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qbd vaccine

Sunita Minz, Ravi Shankar Pandey
Traditional parenteral recombinant hepatitis B virus (HBV) vaccines have effectively reduced the disease burden despite being able to induce seroprotective antibody titers in 5-10% vaccinated individuals (non-responders). Moreover, an estimated 340 million chronic HBV cases are in need of treatment. Development of safe, stable, and more effective hepatitis B vaccine formulation would address these challenges. Recombinant hepatitis B surface antigen (rHBsAg) entrapped solid fat nanoemulsions (SFNs) containing monophosphoryl lipid A (MPLA) that was prepared and optimized by quality by design (QbD) using response surface methodology (RSM), i...
April 2018: AAPS PharmSciTech
Luca Nompari, Serena Orlandini, Benedetta Pasquini, Cristiana Campa, Michele Rovini, Massimo Del Bubba, Sandra Furlanetto
Bexsero is the first approved vaccine for active immunization of individuals from 2 months of age and older to prevent invasive disease caused by Neisseria meningitidis serogroup B. The active components of the vaccine are Neisseria Heparin Binding Antigen, factor H binding protein, Neisseria adhesin A, produced in Escherichia coli cells by recombinant DNA technology, and Outer Membrane Vesicles (expressing Porin A and Porin B), produced by fermentation of Neisseria meningitidis strain NZ98/254. All the Bexsero active components are adsorbed on aluminum hydroxide and the unadsorbed antigens content is a product critical quality attribute...
February 1, 2018: Talanta
Sumeet Gupta, Vikas Jhawat
Conventional approaches of drug discovery are very complex, costly and time consuming. But after the completion of human genome project, applications of pharmacogenomics in this area completely revolutionize the drug discovery and development process to produce a quality by design (QbD) approach based products. The applications of two areas of pharmacogenomics i.e. structural and functional pharmacogenomics excel the drug discovery process by employing genomic data in drug target identification and evaluation, lead optimization via high throughput screening, evaluation of drug metabolizing enzymes, drug transporters and drug receptors using computer aided technique and bioinformatics library data base...
January 10, 2017: Journal of Controlled Release: Official Journal of the Controlled Release Society
Daniel M Czajkowsky, Jan Terje Andersen, Anja Fuchs, Timothy J Wilson, David Mekhaiel, Marco Colonna, Jianfeng He, Zhifeng Shao, Daniel A Mitchell, Gang Wu, Anne Dell, Stuart Haslam, Katy A Lloyd, Shona C Moore, Inger Sandlie, Patricia A Blundell, Richard J Pleass
The remarkable clinical success of Fc-fusion proteins has driven intense investigation for even more potent replacements. Using quality-by-design (QbD) approaches, we generated hexameric-Fc (hexa-Fc), a ~20 nm oligomeric Fc-based scaffold that we here show binds low-affinity inhibitory receptors (FcRL5, FcγRIIb, and DC-SIGN) with high avidity and specificity, whilst eliminating significant clinical limitations of monomeric Fc-fusions for vaccine and/or cancer therapies, in particular their poor ability to activate complement...
April 27, 2015: Scientific Reports
Piergiuseppe Nestola, Cristina Peixoto, Ricardo R J S Silva, Paula M Alves, José P B Mota, Manuel J T Carrondo
The downstream processing of virus particles for vaccination or gene therapy is becoming a critical bottleneck as upstream titers keep improving. Moreover, the growing pressure to develop cost-efficient processes has brought forward new downstream trains. This review aims at analyzing the state-of-the-art in viral downstream purification processes, encompassing the classical unit operations and their recent developments. Emphasis is given to novel strategies for process intensification, such as continuous or semi-continuous systems based on multicolumn technology, opening up process efficiency...
May 2015: Biotechnology and Bioengineering
Jessica Paul, Sonja Jensen, Arthur Dukart, Gesine Cornelissen
In 2000 the implementation of quality by design (QbD) was introduced by the Food and Drug Administration (FDA) and described in the ICH Q8, Q9 and Q10 guidelines. Since that time, systematic optimization strategies for purification of biopharmaceuticals have gained a more important role in industrial process development. In this investigation, the optimization strategy was carried out by adopting design of experiments (DoE) in small scale experiments. A combination method comprising a desalting and a multimodal ion exchange step was used for the experimental runs via the chromatographic system ÄKTA™ avant...
