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Biologicals: Journal of the International Association of Biological Standardization

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https://www.readbyqxmd.com/read/29336864/biochemical-characterization-stability-and-pathogen-safety-of-a-new-fibrinogen-concentrate-fibryga%C3%A2
#1
Petra M Schulz, Werner Gehringer, Sabine Nöhring, Sebastian Müller, Torben Schmidt, Stephanie Kekeiss-Schertler, Cristina Solomon, Katharina Pock, Jürgen Römisch
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...
January 11, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29317122/directly-injected-native-bone-marrow-stem-cells-cannot-incorporate-into-acetaminophen-induced-liver-injury
#2
Azadeh Babaei, Azam Katoonizadeh, Azam Ranjbar, Mahmood Naderi, Naser Ahmadbeigi
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. Furthermore, reports showed that resident BM cells migrate to the liver and integrate themselves into the tissue in small numbers. Hence, we hypothesized that direct delivery of BMDAs to the damaged liver might enhance the integration of BM cells in the liver because of its stemness property, intact BM architecture, the physical proximity of these niche-like structures to the damaged sites and the existence of liver paracrine factors...
January 6, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29311002/humoral-and-cellular-immune-response-in-mice-induced-by-the-classical-swine-fever-virus-e2-protein-fused-to-the-porcine-cd154-antigen
#3
Yusmel Sordo, Marisela Suárez, Rosalina Caraballo, Talía Sardina, Emma Brown, Carlos Duarte, Joanna Lugo, Lázaro Gil, Danny Perez, Ayme Oliva, Milagros Vargas, Elaine Santana, Rodolfo Valdés, María Pilar Rodríguez
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. Mice were immunized with E2CD154 emulsified in Montanide ISA50V2 or dissolved in saline on days 1 and 21...
January 5, 2018: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29289489/meeting-report-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
#4
Meenu Wadhwa, Hye-Na Kang, Hugo Hamel, Teeranart Jivapaisarnpong
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. Regulation of changes to approved biotherapeutic products is a key in ensuring that products of consistent quality, safety and efficacy are distributed after they receive authorization or licensure...
December 27, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29246787/an-elisa-for-quantification-of-recombinant-human-egf-in-production-process-samples-serum-and-urine
#5
Alberto Leyva, Hector Santana, Milagros Font, Barbara Pérez, Rodolfo Valdés
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. According to the regression analysis for the dilutional linearity data, r2 = 0.9998, slope = 1.07 and intercept = 0.05 were obtained. The intra- and inter-assay coefficient of variation, ranged from 0...
December 12, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29225046/high-level-expression-and-immunogenicity-of-porcine-circovirus-type-2b-capsid-protein-without-nuclear-localization-signal-expressed-in-hansenula-polymorpha
#6
Yue Xiao, Peiyan Zhao, Junyang Du, Xin Li, Wenting Lu, Xu Hao, Boqi Dong, Yongli Yu, Liying Wang
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.coli. Here, we expressed a NLS-deleted capsid protein (ΔCP) of PCV2b in Hansenula polymorpha based on the capsid protein of PCV2b strain Y-7 isolated in China...
December 7, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29239840/therapeutic-monoclonal-antibody-n-glycosylation-structure-function-and-therapeutic-potential
#7
REVIEW
Florian Cymer, Hermann Beck, Adelheid Rohde, Dietmar Reusch
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...
November 24, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29174141/stability-of-virus-like-particles-of-red-spotted-grouper-nervous-necrosis-virus-in-the-aqueous-state-and-the-vaccine-potential-of-lyophilized-particles
#8
Nguyen Thi Lan, Hyoung Jin Kim, Hyun-Ja Han, Deok-Chan Lee, Bo Kyu Kang, Sang Yoon Han, Hyoungjoon Moon, Hong-Jin Kim
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. In the present study, the stability of RGNNV VLPs in the liquid state was investigated over a 4-week period, along with the influence of freeze-drying on VLP stability...
November 22, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29132963/screening-for-viral-extraneous-agents-in-live-attenuated-avian-vaccines-by-using-a-microbial-microarray-and-sequencing
#9
Majken Lindholm Olesen, Lotte Leick Jørgensen, Merete Blixenkrone-Møller, Eva Sandberg, Peer Lyng Frandsen, Erik Østergaard, Eva Rauhe Bækdahl, Helena Fridholm, Anders Fomsgaard, Maiken Worsøe Rosenstierne
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...
November 10, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29126666/preparation-and-immunological-evaluation-of-inactivated-avian-influenza-virus-vaccine-encapsulated-in-chitosan-nanoparticles
#10
Samah H Mohamed, Abdel Satar Arafa, Wesam H Mady, Hanan A Fahmy, Lamiaa M Omer, Rania E Morsi
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. After encapsulation of avian influenza vaccine, the average size was 397 nm and Zeta potential was 4.29 mV. The highest HI antibody titer results were shown in chicken group vaccinated with inactivated avian influenza virus AIV-chitosan followed by the group vaccinated with inactivated AIV-chitosan nanoparticles then the group vaccinated with oil inactivated AIV vaccine, on using chicken antigen at 2 weeks post second vaccination...
