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Biologicals: Journal of the International Association of Biological Standardization

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https://www.readbyqxmd.com/read/28774790/recovery-and-assessment-of-leukocytes-from-lr-express-filters
#1
Abby K Wegehaupt, Ellen K Roufs, Cory R Hewitt, Marisela L Killian, Oxana Gorbatenko, Cynthia M Anderson, M Scott Killian
Leukocytes, or white blood cells, are used for a variety of investigational purposes and they offer advantages over laboratory-adapted cell lines. Leukocytes that are typically discarded by blood banks during the collection of red blood cells, platelets, and plasma can often be obtained for research use. However, the available leukocytes are frequently contained within a blood filtration device, such as the Terumo LR Express (TLRE) filter. In this study, procedures were evaluated for the ability to elute viable leukocytes from TLRE filters...
July 31, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28760675/alkaline-hydrolysis-to-increase-the-selectivity-of-colorimetric-determination-of-polysorbate
#2
Andrea Engelmaier, Heinz Anderle, Alfred Weber
Here, we describe a straightforward sample pretreatment step for the colorimetric cobaltthiocyanate determination of polysorbate, which circumvents the assay's shortcomings due to interference of protein and does not require complex instrumentation. Protein-containing test samples are hydrolyzed with strong alkali at 100 °C, neutralized and clarified by filtration before applying the colorimetric assay. The modified method performs with appropriate accuracy and precision, allowing specific polysorbate measurement in the presence of Triton X-100 during virus inactivation, determination of residual amounts of polysorbate in the final products and measurement of polysorbate 80 in final formulated products...
July 28, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28754514/comparative-efficacy-of-chemical-stabilizers-on-the-thermostabilization-of-a-novel-live-attenuated-buffalopox-vaccine
#3
M S Siva Sankar, V Bhanuprakash, G Venkatesan, D P Bora, M Prabhu, R Yogisharadhya
In the present investigation, the thermostability of a live attenuated buffalopox vaccine prepared with an indigenous baffalopox virus isolate (BPXV Vij/96) and freeze-dried under conventional lyophilizing conditions is described. Three different stabilizer combinations like LS (lactalbumin hydralysate + sucrose), LHT (lactalbumin hydralysate + Trehalose dihydrate) and TAA (Trehalose dihydrate + l- Alanine + l-Histidine) were used to prepare the vaccine. The study indicated that the LS stabilizer was found to be the stabilizer of choice followed by LHT and TAA for buffalopox vaccine at all temperatures studied...
July 25, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28751059/schmallenberg-virus-an-emerging-viral-pathogen-of-cattle-and-sheep-and-a-potential-contaminant-of-raw-materials-is-detectable-by-classical-in-vitro-adventitious-virus-assays
#4
Anne Ilchmann, Alison A Armstrong, Reginald F Clayton
Emerging viruses, as potential contaminants of raw materials used in the manufacture of biologicals represent a challenge in the safety testing of biopharmaceutical products intended for human or veterinary use. Here, we report the challenge of an in vitro adventitious virus platform used in safety testing of biologicals, where a broad panel of detector cell lines was challenged to provide evidence that Schmallenberg virus is detectable by a classical reporting endpoint of cytopathic effect with Vero, BHK-21 and CHO-K1 detector cells, within typical in vitro assay timescales...
July 24, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28743417/determination-of-acceptance-criteria-and-sample-sizes-for-accelerated-stability-comparability-studies-for-biologics
#5
Binbing Yu, Lingmin Zeng, Harry Yang
Changes of manufacturing processes are common. It is required by the regulatory agencies that manufacturers establish adequate and appropriate comparability between pre-change and post-change products. The goals of comparability assessments are to demonstrate the comparability and consistency of product quality before and after change and to demonstrate that the changes do not have an adverse effect on safety and efficacy of the drug products. Accelerated or stressed stability studies may shed light on drug quality under stressed environmental conditions and on product differences in the degradation pathways...
July 22, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28734743/adjuvantation-of-inactivated-foot-and-mouth-disease-virus-vaccine-with-il-15-expressing-plasmid-improves-the-immune-response-in-guinea-pigs
#6
Vijay Nagaraj, Lijo John, Singaram Bharatiraja, Hosur Joyappa Dechamma, Golla Ramalinga Reddy
Foot and mouth disease is a highly contagious disease affecting cloven footed animals. Vaccination using inactivated virus is followed to control the disease. As the immune response conferred by the inactivated vaccine is short lived, there is a need for an alternate vaccine with increased duration of immunity. Inclusion of adjuvant which enhances B and T cell responses is one of the strategies to increase the duration of immune responses of the vaccine. Interleukin 15 is one such a cytokine which improves the cell mediated immune response and also involved in the maintenance of memory T and B cells...
