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    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 Jun 5. Epub 2018 Jun 5.
    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

    Electrospun composite PLLA/Oyster shell scaffold enhances proliferation and osteogenic differentiation of stem cells.
    Biologicals 2018 Jun 2. 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

    Host cell protein testing strategy for hepatitis B antigen in Hexavalent vaccine - Towards a general testing strategy for recombinant vaccines.
    Biologicals 2018 May 31. 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

    Development of an anti-EPO antibody detection kit based on lab-on-a-chip and bridging antibody technologies.
    Biologicals 2018 May 17. 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

    Coculture of conjunctiva derived mesenchymal stem cells (CJMSCs) and corneal epithelial cells to reconstruct the corneal epithelium.
    Biologicals 2018 May 15. Epub 2018 May 15.
    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

    Distribution and absence of generalized lesions in mice following single dose intramuscular inoculation of the vaccine candidate MVA-MERS-S.
    Biologicals 2018 May 11. Epub 2018 May 11.
    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

    Adherence to biologic therapy - Does it vary with ethnicity?
    Biologicals 2018 May 9. 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

    Development of a highly sensitive PCR/DNA chip method to detect mycoplasmas in a veterinary modified live vaccine.
    Biologicals 2018 May 9. Epub 2018 May 9.
    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

    Immortalization of chicken embryonic liver-derived cell line by stable expression of hMRP18S-2 for serotype 4 fowl adenovirus propagation.
    Biologicals 2018 May 8. 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

    Drug survival of biologic therapies for the treatment of psoriasis: Results of Slovenian national registry.
    Biologicals 2018 Apr 26. 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

    Investigation of the kinetics and mechanism of low endotoxin recovery in a matrix for biopharmaceutical drug products.
    Biologicals 2018 May 21;53:1-9. Epub 2018 Apr 21.
    Institute of Physical and Theoretical Chemistry, University of Regensburg, Regensburg, Germany.
    The 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. Read More

    Construction of scaffolds composed of acellular cardiac extracellular matrix for myocardial tissue engineering.
    Biologicals 2018 May 3;53:10-18. Epub 2018 Apr 3.
    Aerospace Research Institute, Ministry of Science Research and Technology, Tehran, 14665-834, Iran.
    High rates of mortality and morbidity stemming from cardiovascular diseases unveil extreme limitations in current therapies despite enormous advances in medical and pharmaceutical sciences. Following myocardial infarction (MI), parts of myocardium undergo irreversible remodeling and is substituted by a scar tissue which eventually leads to heart failure (HF). To address this issue, cardiac patches have been utilized to initiate myocardial regeneration. Read More

    Regulatory pathways to enable the licencing of alternatives to antibiotics.
    Biologicals 2018 May 31;53:72-75. Epub 2018 Mar 31.
    Office of National Programs, Animal Production and Protection, 5601 Sunnyside Avenue, George Washington Carver Center, Beltsville, MD, USA.
    Effective alternatives to antibiotics (ATA) such as vaccines, antibodies, phage therapies, prebiotics, probiotics and herbal medicines can be used in place of traditional antibiotics in a way that does not compromise animal health as means of tackling the growing threat to both animal and human health from antimicrobial resistance (AMR). This paper reflects the key points on the approaches that were discussed during the 2nd International Symposium on ATA between regulatory agencies, veterinary product companies representing largely the pharmaceutical and feed-additive sectors, academia and other stakeholders on regulatory pathways to enable the licensing of alternatives to antibiotics for food producing animals. The need to demonstrate compliance with generally accepted standards for quality, safety and efficacy is considered a pre-requisite for all veterinary medicinal products receiving an authorisation including ATA, irrespective of the region in which they are approved. Read More

    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.
    Biologicals 2018 May 24;53:19-29. Epub 2018 Mar 24.
    Institut Pasteur, CNRS UMR 3569, Unité de Neuroimmunologie Virale, 25 Rue du Dr Roux, 75724, Paris Cedex 15, France. Electronic address:
    Live 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. Read More

