Use of NMR as an analytical tool in the process development of conjugate vaccines against Haemophilus influenzae type b (Hib) and meningococcal serogroup A (MenA)
Publication date: Available online 20 October 2019Source: BiologicalsAuthor(s): Suresh Beri, Darshan Gandhi, Neil RavenscroftAbstractThe native structure of the bacterial polysaccharide is the key immunogenic component of conjugate vaccines and antibodies raised against the polysaccharide structure are responsible for providing protection against the corresponding pathogen. The manufacturing process of conjugate vaccines is very complex and has various biological and chemical steps. It is important to monitor the process to ensure that the structural identity of the polysaccharide is maintained throughout the process. NMR ...
Source: Biologicals - October 22, 2019 Category: Biology Source Type: research

In vitro differentiation of conjunctiva mesenchymal stem cells into insulin producing cells on natural and synthetic electrospun scaffolds
In this study the differentiation capability of conjunctiva mesenchymal stem cells (CJMSCs) on natural and synthetic nanofibrous electrospun scaffolds into insulin producing cells (IPCs) were studied.Natural Silk fibroin and synthetic PLLA polymers were used to fabricate electrospun scaffolds. These scaffolds are characterized by SEM and CJMSCs were differentiated into IPCs on these scaffolds. The differentiation efficiency was measured by analysis the expression of specific pancreatic markers by RT-qPCR and insulin release capacity via ELISA.Microscopy analysis showed the fabrication of uniform nanofibers and the formatio...
Source: Biologicals - October 19, 2019 Category: Biology Source Type: research

Evaluation of immunogenicity and protective effect of DNA vaccine encoding surface antigen1 (SAG1) of Toxoplasma gondii and TLR-5 ligand as a genetic adjuvant against acute toxoplasmosis in BALB/c mice
ConclusionThis investigation indicated that cocktail DNA vaccine encoded SAG1 gene of T. gondii and FliC can protect against acute toxoplasmosis. (Source: Biologicals)
Source: Biologicals - October 13, 2019 Category: Biology Source Type: research

S.Typhi derived OmpC peptide conjugated with Vi-polysaccharide evokes better immune response than free Vi-polysaccharide in mice
Publication date: Available online 9 October 2019Source: BiologicalsAuthor(s): Shabirul Haque, Sanjukta Sengupta, Dinesh Gupta, Maharaj Kishan Bhan, Ramesh Kumar, Azhar Khan, Bansilal JailkhaniAbstractSalmonella typhi is a causative organism for typhoid fever. Free Vi capsular polysaccharide (Vi) is licensed for use as vaccine for typhoid fever in individuals 2 years of age and older, which has limited memory response. There is dire need of protein or peptide as conjugate partner with Vi polysaccharide to improve shortcomings of Vi vaccine. Prediction of immunogenic peptide was deduced by program T sites. Carbodiimide medi...
Source: Biologicals - October 10, 2019 Category: Biology Source Type: research

Considering “clonality”: A regulatory perspective on the importance of the clonal derivation of mammalian cell banks in biopharmaceutical development
Publication date: Available online 3 October 2019Source: BiologicalsAuthor(s): Joel T. Welch, N. Sarah ArdenAbstractThere has been much recent focus on the regulatory emphasis and the relative importance surrounding clonal derivation of mammalian production cell lines used in the manufacture of recombinant DNA-derived biopharmaceuticals. This interest has led to an ongoing discussion between regulators and industry on how this topic is evaluated and the role it plays in the development of a new biopharmaceutical. Herein the authors describe that the clonal derivation of the production cell line is a factor with potential i...
Source: Biologicals - October 4, 2019 Category: Biology Source Type: research

Characterization of defective interfering (DI) particles of Pestedes petitsruminants vaccine virus Sungri/96 strain-implications in vaccine upscaling
Publication date: Available online 3 October 2019Source: BiologicalsAuthor(s): Mousumi Bora, Raja Wasim Yousuf, Pronab Dhar, M. Manu, Insha Zafir, Bina Mishra, Kaushal Kishor Rajak, Rabindra Prasad SinghAbstractThe present investigation deals with the characterization of defective interfering (DI) particles of Peste-des-petits ruminants (PPR) vaccine Sungri/96 strain generated as a result of high MOI in Vero cells. During the serial 10 passages, infectivity titres drastically reduced from 6.5 to 2.25 log10TCID50/ml at high MOI. Further, attenuation of CPE with high MOI indicated generation of DI particles that resulted in ...
Source: Biologicals - October 4, 2019 Category: Biology Source Type: research