July 19, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28734742/efficacy-of-a-nonadjuvanted-recombinant-felv-vaccine-and-two-inactivated-felv-vaccines-when-subject-to-consistent-virulent-felv-challenge-conditions
#7
Deborah A Grosenbaugh, Valérie Frances-Duvert, Shabnam Abedi, Bradley Feilmeier, Hongyu Ru, Hervé Poulet
The purpose of this study was to compare the efficacy of three FeLV vaccines, under identical conditions in a laboratory challenge model that closely mimics natural infection. Four groups of cats (n = 20 per group) were administered two doses of vaccine, 21 days apart, starting at 9-10 weeks of age (Purevax(®) FeLV, Versifel(®) FeLV, Nobivac(®) feline 2-FeLV, and a placebo). Cats were challenged 3 weeks later with a virulent, heterologous FeLV isolate. FeLV antigenemia was determined at weekly intervals from 3 to 15 weeks postchallenge...
July 19, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28716625/a-comparative-study-of-phenotypic-and-genotypic-first-and-second-line-drug-resistance-testing-of-mycobacterium-tuberculosis
#8
Fatemeh Sakhaee, Morteza Ghazanfari, Nayereh Ebrahimzadeh, Farzam Vaziri, Fatemeh Rahimi Jamnani, Mehdi Davari, Safoora Gharibzadeh, Fatemeh Hemati Mandjin, Abolfazl Fateh, Seyed Davar Siadat
This study aimed to evaluate the frequency of resistance to first- and second-line drugs using phenotypic and genotypic methods and its correlation with resistance-linked mutations in Mycobacterium tuberculosis (M. tb) isolated in Iran. Three different methods, including the indirect proportion method(PM), direct and indirect nitrate reductase assay(NRA), and direct sequencing were used to assess drug resistance. In this study, sensitivity, specificity, agreement, costs, and turnaround time of these methods were compared in 395 smear positive isolates...
July 15, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28693954/nano-encapsulation-of-chicken-immunoglobulin-igy-in-sodium-alginate-nanoparticles-in%C3%A2-vitro-characterization
#9
Mostafa Bakhshi, Firouz Ebrahimi, Shahram Nazarian, Jamil Zargan, Faeze Behzadi, Dawood Sadeghi Gariz
Controlled delivery of therapeutic agents by alginate nanoparticles became an attractive issue in the gastric organ. Some therapeutic agents such as proteins could not tolerate in severe condition in the gastrointestinal tract. In the present study, four concentrations of a specific IgY as a prophylactic agent against E. coli O157: H7 was entrapped in 0.2% w/v sodium alginate nanoparticles by ionic gelation method. Depending on the IgY concentration entrapment efficacy was 28.31-99.84%. The physicochemical and structural characteristics of free and IgY-loaded Alg NPs revealed that the individual particles exhibited a spherical shape with a diameter of 45-85 nm, and a negatively charged surface with a zeta potential value of 26-36 mV...
July 7, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28689674/determination-of-immune-status-in-dogs-against-cpv-2-by-recombinant-protein-based-latex-agglutination-test
#10
Jobin Thomas, Mithilesh Singh, T K Goswami, Philma Glora, Soumendu Chakravarti, Vishal Chander, Vikramaditya Upmanyu, Suman Verma, Chhavi Sharma, K Mahendran
Canine parvoviral enteritis is a highly contagious viral illness caused by canine parvovirus-2 (CPV-2) which affects puppies of mainly 6-20 weeks of age. Vaccination is pivotal in preventing and controlling CPV-2 infection. Determination of antibody status is a critical determinant for successful vaccination. The hemagglutination inhibition (HI) test is 'gold standard' test for quantification of antibodies specific to CPV-2, although the execution of this test is not feasible under field conditions. The present study was undertaken to develop a point of care testing to determine immune status prior to CPV-2 vaccination or to detect seroconversion in immunized dogs by latex agglutination test (LAT) using recombinant antigen...
