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Biologicals: Journal of the International Association of Biological Standardization

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https://www.readbyqxmd.com/read/28888427/scientific-considerations-for-the-regulatory-evaluation-of-cell-therapy-products
#1
REVIEW
John Petricciani, Takao Hayakawa, Glyn Stacey, Jean-Hugues Trouvin, Ivana Knezevic
Cell therapy involves the administration of a viable somatic cell preparation to a patient for the treatment of a disease or traumatic damage. Because cell therapies are complex and very different from traditional biological products, they present significant challenges for regulatory authorities, manufacturers, developers, health care providers, and patients involved in their application. Like other emerging areas of biomedical research and development, there are many issues where regulatory views and decisions among countries and regions may differ due to minimal scientific evidence to support safety and efficacy, and lack of experience with these novel treatments...
September 6, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28882403/biochemical-comparison-of-four-commercially-available-human-%C3%AE-1-proteinase-inhibitors-for-treatment-of-%C3%AE-1-antitrypsin-deficiency
#2
David J Boerema, Bo An, Ronak P Gandhi, Randy Papineau, Ed Regnier, Anna Wilder, Alexander Molitor, Andrew P Tang, Scott M Kee
Intravenous therapy with purified plasma-derived alpha1-proteinase inhibitor (α1-PI) concentrates is the only specific treatment for α1-PI deficiency. For the therapy to be safe and efficacious, α1-PI concentrates should be highly pure and contain high amounts of functional protein. This study compared the four plasma-derived α1-PI products commercially available in Europe (Respreeza, Prolastin, Alfalastin, Trypsone) by biochemical methods with respect to function, purity, structure, and chemical modifications...
September 4, 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
#3
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)...
September 1, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28851622/improved-stem-cell-therapy-of-spinal-cord-injury-using-gdnf-overexpressed-bone-marrow-stem-cells-in-a-rat-model
#4
Mostafa Shahrezaie, Reyhaneh Nassiri Mansour, Bahare Nazari, Hadi Hassannia, Fatemeh Hosseini, Hossein Mahboudi, Mohamad Eftekhary, Mousa Kehtari, Arash Veshkini, Abbas Ahmadi Vasmehjani, Seyed Ehsan Enderami
The use of stem cell base therapy as an effective strategy for the treatment of spinal cord injury (SCI) is very promising. Although some strategy has been made to generate neural-like cells using bone marrow mesenchymal stem cells (BMSCs), the differentiation strategies are still inefficiently. For this purpose, we improved the therapeutic outcome with utilize both of N-neurotrophic factor derived Gelial cells (GDNF) gene and differentiation medium that induce the BMSCs into the neural-like cells. The differentiated GDNF overexpressed BMSCs (BMSCs-GDNF) were injected on the third day of post-SCI...
August 26, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28844541/a-phase-1-study-to-evaluate-the-safety-and-pharmacokinetics-of-medi8852-an-anti-influenza-a-monoclonal-antibody-in-healthy-adult-volunteers
#5
Raburn M Mallory, S Omar Ali, Therese Takas, Martin Kankam, Filip Dubovsky, Leo Tseng
MEDI8852 is an IgG1 kappa monoclonal antibody that is being developed to treat patients hospitalized with influenza A. We evaluated the safety and tolerability, pharmacokinetics, and anti-drug antibodies (ADA) of a single intravenous dose of MEDI8852 in healthy adult volunteers (NCT02350751). Forty subjects were randomized to receive either MEDI8852 (250, 750, 1,500, or 3000 mg) (n = 32) or placebo (n = 8) on day 1. Dose escalation was based on cumulative safety data through day 8. Subjects were followed through day 101 for safety, pharmacokinetics, and ADA...
August 22, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28838806/evaluation-of-marker-gene-expression-as-a-potential-predictive-marker-of-leukopenic-toxicity-for-inactivated-influenza-vaccines
#6
Eita Sasaki, Haruka Momose, Yuki Hiradate, Keiko Furuhata, Mamiko Takai, Kazunari Kamachi, Hideki Asanuma, Ken J Ishii, Takuo Mizukami, Isao Hamaguchi
The leukopenic toxicity test (LTT) is used to evaluate the safety and lot-to-lot consistency of influenza hemagglutinin split vaccine (HAv) and is included in the Japanese Minimum Requirements for Biological Products. LTT assesses the reduced leukocyte levels in murine peripheral blood after HAv administration. However, they require large numbers of animals, and therefore it would be beneficial to develop a more accurate and sensitive alternative method. In this study, we selected biomarkers of leukocyte reduction from 18 previously identified marker genes that were associated with an abnormal toxicity test (ATT)...