    Human challenge trials in vaccine development, Rockville, MD, USA, September 28-30, 2017.
    Biologicals 2018 Mar 21. Epub 2018 Mar 21.
    International Alliance for Biological Standardization, Lyon, France. Electronic address:
    The International Alliance for Biological Standardization organized the second workshop on human challenge trials (HCT) in Rockville, MD, in September 2017. The objective of this meeting was to examine the use of HCT, in response to the continuing human suffering caused by infectious diseases, preventable by the development of new and improved vaccines. For this, the approach of HCT could be valuable, as HCT can provide key safety, tolerability, immunogenicity, and efficacy data, and can be used to study host-pathogen biology. Read More

    Establishment of the 1st WHO International Standard for anti-EV71 serum (Human).
    Biologicals 2018 May 20;53:39-50. Epub 2018 Mar 20.
    Division of Virology, Beijing 100050, China. Electronic address:
    Enterovirus 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. Read More

    Assessing the potency and immunogenicity of inactivated poliovirus vaccine after exposure to freezing temperatures.
    Biologicals 2018 May 14;53:30-38. Epub 2018 Mar 14.
    PATH, PO Box 900922, Seattle, WA 98109, USA.
    According 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 loss of vaccine potency. To better understand the effect of freezing IPVs, samples of single-dose vaccine vials from Statens Serum Institut (VeroPol) and multi-dose vaccine vials from Sanofi Pasteur (IPOL) were exposed to freezing temperatures mimicking what a vaccine vial might encounter in the field. Read More

    Identification of T cell and B cell epitopes against Indian HCV-genotype-3a for vaccine development- An in silico analysis.
    Biologicals 2018 May 5;53:63-71. Epub 2018 Mar 5.
    Department of Virology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, Punjab 160012, India.
    Hepatitis 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. Read More

    Poly(lactic-co-glycolic acid)(PLGA)/TiO nanotube bioactive composite as a novel scaffold for bone tissue engineering: In vitro and in vivo studies.
    Biologicals 2018 May 2;53:51-62. Epub 2018 Mar 2.
    Marquette University School of Dentistry, Milwaukee, WI 53233, USA.
    The aim of this study was to synthesize and characterize novel three-dimensional porous scaffolds made of poly (lactic-co-glycolic acid)/TiO nanotube (TNT) composite microspheres for bone tissue engineering applications. The incorporation of TNT greatly increases mechanical properties of PLGA/TNT microsphere-sintered scaffold. The experimental results exhibit that the PLGA/0. Read More

    Evaluation of the use of various rat strains for immunogenic potency tests of Sabin-derived inactivated polio vaccines.
    Biologicals 2018 Mar 21;52:12-17. Epub 2018 Feb 21.
    Department of Virology II, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashi-Murayama, Tokyo 208-0011, Japan.
    Slc:Wistar rats have been the only strain used in Japan for purpose of evaluating a national reference vaccine for the Sabin-derived inactivated polio vaccine (sIPV) and the immunogenicity of sIPV-containing products. However, following the discovery that the Slc:Wistar strain was genetically related to the Fischer 344 strain, other "real" Wistar strains, such as Crlj:WI, that are available worldwide were tested in terms of their usefulness in evaluating the immunogenicity of the past and current lots of a national reference vaccine. The response of the Crlj:WI rats against the serotype 1 of sIPV was comparable to that of the Slc:Wistar rats, while the Crlj:WI rats exhibited a higher level of response against the serotypes 2 and 3. Read More

    Enhanced chondrogenesis differentiation of human induced pluripotent stem cells by MicroRNA-140 and transforming growth factor beta 3 (TGFβ3).
    Biologicals 2018 Mar 16;52:30-36. Epub 2018 Feb 16.
    Department of Biotechnology, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran; Cellular and Molecular Biology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address:
    Induced pluripotent stem cells (iPSCs) make an attractive source for regenerative medicine. The objective of our study was to establish a new method for differentiation of human iPSCs toward chondrocyte by overexpression of MicroRNA-140 (miR-140) and use of transforming growth factor beta 3 (TGFβ3) in high-cell density culture systems. We prepared vectors and then was used for recombinant Lenti virus production in HEK-293 cell. Read More