July 6, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28688778/production-of-a-broad-specificity-monoclonal-antibody-and-application-as-a-receptor-to-detection-amatoxins-in-mushroom
#11
Kuo He, Qingwen Mao, Xiuyuan Zang, Yanyu Zhang, Hui Li, Donghao Zhang
In this study, we report the production of a monoclonal broad-specificity monoclonal antibody (mAb) specific for amatoxins and development of an indirect competitive immunoassay for detection of amatoxins in mushroom samples. In the assay, the complete antigen (α-amanitin-OVA) was used as coating antigen, and amatoxins as competitor competes with coating antigen to bind with mAb. Using this approach, The half-maximum inhibition concentrations (IC50) of α-amanitin, β-amanitin and γ-amanitin, and limits of detection (LODs, IC15) were 66...
July 5, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28666719/stem-cells-from-human-exfoliated-deciduous-teeth-reduce-tissue-infiltrating-inflammatory-cells-improving-clinical-signs-in-experimental-autoimmune-encephalomyelitis
#12
Cristiano Rossato, Wesley N Brandão, Sandra B R Castro, Danilo C de Almeida, Carlos M C Maranduba, Niels O S Camara, Jean P S Peron, Fernando S Silva
Stem cells from human exfoliated deciduous teeth (SHED) have great therapeutic potential and here, by the first time, we evaluated their immunomodulatory effect on experimental model of autoimmune encephalomyelitis (EAE). Specifically, we investigated the effect of SHED administration on clinical signs and cellular patterns in EAE model using Foxp3 GFP + transgenic mice (C57Bl/6-Foxp3GFP). The results showed that SHED infusion ameliorated EAE clinical score with reduced number of infiltrating IFN-γ(+)CD8(+), IL-4(+)CD8(+), IFN-γ(+)CD4(+) and IL-4(+)CD4(+) T cells into the central nervous system (CNS)...
June 27, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28666718/performance-of-microbiological-serological-molecular-and-modified-seminal-plasma-methods-in-the-diagnosis-of-brucella-abortus-in-semen-and-serum-of-bovine-bulls
#13
G Nardi Júnior, J Megid, L A Mathias, L Paulin, A F Vicente, A Cortez, F J P Listoni, G H B Lara, R G Motta, M G M Chacur, F M Monteiro, M G Ribeiro
Brucellosis remains as a major infectious disease of domestic animals and is considered a re-emerging zoonosis in several countries. B. abortus infections in bulls are related to reproductive tract infections, although infected animals show transient serological titers or nonreactor status. Thus, diagnosis of bovine brucellosis based exclusively on serological tests probably underestimates B. abortus infections in bulls. In this scenario, three hundred thirty-five serum samples from reproductively mature bovine bulls were subjected simultaneously to standard serodiagnosis using the rose Bengal test (RBT), 2-mercaptoethanol (2-ME), complement fixation (CFT), and fluorescence polarization assay (FPA)...
June 27, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28666717/drivers-and-barriers-in-the-consistency-approach-for-vaccine-batch-release-testing-report-of-an-international-workshop
#14
Martijn W P Bruysters, Marie-Jeanne Schiffelers, Marieke Hoonakker, Carmen Jungbaeck, Ian Ragan, Eddy Rommel, Ton van der Stappen, Laura Viviani, Ellen V Hessel, Arnoud M Akkermans, Rob J Vandebriel
Safety and potency assessment for batch release testing of established vaccines still relies partly on animal tests. An important avenue to move to batch release without animal testing is the consistency approach. This approach is based on thorough characterization of the vaccine, and the principle that the quality of subsequent batches is the consequence of the application of consistent production of batches monitored by a GMP quality system. Efforts to implement the consistency approach are supported by several drivers from industry, government, and research, but there are also several barriers that must be overcome...
June 27, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28645721/comparison-of-different-inactivation-methods-on-the-stability-of-indian-vaccine-strains-of-foot-and-mouth-disease-virus
#15
Arunava Sarkar, Ramasamy Periyasamy Tamil Selvan, Subodh Kishore, Kondabattula Ganesh, Veerakyathappa Bhanuprakash
In this study, the efficiency of binary ethyleneimine (BEI) in combination with formaldehyde (FA) and glutaraldehyde (GTA) in inactivating the Indian FMDV vaccine strains is compared. The acceptable safety of virus inactivation was faster and the inactivation rates were increased many-folds with combination of inactivants than BEI alone. FMDV A was inactivated rapidly than the other two serotypes with BEI + FA combination. Inactivation plots were linear for all the serotypes irrespective of inactivation process...
