Expression and purification of an immunogenic SUMO-OmpC fusion protein of Salmonella Typhimurium in Escherichia coli
The objective of this work was to attain high level expression of rOmpC protein, purify and evaluate its functional properties. The ompC gene was optimized and fused with small ubiquitin-related modifier (SUMO) gene for high level expression as soluble protein. The fusion protein with ~58 kDa molecular weight was observed on SDS-PAGE gel. The expression levels of rOmpC fusion protein reached maximum of 38% of total soluble protein (TSP) after 8 h of 0.2% rhamnose induction. Protein purification was carried out using nickel nitrilotriacetic acid (Ni-NTA) purification column. Western blot were performed to analyse expres...
Source: Biologicals - October 25, 2019 Category: Biology Source Type: research
Quality assessment and its impact on clinical performance of a biosimilar erythropoietin: A simulated case study
Publication date: Available online 25 October 2019Source: BiologicalsAuthor(s): Robin Thorpe, Gustavo Grampp, Hye-Na Kang, Ivana KnezevicAbstractThe case study described in this paper was developed for the purpose of training for a better understanding of principles relating especially to a comprehensive evaluation of multiple quality attributes as outlined in the WHO guidelines on evaluation of similar biotherapeutic products. It is also to emphasize the importance of an understanding of the critical quality attributes and a risk assessment of the impact on clinical performance. It was prepared to mimic a real situation i...
Source: Biologicals - October 25, 2019 Category: Biology Source Type: research
Quality changes to approved biotherapeutic product: Simulated case studies on reporting categories & supporting data requirements
Publication date: Available online 24 October 2019Source: BiologicalsAuthor(s): Hugo Hamel, Hye-Na KangAbstractChanges are essential for the continual improvement of the manufacturing process and for maintaining state-of-the-art controls on biotherapeutic products and such changes often need to be implemented after the product has been approved. WHO guidelines on procedures and data requirement for changes to approved biotherapeutic products were issued in 2017 to provide guidance to national regulatory authorities and manufacturers on the regulation of changes to already licensed biotherapeutic products in order to assure...
Source: Biologicals - October 25, 2019 Category: Biology Source Type: research
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 14, 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 both form...
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 and th...
Source: Biologicals - September 11, 2019 Category: Biology Source Type: research
