Engineering Commons^™

Vaccination As A Tool To Reduce Antimicrobial Resistance Worldwide, Bernard Vallat, Elisabeth Erlacher

Vaccine Technology VI

Antimicrobial resistance is a global human and animal health concern that is influenced by the non-appropriate use of antimicrobial agents in both human and veterinary medicine, as well as in the plant sector. To combat antimicrobial resistance, the World Organisation for Animal health (OIE) has developed science-based intergovernmental standards and guidelines covering terrestrial animals and aquaculture.

The OIE also contributed to the development of the WHO Global Action Plan on Antimicrobial Resistance, adopted in 2015 by the World Health Assembly. The 180 Member Countries of the OIE expressed their support to this plan of action through a Resolution, …

Plant-Based Technologies To Enable Rapid Response To Ebola Outbreak, Jerzy Karczewski, Vidadi Yusibov

Vaccine Technology VI

Ebola is a rare and deadly disease caused by infection with a strain of Ebola virus (Zaire, Sudan or Marburg). Ebola is spread through a direct contact with body fluids of infected patients. The recent Ebola outbreak affected multiple countries in West Africa and clearly demonstrated a need for development of technologies enabling production of adequate supply of vaccines and therapeutics to treat infected patients. We have undertaken efforts to develop methods and produce plant-based recombinant vaccine as well as a series of monoclonal antibodies to fight Ebola infection.

Several approaches were carried out to develop vaccines based on recombinant …

How To Deliver New Vaccines Under Very Short Timelines: The Zapi Project, Jean-Christophe Audonnet

Vaccine Technology VI

The ZAPI project is the first One Health project in the European Innovative Medicine Initiative (IMI) program. Its objective is to define and validate unique methodologies that can be applied when new zoonotic infectious diseases will occur in Europe or other regions of the world. The project is supporting an entirely new approach for “anticipating the unexpected”, and is defining new ways to alleviate the technical constraints which are typically encountered with the classical vaccine development processes.

The ZAPI project involves a total of 20 partners, from academic, biotech, and industry origin. One important feature of ZAPI is that it …

Session V: Getting Vaccines To The Market: Case Studies, Rebecca Sheets, Grimalkin Partners, Danilo Casimiro

Vaccine Technology VI

This is a presentation of Session V.

(No Abstract)

Determining Whether Adsorption State Is A Critical Attribute In Aluminum Adjuvanted Vaccines, Garry Morefield

Vaccine Technology VI

Aluminum based adjuvants have a long history of safe and effective use in vaccine products. When developing vaccine formulations incorporating aluminum adjuvants it is important to understand whether adsorption state is a critical attribute of the vaccine. Investigations initiate with obtaining an understanding of how the antigen of interest interacts with aluminum adjuvant surfaces. The balance of attractive versus repulsive interaction forces (including electrostatic, ligand exchange, and hydrophobic interactions) determines the resulting adsorption state of the antigen. Once the interaction of aluminum adjuvant and antigen is understood, formulations can be prepared along the spectrum of aluminum adjuvant surfaces to obtain …

Development, Manufacturing, And Supply Of Msd’S Ebola Vaccine, Jeffrey T. Blue

Vaccine Technology VI

Ebola was first discovered in 1976 and is a member of the filoviridae family of viruses. There are multiple strains of Ebola and infection can lead to hemorrhagic fever and death. In March 2014, a historic Ebola outbreak occurred in three Western African countries, Guinea, Liberia, and Sierra Leone. Over 28,000 cases were reported and led to more than 11,000 deaths, more than ten times the amount of cases compared to all past outbreaks combined. On August 8^th 2014, the World Health Organization declared a Public Health Emergency of International Concern (PHEIC). Merck Sharp & Dohme (MSD) partnering with …

Improving Global Human Health Through Norovirus Virus-Like Particle Manufacturing, Scot Shepard

Vaccine Technology VI

Norovirus infection is the most common cause of acute gastroenteritis in the U.S., estimated to afflict 21 million people per year. For scale-up manufacturing of a norovirus vaccine candidate, the baculovirus expression system has been used in 1000 L working volume stirred-tank bioreactors for production of two distinct norovirus virus-like particles (VLP). Downstream processing using methods for enveloped virus inactivation and a series of orthogonal chromatography steps results in norovirus VLP that contain low residual levels of host-cell protein, host cell and baculovirus DNA, and are free of replicating baculovirus. Emphasis has been placed on employing single-use technologies including disposable …

Combining Doe With An Empirical Approach To Improve Vaccine Formulation Development, Jill Livengood, Tim Powell, Melissa Bushey

Vaccine Technology VI

Vaccine development and formulation is based upon understanding of the candidate’s target product profile, and leverages knowledge and experience in pharmaceutical products. Developing an optimal formulation takes into account factors such as ensuring route of administration, product stability, and identifying Quality Target Product Profiles that are suitable for the product’s intended use. Based upon such knowledge and experience, multiple excipient formulations may be first identified for initial screening. Achieving the QTPP is a measure of results, and can be achieved with screening formulations by aggressive accelerated stability study conditions to enable the final formulation components to be down-selected. This presentation …