June 20, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28633975/efficacy-of-inactivation-of-viral-contaminants-in-hyperimmune-horse-plasma-against-botulinum-toxin-by-low-ph-alone-and-combined-with-pepsin-digestion
#16
Amram Torgeman, Nurit Mador, Marina Dorozko, Aliza Lifshitz, Naomi Eschar, Moshe D White, Dana G Wolf, Eyal Epstein
Assuring viral safety of horse plasma-derived products is fundamental for ethical and regulatory reasons. We previously demonstrated the ability of pepsin digestion at low pH to inactivate West Nile and Sindbis viruses in horse plasma. The present study further examined the efficiency of pepsin digestion to inactivate four additional viruses: HSV-1 and BVDV (lipid-enveloped), BPV and Reo-3 (nonenveloped). These viruses were spiked into hyperimmunized horse plasma against botulinum toxin and subjected to low pH (3...
June 17, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28619479/a-demonstration-of-analytical-similarity-comparing-a-proposed-biosimilar-pegfilgrastim-and-reference-pegfilgrastim
#17
Stephen Brokx, Louise Scrocchi, Nirmesh Shah, Jason Dowd
BACKGROUND: Recombinant human granulocyte-colony stimulating factor (G-CSF, filgrastim) is used primarily to reduce incidence and duration of severe neutropenia and its associated complications in cancer patients that have received a chemotherapy regimen. The pegylated form of filgrastim, "pegfilgrastim", is a long-acting form that requires only a once-per-cycle administration for the management of chemotherapy-induced neutropenia. Apobiologix, a division of ApoPharma USA, Inc., and Intas Pharmaceuticals Limited have co-developed a proposed pegfilgrastim biosimilar to US-licensed pegfilgrastim...
June 12, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28602577/fabrication-of-porous-scaffolds-with-decellularized-cartilage-matrix-for-tissue-engineering-application
#18
Bita Nasiri, Shohreh Mashayekhan
Due to the avascular nature of articular cartilage, damaged tissue has little capacity for spontaneous healing. Three-dimensional scaffolds have potential for use in tissue engineering approach for cartilage repair. In this study, bovine cartilage tissue was decellularized and chemically crosslinked hybrid chitosan/extracellular matrix (ECM) scaffolds were fabricated with different ECM weight ratios by simple freeze drying method. Various properties of chitosan/ECM scaffolds such as microstructure, mechanical strength, swelling ratio, and biodegradability rate were investigated to confirm improved structural and biological characteristics of chitosan scaffolds in the presence of ECM...
June 8, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28596049/modern-science-for-better-quality-control-of-medicinal-products-towards-global-harmonization-of-3rs-in-biologicals-the-report-of-an-epaa-workshop
#19
Katrin Schutte, Anna Szczepanska, Marlies Halder, Klaus Cussler, Ursula G Sauer, Catrina Stirling, Sylvie Uhlrich, Iwona Wilk-Zasadna, David John, Martin Bopst, Joerg Garbe, Harrie L Glansbeek, Robin Levis, Pieter-Jan Serreyn, Dean Smith, Paul Stickings
This article summarizes the outcome of an international workshop organized by the European Partnership for Alternative Approaches to Animal Testing (EPAA) on Modern science for better quality control of medicinal products: Towards global harmonization of 3Rs in biologicals. As regards the safety testing of biologicals, the workshop participants agreed to actively encourage the deletion of abnormal toxicity tests and target animal batch safety tests from all relevant legal requirements and guidance documents (country-specific guidelines, pharmacopoeia monographs, WHO recommendations)...
June 5, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28596048/impact-of-antigens-adjuvants-and-strains-on-sexually-dimorphic-antibody-response-to-vaccines-in-mice
#20
Xin Li, Sheng Guo, Lei Yang, Li Hua, Zhiqin Li, Xu Hao, Yongli Yu, Wei Sun, Liying Wang
Sexually dimorphic antibody response to vaccines has long been noticed. In addition to sex hormones, other factors such as antigens, adjuvants and strains of mice, as shown by indirect evidence, could also impact the sexual dimorphism. To clarify this, we immunized both gender mice of distinct strains with inactivated FMDV or HBsAg with or without adjuvants, and detected the specific antibody response of the mice. We found that in absence of adjuvants, the recombinant HBsAg but not the inactivated FMDV induced enhanced IgG antibody response in the female BALB/c mice...
June 5, 2017: Biologicals: Journal of the International Association of Biological Standardization
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