    Validation and implementation of Planova™ BioEX virus filters in the manufacture of a new liquid intravenous immunoglobulin in China.
    Biologicals 2018 Mar 9;52:37-43. Epub 2018 Feb 9.
    Shandong Taibang Biological Products Co., Ltd., No. 14 East Hushan Road, Taian City, Shandong 271000, China. Electronic address:
    There is a continuous need to improve the viral safety of plasma products, and we here report the development and optimization of a manufacturing-scale virus removal nanofiltration step for intravenous immunoglobulin (IVIG) using the recently introduced Planova™ BioEX filter. IVIG throughput was examined for various operating parameters: transmembrane pressure, temperature, protein concentration, and prefiltration methods. The developed procedure was based on filtering undiluted process solution (50. Read More

    Evaluation of cellular immunogenicity of recombinant cytochrome p450 cyp141 protein of Mycobacterium tuberculosis in human and mouse model.
    Biologicals 2018 Mar 7;52:25-29. Epub 2018 Feb 7.
    Department of Microbiology and Immunology, Cellular and Molecular Research Center, Sharekord University of Medical Sciences, Sharekord, IR, Iran. Electronic address:
    Mycobacterium tuberculosis (Mtb) is still considered one of the unsolved problems for the World Health Organization Identifying and selecting an immunogenic antigen capable of generating specific immune responses is generally the goal of all studies being carried out in to designing new vaccines. Accordingly, the present study was conducted to evaluate the immunogenicity of a M. tuberculosis recombinant protein which exist in the regions of the bacterium genome and may be an immunogenic protein. Read More

    Sex bias in mouse humoral immune response to influenza vaccine depends on the vaccine type.
    Biologicals 2018 Mar 14;52:18-24. Epub 2018 Feb 14.
    Department of Physiology, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia. Electronic address:
    The study explored influence of biological sex on development of humoral immune response to seasonal trivalent whole inactivated virus (WIV) and split virus (SV) influenza vaccines in outbred Swiss mouse model. To this end, mice of both sexes were immunized with WIV (WIV mice) and SV vaccines (SV mice) and examined for specific antibody response. Irrespective of sex, total IgG and neutralizing antibody responses to distinct virus strains were weaker in SV than in WIV mice. Read More

    Comparison of reverse-transcriptase qPCR and droplet digital PCR for the quantification of dengue virus nucleic acid.
    Biologicals 2018 Mar 3;52:49-54. Epub 2018 Feb 3.
    Analytical R&D Department, Microbiology Characterization R&D Unit, Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy l'Etoile, France. Electronic address:
    Polymerase chain reaction (PCR) is an important molecular biology technique for in vitro amplification of nucleic acids. Reverse transcriptase quantitative PCR (RT-qPCR) and more recently reverse transcriptase digital droplet PCR (RT-ddPCR) have been developed for the quantification of nucleic acids. We developed an RT-ddPCR assay for the quantification of attenuated dengue virus serotype 2 nucleic acid and compared it with a routine RT-qPCR assay. Read More

    Distinct effect of fetal bovine serum versus follicular fluid on multipotentiality of human granulosa cells in in vitro condition.
    Biologicals 2018 Mar 3;52:44-48. Epub 2018 Feb 3.
    Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address:
    This study aimed to develop an appropriate medium for preservation of multipotentiality in human granulosa cells. To compare the possible effect of different media supplemented with follicular fluid or fetal bovine serum, granulosa cells were cultured in vitro over a period of 14 days. Stemness feature and any alteration in the cell phenotype were monitored using colony count assay and flow cytometry analysis by monitoring the expression of Oct3/4 and GATA-4 factors. Read More

    Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies.
    Biologicals 2018 Mar 1;52:78-82. Epub 2018 Feb 1.
    Zoetis, UK. Electronic address:
    Within the Innovative Medicines Initiative 2 (IMI 2) project VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing), a workshop has been organised to discuss ways of improving the design of multi-centre validation studies and use the data generated for product-specific validation purposes. Moreover, aspects of validation within the consistency approach context were addressed. This report summarises the discussions and outlines the conclusions and recommendations agreed on by the workshop participants. Read More

    Mass spectrometry analysis reveals differences in the host cell protein species found in pseudotyped lentiviral vectors.
    Biologicals 2018 Mar 1;52:59-66. Epub 2018 Feb 1.
    Division of Advanced Therapies, National Institute for Biological Standards and Control, Blanche Lane, Potters Bar, EN6 3QG, UK. Electronic address:
    Lentiviral vectors (LVs) have been successfully used in clinical trials showing long term therapeutic benefits. Studying the role of cellular proteins in lentivirus HIV-1 life cycle can help understand virus assembly and budding, leading to improvement of LV production for gene therapy. Lentiviral vectors were purified using size exclusion chromatography (SEC). Read More

    Biochemical characterization, stability, and pathogen safety of a new fibrinogen concentrate (fibryga).
    Biologicals 2018 Mar 12;52:72-77. Epub 2018 Jan 12.
    Octapharma Pharmazeutika Produktionsgesellschaft mbH, R&D Plasma Vienna, Oberlaaerstraße 235, 1100 Vienna, Austria.
    Fibryga is a new lyophilized fibrinogen concentrate for intravenous use for the treatment of congenital fibrinogen deficiency. fibryga is produced from pooled human plasma and the final product is characterized by high purity, integrity, and pathogen safety. Functional activity of fibrinogen was demonstrated by cross-linking studies and thromboelastometry; integrity of the fibrinogen molecule was demonstrated by size exclusion chromatography and the detection of only trace amounts of activation markers in the final product. Read More

    Directly injected native bone-marrow stem cells cannot incorporate into acetaminophen-induced liver injury.
    Biologicals 2018 Mar 6;52:55-58. Epub 2018 Jan 6.
    Cell-Based Therapies Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address:
    The paucity of liver donation highlights the use of cell-based strategies for end-stage liver failure. We recently showed that bone marrow-derived aggregates (BMDAs) can completely restore the hematopoietic system in gamma-irradiated mice. These aggregates are stem and progenitor cells in the bone marrow (BM), composed of both hematopoietic and non-hematopoietic lineages. Read More

    Humoral and cellular immune response in mice induced by the classical swine fever virus E2 protein fused to the porcine CD154 antigen.
    Biologicals 2018 Mar 5;52:67-71. Epub 2018 Jan 5.
    Animal Biotechnology Department, Center for Genetic Engineering and Biotechnology, POBox 6162, Havana 10600, Cuba.
    The development of subunit vaccines against classical swine fever is a desirable goal, because it allows discrimination between vaccinated and infected animals. In this study, humoral and cellular immune response elicited in inbred BALB/c mice by immunization with a recombinant classical swine fever virus (CSFV) E2 protein fused to porcine CD154 antigen (E2CD154) was assessed. This model was used as a predictor of immune response in swine. Read More

    WHO informal consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 27-28 April 2017.
    Biologicals 2018 Mar 27;52:83-91. Epub 2017 Dec 27.
    Department of Medical Sciences, Ministry of Public Health, Tivanon Road, Nonthaburi 11000, Thailand. Electronic address:
    In April 2017, WHO convened an informal consultation to develop WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products. The objective of the meeting was to review the draft of WHO guidelines and the comments received from the public consultation. The guidelines were recognized by the participants as a tool for regulatory convergence and harmonization. Read More

    An ELISA for quantification of recombinant human EGF in production process samples, serum and urine.
    Biologicals 2018 Jan 12;51:12-17. Epub 2017 Dec 12.
    Monoclonal Antibody Production Department, Center for Genetic Engineering and Biotechnology, P.O. Box 6162, Havana 10600, Cuba.
    A sandwich enzyme-linked immunosorbent assay for quantifying a recombinant human Epidermal Growth Factor (rhEGF) protein used in a vacunal preparation is described. The protein was detected with high specificity in a short incubation time at elevated temperature, the assay showing a linear range between 0.0625 and 1 ng/mL. Read More