Monoclonal antibody purification and its progression to commercial scale
Publication date: Available online 23 September 2019Source: BiologicalsAuthor(s): Digamber Singh Chahar, Selvan Ravindran, S.S. PisalAbstractWith the advancements in upstream technologies, the capacity for monoclonal antibody (mAb) production has transformed from a few milligrams to grams per liter. These titers lead to enormous pressure on downstream processes (DSPs), which need to be reworked to achieve higher efficiency and better utilization of available resources. Various parameters, such as column sizing, aggregate removal, filtration and volume handling, must be considered while designing a facility for commercial s...
Source: Biologicals - September 24, 2019 Category: Biology Source Type: research

Method validation of Q-PCR detection of host residual DNA in antibody drug based on protein A magnetic beads
Publication date: Available online 18 September 2019Source: BiologicalsAuthor(s): Xiao-zhi Liu, Bin Zhang, Wei Zhao, Geng Li, Mei-ling Zhou, Jing-shuang Wei, Jing-hua Zhou, Jian Gao, Zhi-ming WangAbstractThe residual DNA derived from host cells in antibody drugs have potential safety risks. In this paper, the antibody in the test sample was removed by magnetic bead separation method, and the residual DNA were quantitatively determined by Q-PCR method. The residual DNA in the sample was analyzed according to the standard curve. We validated the species specificity, accuracy, precision, quantitative restrictions, reproducibi...
Source: Biologicals - September 19, 2019 Category: Biology Source Type: research

Collaborative study for the calibration of the replacement International Standard for pertussis toxin for use in histamine sensitisation and CHO cell clustering assays
Publication date: Available online 13 September 2019Source: BiologicalsAuthor(s): Alexandra Douglas-Bardsley, Catpagavalli Asokanathan, Sharon Tierney, Jason Hockley, Kevin MarkeyAbstractPertussis toxin (PT) in its detoxified form is one of the major protective antigens in vaccines against Bordetella pertussis (whooping cough). Reference preparations of native PT are required for the quality control of pertussis vaccines. Stocks of the first WHO International Standard (IS) for PT (JNIH-5) were low and a replacement was required. One candidate material was donated by a vaccine manufacturer to NIBSC. It was formulated, lyoph...
Source: Biologicals - September 15, 2019 Category: Biology Source Type: research

Comparison of the liquid and lyophilized formulations of Prolastin®-C for Alpha1-Antitrypsin deficiency: Biochemical characteristics, pharmacokinetics, safety and neoantigenicity in rabbits
Publication date: Available online 12 September 2019Source: BiologicalsAuthor(s): Vikram Arora, Maria Cruz, John Lang, Anthony M. Klos, W. Keither Merritt, Jeffrey Price, George Taylor, Pete Vandeberg, Kevin Wee, Todd WillisAbstractMultiple analytical and preclinical studies were performed to compare the biochemical characteristics, pharmacokinetics (PK), safety and neoantigenicity of a new 5% liquid formulation of Alpha-1 Proteinase Inhibitor (Liquid A1PI, Prolastin®-C Liquid) with the lyophilized version (Lyophilized A1PI, Prolastin®-C). Liquid A1PI and Lyophilized A1PI had similar average mass (~52 kDa), and bot...
Source: Biologicals - September 13, 2019 Category: Biology Source Type: research

Aims and Scope/Editorial Board/Publishing Details
Publication date: September 2019Source: Biologicals, Volume 61Author(s): (Source: Biologicals)
Source: Biologicals - September 12, 2019 Category: Biology Source Type: research

Tetanus antitoxin potency assessment by surface plasmon resonance and ToBI test
Publication date: Available online 11 September 2019Source: BiologicalsAuthor(s): Wagner Quintilio, Josana Kapronezai, Daniela Yumi Takata, José Roberto Marcelino, Ana Maria MoroAbstractPotency testing of tetanus antitoxin must be performed in vivo, in a very painful, stressful and prone to high variability assay. It is, therefore, mandatory to find alternatives to this kind of potency assessment. Immunochemical tests as ELISA or ToBI test are already available but usually results in a poor correlation to the in vivo protection. Considering research and development of mono and oligoclonal antibodies against tetanus ...
Source: Biologicals - September 12, 2019 Category: Biology Source Type: research

