type: research
Development of an anti-EPO antibody detection kit based on lab-on-a-chip and bridging antibody technologies
Publication date: Available online 17 May 2018Source: BiologicalsAuthor(s): Jin-Gyo Oh, Jihyun Seong, Sunmi Han, Tae-Hwe HeoAbstractImmunogenicity 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. Here, the new method was developed based on lab-on-a-chip technology and bridgin...
Source: Biologicals - July 5, 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 5, 2018 Category: Biology Source Type: research
Electrospun composite PLLA/Oyster shell scaffold enhances proliferation and osteogenic differentiation of stem cells
Publication date: Available online 2 June 2018Source: BiologicalsAuthor(s): Roghaieh Didekhani, Mahmoud Reza Sohrabi, Ehsan Seyedjafari, Masoud Soleimani, Hana Hanaee-AhvazAbstractIn 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 tissu...
Source: Biologicals - July 5, 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: Available online 6 June 2018Source: BiologicalsAuthor(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-specif...
Source: Biologicals - July 5, 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 5, 2018 Category: Biology Source Type: research