November 8, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29122439/successful-removal-of-porcine-circovirus-1-from-immunoglobulin-g-formulated-in-glycine-solution-using-nanofiltration
#11
Rong-Mei Bao, Akemi Shibuya, Takashi Uehira, Tetsuo Sato, Takeru Urayama, Kaoru Sakai, Mikihiro Yunoki
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. Therefore, in this study, we evaluate various conditions for process solutions during nanofiltration using PCV1...
November 6, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29100669/current-status-and-future-prospective-of-vaccine-development-against-echinococcus-granulosus
#12
REVIEW
Mohammad Mostafa Pourseif, Gholamali Moghaddam, Nazli Saeedi, Abolfazl Barzegari, Jaber Dehghani, Yadollah Omidi
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. granulosus life cycle may be the key to the production of powerful vaccines. Some progress has been accomplished in the development of vaccines against hydatidosis using empirical approaches, while such immunotherapies often fail to induce adequate immune responses...
October 31, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29111376/analysis-of-the-proficiency-of-single-radial-immunodiffusion-assays-for-quality-control-of-influenza-vaccines-in-korea
#13
Yejin Choi, Sunmi Lee, Seong Yi Kwon, Younghee Lee, Yong Keun Park, Sang Ja Ban
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. Eight laboratories participated in this study, and the proficiencies of all laboratories yielded satisfactory results in overall SRID assays...
October 27, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29111375/a-novel-protocol-to-provide-a-suitable-cardiac-model-from-induced-pluripotent-stem-cells
#14
Mahsa Rasekhi, Masoud Soleimani, Behnaz Bakhshandeh, Majid Sadeghizadeh
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...
October 27, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29107446/characterisation-of-the-site-specific-monopegylated-rhg-csf-analogue-pegteograstim
#15
Jeungwoon Hong, Byoungju Lee, Kwanyub Kang, Seung-Hoon Lee, Jaehwan Ryu, Gangsoo Jung, Jaetaek Oh, Eui-Cheol Jo, Chan-Wha Kim
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...
October 26, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28870397/eradicating-hepatitis-b-virus-the-critical-role-of-preventing-perinatal-transmission
#16
REVIEW
Cladd E Stevens, Pearl Toy, Saleem Kamili, Patricia E Taylor, Myron J Tong, Guo-Liang Xia, Girish N Vyas
Prevention of hepatitis B virus (HBV) transmission from infected mothers to their newborns is critical to HBV control and eventual eradication. Mother-to-child perinatal transmission causes the highest chronic carrier rate (>85%) with a high rate of subsequent chronic liver disease and hepatocellular carcinoma. This risk is reduced by 90% with HBV vaccine given along with hepatitis B immune globulin (HBIG) starting at birth. New analyses of our data from US trials of HBIG and HBV vaccine in high-risk infants revealed better efficacy with yeast-recombinant vaccine than plasma-derived vaccine, especially in preventing late onset infections, with evidence that vaccine prevented transmission of maternal HBV infection with the glycine to arginine mutation in surface antigen codon 145 (sG145R)...
November 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/29029807/binding-and-neutralizing-anti-cytomegalovirus-activities-in-immune-globulin-products
#17
Xiao Wang, Yanqun Xu, Dorothy E Scott, Haruhiko Murata, Evi B Struble
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...
October 10, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28988621/oxidation-of-m252-but-not-m428-in-hu-igg1-is-responsible-for-decreased-binding-to-and-activation-of-hu-fc%C3%AE-riia-his131
#18
Florian Cymer, Marco Thomann, Harald Wegele, Cecile Avenal, Tilman Schlothauer, Daniel Gygax, Hermann Beck
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). Recently, it has been demonstrated that binding to FcγRIIa (H131) is affected by methionine oxidation of the Fc-portion but it is currently unknown which methionine is responsible for decreased binding. We separated an oxidized IgG1 monoclonal antibody based on the oxidation state of methionine 252 and analyzed fractionated material in receptor binding experiments as well as in functional (cell-based) assays...
October 4, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28965821/biophysical-characterization-and-structure-of-the-fab-fragment-from-the-nist-reference-antibody-rm-8671
#19
Ioannis Karageorgos, Elyssia S Gallagher, Connor Galvin, D Travis Gallagher, Jeffrey W Hudgens
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. We describe preparation, characterization, and crystal structure of the Fab fragment prepared from the NIST Reference Antibody RM 8671 (NISTmAb). NISTmAb is a humanized IgG1κ antibody, produced in murine cell culture and purified by standard biopharmaceutical production methods, developed at the National Institute of Standards and Technology (NIST) to serve as a reference material...
September 28, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28958787/evaluation-of-the-combined-effects-of-pegylation-and-glycosylation-on-the-stability-of-erythropoietin-using-a-stability-indicating-se-hplc
#20
Heba S Abed, Medhat A Al-Ghobashy, Faten A Fathalla, Maissa Y Salem
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. The combined effects of pegylation and glycosylation on the stability of Peg-G-EPO was studied. Determination of Peg-G-EPO in the presence of its degradation products was achieved using SE-HPLC. The assay was validated according to ICH guidelines over concentration range of 50...
September 25, 2017: Biologicals: Journal of the International Association of Biological Standardization
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