Evaluation of carboxyl beads based latex agglutination test for rapid sero-diagnosis of Japanese encephalitis
Publication date: Available online 10 September 2019Source: BiologicalsAuthor(s): M.R. Grace, Jyotsana Chauhan, M. Suman Kumar, Ashok Kumar, K.N. Bhilegaonkar, Mithilesh Singh, Himani DhanzeAbstractJapanese encephalitis (JE) is a major public health problem in the South Asian countries including India. Pigs serve as a relevant sentinel model, the surveillance of which could predict a potential JE outbreak in human population nearby. However, existing serological detection methods like Enzyme-Linked Immuno Sorbent Assay (ELISA), virus neutralization test (VNT) and Haemagglutination Inhibition (HI) require elaborative labora...
Source: Biologicals - September 10, 2019 Category: Biology Source Type: research

Metabolic and proliferation evaluation of human adipose-derived mesenchymal stromal cells (ASC) in different culture medium volumes: standardization of static culture
Publication date: Available online 6 September 2019Source: BiologicalsAuthor(s): Vinícius Augusto Simão, Caetano Pedro Evangelista-Ribeiro, Heloisa Brand, Lougan Lagass-Pereira, Laís Fernanda Marques, Pedro Henrique Benites-Aoki, Roseli Nunes da Silveira-Antunes, Aldo Tonso, João Tadeu Ribeiro-PaesAbstractAdipose-derived mesenchymal stromal/stem cells (ASC) have acquired a prominent role in tissue engineering and regenerative medicine. However, the standardization of basic culture procedures in this cellular type is still not well established according to the main qualitative cellular attributes...
Source: Biologicals - September 6, 2019 Category: Biology Source Type: research

The new China vaccine administration law: Re-establishing confidence in vaccines
Publication date: Available online 30 August 2019Source: BiologicalsAuthor(s): Baobin Huang (Source: Biologicals)
Source: Biologicals - August 31, 2019 Category: Biology Source Type: research

The duck EB66® cell substrate reveals a novel retrotransposon
Publication date: Available online 30 August 2019Source: BiologicalsAuthor(s): Fabien Perugi, Caroline Freslon-Evain, Luc Batard, Pauline Guillet, Klaus SchwambornAbstractDuring the establishment of the duck EB66® cell line as a new cell substrate for vaccine production in industry, a very low level of reverse transcriptase (RT) activity was detected in the culture supernatant by product-enhanced RT assay but a whole battery of tests failed to evidence infectious particles. Results from extensive biochemical and physical testing demonstrated that RT activity was associated to an intracellular, non-enveloped and dense s...
Source: Biologicals - August 31, 2019 Category: Biology Source Type: research

Evaluation of a capture antigen ELISA for the characterisation of tetanus vaccines for veterinary use
Publication date: Available online 27 August 2019Source: BiologicalsAuthor(s): Rebecca Riches-Duit, Laura Hassall, Peter Rigsby, Paul StickingsAbstractWe previously developed an ELISA assay for detection of tetanus toxoid antigen in tetanus vaccines for human use. Tetanus vaccines for veterinary use are qualitatively different to those used in humans, often containing a larger number and variety of non-tetanus antigens in the multi-valent products, and adjuvants that are not found in human vaccines. We assessed performance of the capture ELISA with a range of veterinary tetanus vaccines as a first step towards development ...
Source: Biologicals - August 28, 2019 Category: Biology Source Type: research

A single immunogenicity assay for testing potency of combination DTaP vaccines: Simultaneous quantitation of anti-DT, anti-TT, anti-PTxd and anti-FHA antibodies in Guinea-pig serum with a Luminex®-xMAP® bead-based serological assay
Publication date: Available online 23 August 2019Source: BiologicalsAuthor(s): Silvio Bandiera, Annabelle Lebas, Livia Canizares-Martinello, Fabien Guinchard, Corinne Lyonnais, Sophie Perrin, Marine Nicolas, Sylvie Uhlrich, Martine Chabaud-RiouAbstractThe diphtheria toxoid (DT), tetanus toxoid (TT), and acellular pertussis (aP) single immunogenicity assay (DTaP SIA) is a Luminex®-xMAP®-bead-based multiplex immunoassay for estimating the potency of DTaP pediatric combination vaccines in guinea pigs. This manuscript describes the validation of this assay for the simultaneous quantitation of anti-diphtheria toxoid (an...
Source: Biologicals - August 25, 2019 Category: Biology Source Type: research