August 21, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28826780/towards-a-peptide-based-vaccine-against-shigella-sonnei-a-subtractive-reverse-vaccinology-based-approach
#7
Shehneela Baseer, Sajjad Ahmad, Kara E Ranaghan, Syed Sikander Azam
Shigella sonnei is one of the major causes of shigellosis in technically advanced countries and reports of its unprecedented increase are published from the Middle East, Latin America, and Asia. The pathogen exhibits resistance against first and second line antibiotics which highlights the need for the development of an effective broad-spectrum vaccine. A computational based approach comprising subtractive reverse vaccinology was used for the identification of potential peptide-based vaccine candidates in the proteome of S...
August 18, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28822684/cross-reactivity-and-inhibition-myotoxic-effects-induced-by-bothrops-snake-venoms-using-specific-polyclonal-anti-bnsp7-antibodies
#8
Lamartine L Melo, Mirian M Mendes, Lívia M Alves, Thais F Isabel, Sâmela A P B Vieira, Sarah N C Gimenes, Andreimar M Soares, Veridiana M Rodrigues, Luiz F M Izidoro
Polyclonal antibodies raised in Balb-c mice against BnSP-7, a Lys-49 phospholipase A2, were used to measure cross reactivity against other snake venoms. Using ELISA, these antibodies were able to recognize PLA2s isoforms present in venoms of botropic snakes at 1:6400, 1:3200 and 1:100 ratios (w/w). These antibodies highly recognized proteins of low molecular weight (∼14,000) from crude snake venom Bp and Bm by Western Blotting. PLA2 these venoms, by alignment of primary structures demonstrated high identity with BnSP-7 PLA2, especially in the C-terminal region...
August 16, 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
#9
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
#10
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/28818424/interlaboratory-study-for-the-establishment-of-brazilian-bothrops-reference-venom-and-antivenom-for-potency-evaluation-of-bothrops-antivenom
#11
Humberto Pinheiro de Araújo, Elizabeth Porto Reis Lucas, Wlamir Corrêa de Moura, Celia de Fátima Barbosa, Raquel Joane Rodrigues, Josefina Farina Morais, Joseana Zaja Almada, Barbara Carino Guimarães, Antonio Eugenio Castro Cardoso de Almeida, Maria Aparecida Affonso Boller
A collaborative study was performed for the establishment of the 5th lot of Brazilian Bothrops Reference Venom and the 1st lot of Brazilian Bothrops Reference Antivenom. All Brazilian manufacturers of Antibothrops Immunoglobulins and the National Control Laboratory participated of the study. The declared potency of the 5th lot of the Bothrops Reference Venom is 40.29 μg/0.5 ml, and the potency of the 1st lot of Bothrops Reference Antivenom is 6.51 mg/ml. For the potency evaluation of Bothrops Reference Venom the inter assay precision (gCV) was 3...
September 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28818423/design-and-synthesis-of-multiple-antigenic-peptides-and-their-application-for-dengue-diagnosis
#12
Reeta Rai, Sameer Dubey, K V Santosh, Ashutosh Biswas, Vinit Mehrotra, D N Rao
Major difficulty in development of dengue diagnostics is availability of suitable antigens. To overcome this, we made an attempt to develop a peptide based diagnosis which offers significant advantage over other methods. With the help of in silico methods, two epitopes were selected from envelope protein and three from NS1 protein of dengue virus. These were synthesized in combination as three multiple antigenic peptides (MAPs). We have tested 157 dengue positive sera confirmed for NS1 antigen. MAP1 showed 96...
September 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28774790/recovery-and-assessment-of-leukocytes-from-lr-express-filters
#13
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...
September 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
#14
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...
September 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
#15
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...
September 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
#16
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...
September 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
#17
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...
September 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
#18
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...
September 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
#19
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...
September 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
#20
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...
September 2017: Biologicals: Journal of the International Association of Biological Standardization
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