    Therapeutic monoclonal antibody N-glycosylation - Structure, function and therapeutic potential.
    Biologicals 2018 Mar 26;52:1-11. Epub 2017 Nov 26.
    Pharma Technical Development Analytics Biologics, Roche Diagnostics GmbH, Nonnenwald 2, D-82377, Penzberg, Germany.
    Therapeutic antibodies (IgG-type) contain several post-translational modifications (PTMs) whereby introducing a large heterogeneity, both structural and functional, into this class of therapeutics. Of these modifications, glycosylation in the fragment crystallizable (Fc) region is the most heterogeneous PTM, which can affect the stability of the molecule and interactions with Fc-receptors in vivo. Hence, the glycoform distribution can affect the mode of action and have implications for bioactivity, safety and efficacy of the drug. Read More

    High-level expression and immunogenicity of porcine circovirus type 2b capsid protein without nuclear localization signal expressed in Hansenula polymorpha.
    Biologicals 2018 Jan 7;51:18-24. Epub 2017 Dec 7.
    Department of Molecular Biology in College of Basic Medical Sciences and Institute of Pediatrics in First Hospital, Jilin University, Changchun 130021, China. Electronic address:
    Currently, porcine circovirus type 2b (PCV2b) is the dominant PCV2 genotype causing postweaning multisystemic wasting disease (PMWS) in pigs worldwide. Efforts have been made to develop various recombinant capsid proteins of PCV2b used in vaccines against PCV2b. However, the nuclear localization signal (NLS) of PCV2b capsid protein (CP) was found to inhibit the expression of the whole length capsid protein in E. Read More

    Stability of virus-like particles of red-spotted grouper nervous necrosis virus in the aqueous state, and the vaccine potential of lyophilized particles.
    Biologicals 2018 Jan 22;51:25-31. Epub 2017 Nov 22.
    Laboratory of Virology, College of Pharmacy, Chung-Ang University, 84 Heukseok-Ro, Dongjak-Gu, Seoul 06974, South Korea. Electronic address:
    Virus-like particles (VLPs) are multi protein complexes mimicking the structural properties of the native virus. The development of freeze-dried formulations of such complex protein structures remains a challenge. Red-spotted grouper nervous necrosis virus (RGNNV) causes mass mortality in fish culture, and RGNNV VLPs have been suggested to be promising vaccine candidates. Read More

    Screening for viral extraneous agents in live-attenuated avian vaccines by using a microbial microarray and sequencing.
    Biologicals 2018 Jan 11;51:37-45. Epub 2017 Nov 11.
    Virus Research and Development Laboratory, Department of Microbiological Diagnostics and Virology, Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark. Electronic address:
    The absence of extraneous agents (EA) in the raw material used for production and in finished products is one of the principal safety elements related to all medicinal products of biological origin, such as live-attenuated vaccines. The aim of this study was to investigate the applicability of the Lawrence Livermore Microbial detection array version 2 (LLMDAv2) combined with whole genome amplification and sequencing for screening for viral EAs in live-attenuated vaccines and specific pathogen-free (SPF) eggs. We detected positive microarray signals for avian endogenous retrovirus EAV-HP and several viruses belonging to the Alpharetrovirus genus in all analyzed vaccines and SPF eggs. Read More

    Preparation and immunological evaluation of inactivated avian influenza virus vaccine encapsulated in chitosan nanoparticles.
    Biologicals 2018 Jan 8;51:46-53. Epub 2017 Nov 8.
    Analysis & Evaluation Department, Egyptian Petroleum Research Institute, 11727, Cairo, Egypt. Electronic address:
    Efficacy maximization of inactivated avian influenza vaccine using safe adjuvants was investigated. Chitosan nanoparticles were prepared by ionic gelation method with average size of 150 nm and their Zeta potential was 11.5 mV. Read More