Characterization of the viral genomes present in commercial batches of horse serum obtained by high-throughput sequencing
Publication date: Available online 23 August 2019Source: BiologicalsAuthor(s): W.P. Paim, M.N. Weber, S.P. Cibulski, M.S. da Silva, D.E. Puhl, R.F. Budaszewski, A.P.M. Varela, F.Q. Mayer, C.W. CanalAbstractHorses are often used as blood donors for commercial horse serum (HS) production and to manufacture biologicals. HS is an alternative for fetal bovine serum (FBS) used as a supplement for cell culture and vaccine production. Furthermore, HS is also frequently obtained in order to produce antisera toxins and pathogens. The advent of high-throughput sequencing (HTS) has promoted changes in virus detection, since previous k...
Source: Biologicals - August 23, 2019 Category: Biology Source Type: research

Qualification of a surface plasmon resonance assay to determine binding of IgG-type antibodies to complement component C1q
Publication date: Available online 21 August 2019Source: BiologicalsAuthor(s): Milan Jovic, Florian CymerAbstractInteraction of therapeutic antibodies with complement component C1q are frequently part of pharmaceutical characterization and production process comparability studies. Assays currently used to assess this interaction and/or the activation of the complement cascade are often cumbersome, time consuming or imprecise. We here report the further development, successful qualification and suitability evaluation of an SPR-based C1q binding assay for the characterization of IgG-C1q interactions. We evaluate different Ig...
Source: Biologicals - August 22, 2019 Category: Biology Source Type: research

Development of a novel chimeric PA-LF antigen of Bacillus anthracis, its immunological characterization and evaluation as a future vaccine candidate in mouse model
In this study, we developed a recombinant PA-LF chimera antigen of Bacillus anthracis by fusing the PA domain 2-4 with lethal factor (LF) domain 1 and evaluated its protective potential against B. anthracis in mouse model. The anti-PA-LF chimera serum reacted with both PA and LF antigen, individually. The chimera elicited a strong antibody titer in mice with predominance of IgG1 isotype followed by IgG2b, IgG2a and IgG3. Cytokines were assessed in splenocytes of immunized mice and a significant up-regulation in the expression of IL-4, IL-10, IFN-γ and TNF-α was observed. The PA-LF chimera immunized mice exhibit...
Source: Biologicals - August 14, 2019 Category: Biology Source Type: research

Development of a new 15-valent pneumococcal conjugate vaccine (PCV15) and evaluation of its immunogenicity
In this study, we propose a new PCV15 candidate, in which the common 13 serotypes and a licensed control vaccine have equivalent efficacy while two additional serotypes showed adequate immunogenicity in the rabbit model. (Source: Biologicals)
Source: Biologicals - August 14, 2019 Category: Biology Source Type: research

Diagnostics in the veterinary field: The role in health surveillance and disease identification
Publication date: Available online 13 August 2019Source: BiologicalsAuthor(s): Anja Holm, Richard Hill, Attila Farsang, Carmen JungbäckAbstractAn international workshop, held in Wiesbaden, Germany on 15–17 May 2019 provided an overview of existing and new methods and approaches to diagnostics in animal health and their benefits and challenges. The variability in quality and authority review of test kits across the world is a concern for the reliability of test results and the decisions that are based on the diagnostic data. In countries or regions without regulatory oversight, there is an urgent need for interna...
Source: Biologicals - August 14, 2019 Category: Biology Source Type: research

High-throughput LC-MS quantitation of cell culture metabolites
In this study, we present a high-throughput LC-MS method with a 17-min cycle time that is capable of simultaneously monitoring 93 cell culture metabolites, including amino acids, nucleic acids, vitamins, sugars and others. This method has high precision and accuracy and has been successfully applied to the daily profiling of bioreactors and raw material qualification. Information obtained in these studies has been used to identify limiting amino acids during production, which guided adjustments to the feed strategy that prevented the potential misincorporation of amino acids. This type of metabolite profiling can be furt...
Source: Biologicals - August 7, 2019 Category: Biology Source Type: research

Establishing China's national standards of antigen content and neutralizing antibody responses for evaluation of SFTS vaccines
Publication date: Available online 27 July 2019Source: BiologicalsAuthor(s): Yuhua Li, Zheng Jia, Xiaohong Wu, Ling Wang, Lei Chen, Xinxian Dai, Xiuling Li, Junzhi WangAbstractSevere fever with thrombocytopenia syndrome (SFTS) is an acute infectious disease caused by severe fever with thrombocytopenia syndrome virus (SFTSV). SFTS is mainly characterized by severe fever with thrombocytopenia and has a high mortality rate. The virus has been found in China, South Korea, and Japan. Effective antiviral drugs or vaccines still have been unavailable. Now, two vaccine manufacturers in China are actively engaged in the development...
Source: Biologicals - July 28, 2019 Category: Biology Source Type: research