October 31, 2014: Journal of Chromatography. A
Jennifer Haas, Andrew Franklin, Matthew Houser, David Maraldo, Mark Mikola, Roberto Ortiz, Elizabeth Sullivan, José M Otero
This case study provides an example of how Quality by Design (QbD) principles were applied to accelerate process development to manufacture a vaccine candidate at commercial scale. By leveraging an existing manufacturing platform process, a risk assessment was used to differentiate process parameters that could be defined using a combination of scientific and historical manufacturing knowledge from those that merited additional process characterization by experimentation. Select parameters, and their interactions, were evaluated by a Design of Experiment (DoE) series...
May 19, 2014: Vaccine
Aaron Noyes, Ranga Godavarti, Nigel Titchener-Hooker, Jonathan Coffman, Tarit Mukhopadhyay
The rapid development of purification processes for polysaccharide vaccines is constrained by a lack of analytical tools current technologies for the measurement of polysaccharide recovery and process-related impurity clearance are complex, time-consuming, and generally not amenable to high throughput process development (HTPD). HTPD is envisioned to be central to the improvement of existing polysaccharide manufacturing processes through the identification of critical process parameters that potentially impact the quality attributes of the vaccine and to the development of de novo processes for clinical candidates, across the spectrum of downstream processing...
May 19, 2014: Vaccine
Helen Yarovoi, Tina Frey, Silikhone Bouaraphan, Mary Retzlaff, Thorsten Verch
BACKGROUND: As quality by design (QbD) for pharmaceutical product development is being expanded to include analytical methods, we applied QbD to the development of antigenicity assays measuring in vitro relative potency of a quadrivalent vaccine candidate. RESULTS: After establishing development targets together with customers, immunoassays were developed to meet objectives. Statistical design of experiments was used to optimize method parameters and establish a design space...
October 2013: Bioanalysis
Pall Thor Ingvarsson, Mingshi Yang, Helle Mulvad, Hanne Mørck Nielsen, Jukka Rantanen, Camilla Foged
PURPOSE: The purpose of this study was to identify and optimize spray drying parameters of importance for the design of an inhalable powder formulation of a cationic liposomal adjuvant composed of dimethyldioctadecylammonium (DDA) bromide and trehalose-6,6'-dibehenate (TDB). METHODS: A quality by design (QbD) approach was applied to identify and link critical process parameters (CPPs) of the spray drying process to critical quality attributes (CQAs) using risk assessment and design of experiments (DoE), followed by identification of an optimal operating space (OOS)...
November 2013: Pharmaceutical Research
Michael Li, Ye Xian Qiu
An effective downstream bio-processing of vaccine products requires complete chemical knowledge of the contaminants that may arise from a given vector expression system. Whether the vaccine is made from the traditional egg-based or the new cell-cultured process, it is the expression system that determines the types of impurities that need to be identified and removed from the vaccine product. There are mechanical and chemical factors that can either reduce the yield or render a vaccine product to be irreversibly inactive...
February 18, 2013: Vaccine
Jessica O Josefsberg, Barry Buckland
The evolution of vaccines (e.g., live attenuated, recombinant) and vaccine production methods (e.g., in ovo, cell culture) are intimately tied to each other. As vaccine technology has advanced, the methods to produce the vaccine have advanced and new vaccine opportunities have been created. These technologies will continue to evolve as we strive for safer and more immunogenic vaccines and as our understanding of biology improves. The evolution of vaccine process technology has occurred in parallel to the remarkable growth in the development of therapeutic proteins as products; therefore, recent vaccine innovations can leverage the progress made in the broader biotechnology industry...
June 2012: Biotechnology and Bioengineering
Eniko R Toke, Orsolya Lorincz, Eszter Somogyi, Julianna Lisziewicz
DermaVir vaccine is a novel "pathogen-like" nanomedicine containing a plasmid DNA complexed with a polyethylenimine that is mannobiosylated to target antigen-presenting cells and to induce immune responses (pDNA/PEIm). To develop a commercially viable vaccine product we have systematically investigated the variability of raw materials and their relationship with the product's biological activity. We demonstrated that the cGMP quality requirements are not sufficient to reproducible formulate the nanomedicine with optimal biological activity...
June 15, 2010: International Journal of Pharmaceutics
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