    Successful removal of porcine circovirus-1 from immunoglobulin G formulated in glycine solution using nanofiltration.
    Biologicals 2018 Jan 7;51:32-36. Epub 2017 Nov 7.
    Research and Development Division, Japan Blood Products Organization, Hyogo, Japan; Manufacturing Technology Association of Biologics, Tokyo, Japan. Electronic address:
    Porcine circovirus (PCV) is a potentially harmful virus that has been shown to contaminate biological products. The virus is resistant to many inactivation and/or removal procedures performed during manufacturing. Anion exchange chromatography has been shown to be useful for PCV type 1 (PCV1) removal; however, reduction of PCV1 using methods such as heat inactivation, low pH, nanofiltration, UV-C, and gamma irradiation has not been successful. Read More

    Analysis of the proficiency of single radial immunodiffusion assays for quality control of influenza vaccines in Korea.
    Biologicals 2017 Nov 28;50:137-140. Epub 2017 Oct 28.
    Vaccines Division, National Institute of Food and Drug Safety Evaluation, 187 Osongsaengmyeoung 2-ro, Osong-eup, Heungdoek-gu, Cheongju 28159, Republic of Korea. Electronic address:
    Influenza vaccine potency, which is determined by quantitatively measuring the content of Hemagglutinin (HA), is an essential index representing the efficacy of the vaccine. Standardization of the single radial immunodiffusion (SRID) assay, a method for measuring HA content, and proficiency of the testing institutions are crucial for influenza vaccine quality control. Herein, we assessed the proficiency of SRID assays at the National Control Laboratory (NCL) of Korea and several vaccine manufacturers. Read More

    A novel protocol to provide a suitable cardiac model from induced pluripotent stem cells.
    Biologicals 2017 Nov 27;50:42-48. Epub 2017 Oct 27.
    Department of Genetics, Faculty of Biological Sciences, Tarbiat Modares University, Tehran, Iran.
    Cumulative evidence has proven the safety, feasibility and efficacy of stem cell therapy for cardiomyocyte replacement in heart failure treatment. In contrast to embryonic stem cells, induced pluripotent stem cells (iPS cells) provide a route to the production of patient-specific stem cell lines with no ethical concerns. Recent studies have revealed that myogenic transcription factors activated the expression of conserved microRNAs (miRNAs), such as mir-1, that 'fine-tuned' the output of the transcriptional networks. Read More

    Characterisation of the site-specific monoPEGylated rhG-CSF analogue pegteograstim.
    Biologicals 2018 Jan 26;51:54-61. Epub 2017 Oct 26.
    Department of Biotechnology, College of Life Sciences and Biotechnology, Korea University, 136-701, Anam-dong, Seoungbuk-gu, Seoul, Republic of Korea. Electronic address:
    We describe the characterisation of a novel monoPEGylated recombinant human granulocyte colony-stimulating factor analogue, pegteograstim (Neulapeg), prepared by site-specific 20 kDa maleimide-PEG conjugation. An additional cysteine was inserted between Gly136 and Ala137 of filgrastim (methionyl human granulocyte colony-stimulating factor) for site-specific PEGylation, and Cys18 of filgrastim was replaced with Ser18 to prevent unwanted PEGylation. Pegteograstim was produced by Escherichia coli and purified by cation exchange chromatography, and its structural, physicochemical, biological and immunological properties were investigated. Read More

    Current status and future prospective of vaccine development against Echinococcus granulosus.
    Biologicals 2018 Jan;51:1-11
    Research Center for Pharmaceutical Nanotechnology, Biomedicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran; School of Advanced Biomedical Sciences, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Pharmaceutics, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address:
    Cystic echinococcosis (CE) is one of the most important zoonotic parasite diseases in human, livestock, and wildlife worldwide. Development of effective vaccines against CE appears to be the most promising strategy to control this infectious disease. Use of potential livestock and canine vaccines against the larval and adult stage of E. Read More