Prescription-based prevalence of biological therapy in patients with psoriasis, rheumatoid arthritis, and inflammatory bowel diseases
This study is based on data from IMS® Diagnosis Monitor and included patients who had received a biological drug in dermatology practices due to psoriasis (PSO), gastroenterology practices due to Crohn's disease (CD) or ulcerative colitis (UC), or rheumatology practices due to rheumatoid arthritis (RA) between April 2015 and December 2018. We analyzed 1,748,948 CD/UC-related prescriptions, 3,968,879 RA-related prescriptions, and 7,321,496 PSO-related prescriptions. Of these, 343,263 (19.6%) prescriptions for IBD, 92,343 (16.2%) prescriptions for RA, and 169,573 (6.9%) prescriptions for PSO were for biologicals. The pro...
Source: Biologicals - July 19, 2019 Category: Biology Source Type: research

Aims and Scope/Editorial Board/Publishing Details
Publication date: July 2019Source: Biologicals, Volume 60Author(s): (Source: Biologicals)
Source: Biologicals - July 12, 2019 Category: Biology Source Type: research

Utility of reference materials for Zika Virus nucleic acid testing
Publication date: Available online 2 July 2019Source: BiologicalsAuthor(s): Sarah L. Kempster, Thomas Dougall, Clare Morris, Gabriel Gonzalez-Escobar, Neil Almond, Rob AndersonAbstractThe emergence of Zika virus (ZIKV) in the Americas has resulted in increased nucleic acid amplification testing (NAT) of clinical samples and blood donations. New molecular diagnostic assays have been developed resulting in a corollary requirement for ZIKV reference material. To address this we have produced and calibrated two African lineage ZIKV reference materials: a highly concentrated secondary standard (NIBSC: 16/110) and a lower concen...
Source: Biologicals - July 3, 2019 Category: Biology Source Type: research

Trabecular meshwork mesenchymal stem cell transplantation improve motor symptoms of parkinsonian rat model
Publication date: Available online 29 June 2019Source: BiologicalsAuthor(s): Hossein Mostafavi, Leila Ghassemifard, Ali Rostami, Mohsen Alipour, Samad NadriAbstractStem cell transplantation is a new therapeutic strategy in the treatment of neurodegenerative disorders such as Parkinson's disease (PD). Therefore, in this study, the therapeutic effects of Trabecular Meshwork Mesenchymal Stem Cells (TM-MSCs) transplantation, as a new source of mesenchymal stem cells, were evaluated in the animal model of PD.After the development and confirmation of hemi-parkinsonian rats by administration of 6-hydroxy dopamine (6-OHDA) and apo...
Source: Biologicals - June 30, 2019 Category: Biology Source Type: research

Achieving scientific and regulatory success in implementing non-animal approaches to human and veterinary rabies vaccine testing: A NICEATM and IABS workshop report
Publication date: Available online 27 June 2019Source: BiologicalsAuthor(s): Rebecca Poston, Richard Hill, Cynthia Allen, Warren Casey, Donna Gatewood, Robin Levis, Laurent Mallet, Dean Smith, Geetha Srinivas, Catrina Stirling, David AllenAbstractThis two-day workshop, co-sponsored by NICEATM and IABS-NA, brought together over 60 international scientists from government, academia, and industry to advance alternative methods for human and veterinary Rabies Virus Vaccine (RVV) potency testing. On day one, workshop presentations focused on regulatory perspectives related to in vitro potency testing, including recent additions...
Source: Biologicals - June 27, 2019 Category: Biology Source Type: research

Self-reported satisfaction of patients receiving omalizumab for severe allergic asthma in Malta
Publication date: Available online 18 June 2019Source: BiologicalsAuthor(s): Caroline Gouder, Simon Gouder, Stephen MontefortAbstractTreatment satisfaction is of utmost importance for ensuring adherence. Omalizumab is administered long-term if effective and well-tolerated in a hospital setting. The aim was to evaluate treatment satisfaction with omalizumab in Malta and to identify factors that may influence patients’ satisfaction.A questionnaire was distributed to all asthmatic adult patients receiving omalizumab for at least one year. The questionnaire included demographic data, dosing regimen, asthma control test a...
Source: Biologicals - June 19, 2019 Category: Biology Source Type: research

Generation of acid resistant virus like particles of vaccine strains of foot-and-mouth disease virus (FMDV)
Publication date: Available online 17 June 2019Source: BiologicalsAuthor(s): P.R. Deepak, P. Saravanan, J.K. Biswal, S.H. Basagoudanavar, H.J. Dechamma, V. Umapathi, B.P. Sreenivasa, R.P. Tamilselvan, N. Krishnaswamy, I. Zaffer, A. SanyalAbstractFoot-and-mouth disease (FMD) is a contagious viral disease affecting cloven hoofed livestock. Insect cell expressed virus like particles (VLPs) are potential alternative to overcome the limitations of inactivated vaccine. However, at pH
Source: Biologicals - June 18, 2019 Category: Biology Source Type: research

Combining secukinumab and fingolimod to successfully treat ankylosing spondylitis and multiple sclerosis – A novel approach
Publication date: Available online 13 June 2019Source: BiologicalsAuthor(s): Muhammad K. Nisar (Source: Biologicals)
Source: Biologicals - June 14, 2019 Category: Biology Source Type: research

Generic immune complex assay for detection of murine anti-drug-antibodies in complex with human IgG
Publication date: Available online 11 June 2019Source: BiologicalsAuthor(s): Lykke Boysen, Anne M.E. Sprinkel, Brian Lauritzen, Jens Breinholt, Jens Lykkesfeldt, Birgitte M. Viuff, Lone H. LandsyAbstractRapid and versatile methods are needed for evaluation of immunogenicity in early safety studies. The present work presents a generic, simple and easy to use sandwich enzyme-linked immunosorbent assay for quasi-quantitative measurement of circulating immune complexes (CICs) formed by anti-drug antibodies (ADAs) in complex with human IgG in mouse plasma. The assay is suitable for evaluating the presence of in vivo formed CICs...
Source: Biologicals - June 12, 2019 Category: Biology Source Type: research

Evaluation of environment safety of a Japanese encephalitis live attenuated vaccine
Publication date: Available online 7 June 2019Source: BiologicalsAuthor(s): Xinyu Liu, Lili Jia, Kaixiao Nie, Danhua Zhao, Rui Na, Hongshan Xu, Gong Cheng, Junzhi Wang, Yongxin Yu, Yuhua LiAbstractJE vaccination is the most effective and economical method of preventing JE. A live attenuated JE vaccine has been widely used in many countries since 1989, playing an important role in controlling JE outbreaks. However, whether the large-scale use of the live attenuated JE vaccine will lead to the dissemination of the vaccine virus in the environment and whether reversion of the neuroattenuation of the virus will occur during th...
Source: Biologicals - June 8, 2019 Category: Biology Source Type: research

Octanorm [cutaquig®], a new immunoglobulin (human) subcutaneous 16.5% solution for injection (165 mg/mL) – Biochemical characterization, pathogen safety, and stability
Publication date: Available online 1 June 2019Source: BiologicalsAuthor(s): Nicola Gelbmann, Alfred Zöchling, Alexander Pichotta, Torben Schmidt, Andrej Murányi, Thomas Ernegger, Katharina Pock, Jürgen RömischAbstractOctanorm (marketed as cutaquig® in Canada and US [2018] and registered in several European countries [2019]) is a new immunoglobulin subcutaneous 16.5% liquid for the treatment of patients with primary immune deficiency (PID) and secondary immune deficiency (SID) depending on country's specific indications.Octanorm contains ≥96% human IgG and is characterized by especially low conc...
Source: Biologicals - June 2, 2019 Category: Biology Source Type: research

The INN global nomenclature of biological medicines: A continuous challenge
Publication date: Available online 23 May 2019Source: BiologicalsAuthor(s): James S. Robertson, Wai-Keung Chui, Armando A. Genazzani, Sarel F. Malan, Ana López de la Rica Manjavacas, Gilles Mignot, Robin Thorpe, Raffaella Balocco, Menico RizziAbstractMedicines are assigned International Nonproprietary Names (INN) by the World Health Organization (WHO), pursuing the aim to increase patient safety. Following scientific developments in drug discovery and biotechnology, the number of biological medicines is constantly growing and a surge in INN applications for them has been observed. Pharmacologically active biological...
Source: Biologicals - May 24, 2019 Category: Biology Source Type: research