    Binding and neutralizing anti-cytomegalovirus activities in immune globulin products.
    Biologicals 2017 Nov 10;50:35-41. Epub 2017 Oct 10.
    Plasma Derivatives Branch, Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies, CBER, FDA, United States. Electronic address:
    Congenital infection as well as infection of immunocompromised individuals by cytomegalovirus (CMV) can be associated with significant morbidity, mortality, and long-term adverse health outcomes. Assessment of anti-viral activity using appropriate assays is essential for ensuring safe and efficacious use of therapeutic CMV immune globulin (IG) products. In this study, we used commercial ELISA kits to compare anti-CMV antibody binding activity and avidity for lots of CMV-specific and normal IG products available in the US market. Read More

    Oxidation of M252 but not M428 in hu-IgG1 is responsible for decreased binding to and activation of hu-FcγRIIa (His131).
    Biologicals 2017 Nov 5;50:125-128. Epub 2017 Oct 5.
    Pharma Technical Development Analytics Biologics, F. Hoffmann-La Roche Ltd., 4070 Basel, Switzerland.
    Oxidation of monoclonal therapeutic antibodies (mAbs) can affect binding to Fc-receptors and potentially influence pharmacokinetics or effector functions like e.g. antibody dependent cellular phagocytosis (ADCP). Read More

    Biophysical characterization and structure of the Fab fragment from the NIST reference antibody, RM 8671.
    Biologicals 2017 Nov 29;50:27-34. Epub 2017 Sep 29.
    Biomolecular Measurement Division, National Institute of Standards & Technology, Rockville, MD 20850, USA; Institute for Bioscience and Biotechnology Research, 9600 Gudelsky Drive, Rockville, MD 20850, USA. Electronic address:
    Monoclonal antibody pharmaceuticals are the fastest-growing class of therapeutics, with a wide range of clinical applications. To assure their safety, these protein drugs must demonstrate highly consistent purity and stability. Key to these objectives is higher order structure measurements validated by calibration to reference materials. Read More

    Evaluation of the combined effects of pegylation and glycosylation on the stability of erythropoietin using a stability-indicating SE-HPLC.
    Biologicals 2017 Nov 27;50:129-136. Epub 2017 Sep 27.
    Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Egypt.
    Recombinant human erythropoietin (rhEPO) is a commonly used biopharmaceutical for the treatment of anemia-associated disorders. Epogen; glycosylated erythropoietin (G-EPO) has short half-life and poor stability. Pegylated Epogen (Peg-G-EPO) was introduced to the market to overcome these limitations. Read More

    Validation of a PCR coupled to a microarray method for detection of mycoplasma in vaccines.
    Biologicals 2017 Nov 23;50:55-62. Epub 2017 Sep 23.
    Analytical Research and Development, Sanofi Pasteur, 69280 Marcy l'Etoile, France.
    The revised section of the European, United States, and Japan Pharmacopeias on mycoplasma testing provided guidance for the set up and validation of a nucleic acid amplification technique (NAT) as an alternative method to agar culture and indicator cell culture compendial methods. The CytoInspect™ method, based on Polymerase Chain Reaction (PCR) coupled to microarray analysis, has been selected for detection and identification of mycoplasma in vaccines. To replace compendial methods, the alternative method must demonstrate equivalence in both limit of detection (LOD) and specificity compared with compendial methods. Read More

    Differentiation of mesenchymal stem cells -derived trabecular meshwork into dopaminergic neuron-like cells on nanofibrous scaffolds.
    Biologicals 2017 Nov 21;50:49-54. Epub 2017 Sep 21.
    Department of Medical Biotechnology and Nanotechnology, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran; Cancer and Gene Therapy Research Center, Zanjan University of Medical Sciences, Zanjan, Iran. Electronic address:
    Parkinson's disease (PD) is a neurodegenerative disorder of the brain which is produced by the damage to dopaminergic neurons. Stem cell transplantation with a nanofibrous scaffold is one of the encouraging strategies for Parkinson's disease therapy. In this study, human mesenchymal stem cells (MSCs) from eye trabecular meshwork (TM) were differentiated into dopaminergic neurons on nanofibrous scaffold. Read More

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