Meeting report narcolepsy and pandemic influenza vaccination: What we know and what we need to know before the next pandemic? A report from the 2nd IABS meeting
Publication date: Available online 23 May 2019Source: BiologicalsAuthor(s): Kathryn Edwards, Germaine Hanquet, Steve Black, Emmanuel Mignot, Christopher Jankosky, Tom Shimabukuro, Elizabeth Miller, Hanna Nohynek, Pieter NeelsAbstractA group of scientific and public health experts and key stakeholders convened to discuss the state of knowledge on the relationship between adjuvanted monovalent inactivated 2009 influenza A H1N1 vaccines used during the 2009 influenza pandemic and narcolepsy. There was consensus that an increased risk of narcolepsy was consistently observed after Pandemrix (AS03-adjuvanted) vaccine, but simila...
Source: Biologicals - May 24, 2019 Category: Biology Source Type: research

Quantitation of residual sodium dodecyl sulfate in meningococcal polysaccharide by gas chromatography-mass spectrometry
Publication date: Available online 22 May 2019Source: BiologicalsAuthor(s): Niraj Shende, Abhijeet Karale, Preeti Marathe, Sourish Chakraborty, Asha D. Mallya, Rajeev M. DhereAbstractSodium dodecyl sulfate (SDS) is a commonly used surfactant in protein solubilization and also during the polysaccharide purification. A GC-MS method has been developed to quantitate residual SDS in meningococcal polysaccharide serogroups A,C,W,Y and X circumventing the need of spectroscopic assays and HPLC based methods which are either unstable or requires the confirmation by MS. The developed method is based on quantitative conversion of SDS...
Source: Biologicals - May 22, 2019 Category: Biology Source Type: research

Choice of parvovirus model for validation studies influences the interpretation of the effectiveness of a virus filtration step
Publication date: Available online 16 May 2019Source: BiologicalsAuthor(s): Thomas Nowak, Birgit Popp, Nathan J. RothAbstractDifferent parvoviruses are used interchangeably as models in validation studies to demonstrate effective clearance of small viruses by filtration in the manufacturing of biotherapeutics.The aim of these experiments was to determine if filtration of different parvoviruses (canine parvovirus [CPV], minute virus of mice [MVM], and porcine parvovirus [PPV]) results in similar virus retention.While filtration with a Planova™ 20 N filter (mean pore size: 19 ± 2 nm) completely removed P...
Source: Biologicals - May 18, 2019 Category: Biology Source Type: research

The development and establishment of the 1st WHO BKV International Standard for nucleic acid based techniques
We report on the evaluation of two lyophilised candidate cell culture derived, whole virus preparations, undertaken by 33 expert laboratories. By employing the principles of biological standardisation, we show improved agreement across laboratories, demonstrating the suitability of either candidate for use as a primary order calibrant. Candidate 14/212 was established by the WHO ECBS with an assigned potency of 7.2 log10 International Units/mL intended for the calibration of BKV secondary reference materials. (Source: Biologicals)
Source: Biologicals - May 18, 2019 Category: Biology Source Type: research

Potency test to discriminate between differentially over-inactivated rabies vaccines: Agreement between the NIH assay and a G-protein based ELISA
In this study we have generated several non-conform vaccine lots by an excessive inactivation with β-propiolactone (BPL) and assessed the capacity of both tests to detect the corresponding consequences. Excessive BPL inactivation causes G-protein unfolding, altering in turn viral morphology and the continuity of the G-protein layer in the viral particle. Both the NIH and the ELISA tests were able to monitor the consequences of excessive inactivation in a similar manner. Of note, the experimental error of the ELISA test was well below that of the NIH test. These results increase the prospect that the ELISA test could b...
Source: Biologicals - May 18, 2019 Category: Biology Source Type: research

Cloning and expression of a novel synthetic gene containing VP1 and 3A in Bacillus subtilis as a vaccine candidate against foot-and-mouth disease virus
In this study the bioinformatics characteristics of VP1 [141–160 and 23–42] and 3A [21–35] of Iranian serotypes O, A and Asia 1 was obtained using on-line predicting software. Then the sequence VP1 [141–160]-GS-VP1 [23–42]-GS-3A [21–35]-GS were codon-optimized and cloned onpHT43shuttle vector and finally expressed in Bacillus subtilis WB600 strain. We could predict VP1 [141–160] as a B cell epitope, VP1 [23–42] as a CTL epitope and 3A [21–35] as a Th cell epitope. The 20KD recombinant protein expressed by Bacillus subtilis were detected by SDS-PAGE. The results showed t...
Source: Biologicals - May 16, 2019 Category: Biology Source Type: research

Aims and Scope/Editorial Board/Publishing Details
Publication date: May 2019Source: Biologicals, Volume 59Author(s): (Source: Biologicals)
Source: Biologicals - May 16, 2019 Category: Biology Source Type: research

A strategic road map to filing a Biologics License Application for a pluripotent stem cell derived therapeutic product
Publication date: Available online 30 April 2019Source: BiologicalsAuthor(s): Abla A. Creasey, Glyn Stacey, Kapil Bharti, Yoji Sato, Anthony Lubiniecki (Source: Biologicals)
Source: Biologicals - May 1, 2019 Category: Biology Source Type: research

Immunoglobulin G from single plasma donor in immune globulin intravenous causes false positive pyrogen test
Publication date: Available online 22 April 2019Source: BiologicalsAuthor(s): Clark Zervos, Thomas P. Zimmerman, Todd Willis, Greg Flexman, Jyoti Srivastava, Rebecca Silverstein, Melanie Williams, Pete Vandeberg, Jennifer L. Culp, Doug Burns, Vickie Barham, Amy Durham, David A. MalinzakAbstractA sudden, unprecedented failure of USP rabbit pyrogen tests for multiple 10% IGIV-C lots prompted a thorough investigation of the root cause for this phenomenon. All microbe-related testing, including Limulus amebocyte lysate test for endotoxin, proved negative, and no deficiencies were discovered in manufacturing. Plasma pool compos...
Source: Biologicals - April 23, 2019 Category: Biology Source Type: research

Comparison of different immunization routes on the immune responses induced by Mycobacterium tuberculosis ESAT-6/CFP-10 recombinant protein
Publication date: Available online 20 April 2019Source: BiologicalsAuthor(s): Mozhdeh Namvarpour, Majid Tebianian, Reza Mansouri, Seyyed Mahmoud Ebrahimi, Shiva KashkooliAbstractAccording to some difficulties against tuberculosis (TB) vaccination, development of new TB vaccines has been noted in recent years. Selection of proper route for vaccination is one of the most important factors for induction of good immune responses. Hence, in this study, the effects of different administration routes, including intranasal (I.N), subcutaneous (S.C) and intramuscular (I.M) on immune responses against Mycobacterium tuberculosis ESAT...
Source: Biologicals - April 21, 2019 Category: Biology Source Type: research

Correlation between the results of two analytical methods for measuring measles virus neutralizing antibodies in source plasma and therapeutic immunoglobulin products
Publication date: Available online 13 April 2019Source: BiologicalsAuthor(s): Jeungwoon Hong, Daegeun Kim, Younhee Won, Jungsoon Yoon, Kuk Jin Park, Jaetaek Oh, Chan-Wha KimAbstractPatients with primary immunodeficiency disorders are vulnerable to infectious diseases. Intravenous immunoglobulin (IVIG) therapeutic products manufactured from human plasma are employed widely to protect patients from pathogens such as measles virus, which causes a potentially fatal and contagious disease. Therefore, health authorities stipulate a minimum titer of measles neutralizing antibodies (mnAbs) in IVIG products to ensure efficient prot...
Source: Biologicals - April 14, 2019 Category: Biology Source Type: research

Use of a new RNA next generation sequencing approach for the specific detection of virus infection in cells
Publication date: Available online 13 April 2019Source: BiologicalsAuthor(s): Audrey Brussel, Kerstin Brack, Erika Muth, Rudolf Zirwes, Justine Cheval, Charles Hebert, Jean-Marie Charpin, Alice Marinaci, Benoit Flan, Horst Ruppach, Pascale Beurdeley, Marc EloitAbstractThe utilization of the current combination of in vitro, in vivo and PCR assays for the identification of adventitious viruses in production cells has a limited range of detection. While Next Generation Sequencing (NGS) has a broader breadth of detection, it is unable to differentiate sequences from replicating viruses versus background inert sequences. In ord...
Source: Biologicals - April 14, 2019 Category: Biology Source Type: research

Quality by Design characterization of the perfusion culture process for recombinant FVIII
Publication date: Available online 27 March 2019Source: BiologicalsAuthor(s): Yong Jae Kim, Sang Hoon Paik, Sang Kyul Han, Sunggeun Lee, Yoomin Jeong, Ji-youn Kim, Chan Wha KimAbstractA Quality by Design (QbD) concept was applied to characterize a cell culture process for production of the recombinant Factor VIII (rFVIII). We characterized the production bioreactor process and defined the design space by applying risk assessment to determine potential critical process parameters (CPPs) impacting critical quality attributes (CQAs). Characterization studies were subsequently performed using a qualified scaled-down model (SDM...
Source: Biologicals - March 28, 2019 Category: Biology Source Type: research