Controlled, Pulsatile Release Of Thermostabilized Inactivated Polio Vaccine From Plga-Based Microspheres, Stephany Y. Tzeng, Rohiverth Guarecuco, Kevin J. Mchugh, Evan M. Rosenberg, Yingying Zeng, Robert Langer, Ana Jaklenec

Vaccine Technology VI

Many vaccines, such as the inactivated polio vaccine (IPV), must be administered in several doses for full efficacy. Because patient access is a major challenge for vaccination efforts in developing countries, administering multiple doses per patient is impractical in those areas. Single-administration vaccines would greatly improve efforts to vaccinate populations in Third World countries, and the World Health Organization (WHO) Expanded Program for Immunization describes an ideal vaccine as one that is heat-stable, requires only one shot, and is easy to administer. Although already existing technologies, such as microspheres composed of poly(lactic-co-glycolic acid) (PLGA), are able to encapsulate …

Development Of Typhax, A Salmonella Typhi Vi Polysaccharide Protein Capsular Matrix Vaccine, Kevin P. Killeen

Vaccine Technology VI

Matrivax Research & Development Corporation is researching and developing a novel technology termed Protein Capsular Matrix Vaccine (PCMV) as an alternative to polysaccharide-protein conjugate vaccines. In a PCMV, polysaccharide antigens are entrapped in a cross-linked protein ‘carrier’ matrix. This process is simpler than conjugate vaccines and should yield polysaccharide vaccines that elicit T_H-cell ‘memory’, are highly efficacious, and less expensive to manufacture.

Typhoid fever, caused by Salmonella enterica serovar Typhi, is a disease that afflicts ~16 million people worldwide, resulting in 600,000 deaths, annually. Although typhoid fever vaccines are commercially available, there are significant limitations. Ty21a is an …

Characterization Of Ha And Na-Containing Vlps Produced In Suspension Cultures Of Hek 293 Cells, Amine Kamen, Alina Venereo-Sanchez, Rénald Gilbert, Aziza Manceur, Parminder Chahal, Sven Ansorge, Wangxue Chen

Vaccine Technology VI

Virus like particles (VLPs) can be formulated into promising vaccines to prevent influenza infection. In addition of having a structure and composition that mimic the wild type virus, VLPs are safe since they are devoid of viral genes and consequently are not infectious. One approach to scale up the manufacturing of VLPs is to produce them in a serum-free suspension culture using a stable mammalian cell line. Importantly, with VLPs synthetized by mammalian cells, the post-translational modifications of the surface antigens should be similar to the wild type virus, and therefore should trigger a potent and specific immune response for …

Conference Program (Vaccine Technology Vi), Laura A. Palomares, Tarit Mukhopadhyay, Manon Cox, Nathalie Garçon

Vaccine Technology VI

No abstract provided.

Vaccines: Reaching For Higher Branches After The Low Hanging Fruit Has Been Picked, Michael G. Kurilla

Vaccine Technology VI

Vaccines represent one of the most significant advances by medicine in addressing infectious diseases being responsible for the elimination of a few and the virtual eradication of several other scourges. In addition, medicine is also beginning to appreciate the potential applicability of vaccines beyond infectious diseases to areas such as oncology. During any emerging infectious disease public health event, availability of a vaccine figures prominently in the assessment of the capability to address the threat most effectively. A more rapid deployment of new vaccines would enable more effective management of emerging threats. Efforts to streamline manufacture and production of vaccines …

Immunization With Surface Immunogenic Protein Induces A Decrease Of Vaginal Colonization By Group B Streptococcus In An Experimental Mouse Model, Jorge A. Soto, Abel E. Vasquez, Diego Diaz-Dinamarca, Daniel A. Soto, Robert Rojas, Alexis M. Kalergis

Vaccine Technology VI

The Group B streptococcus (GBS) is the leading cause of neonatal sepsis and meningitis in developed countries and an emerging pathogen in adults. A neonatal infection occurs predominantly during the delivery by either inhalation or ingestion of contaminated secretions of the mother’s vagina. Maternal screening by rectovaginal GBS colonization at 35–37 weeks of gestation, with subsequent intra-partum antibiotic prophylaxis (IAP) at the onset of labor, is implemented in some countries to prevent newborn invasive by GBS. Currently, there are not vaccines to prevent the devastating consequences of GBS and a glycoconjugate vaccine is under clinical experimentation (Clinical Trials Phase III). …

Production Of A Nanoplasmid™ With A Large Gene Insert Using The Hypergro™ Fermentation Process, Aaron Carnes, Neha Tiwari, Jill Beilowitz, Carlos Sampson, Dorothy Peterson, Jim Williams

Vaccine Technology VI

Plasmid based DNA vaccines are emerging as a promising alternative to traditional vaccines due to several advantages, including faster production of DNA plasmids using E. coli. However, further increases in transgene expression are needed to meet efficacy requirements for various non-viral gene therapy and DNA vaccination applications. While existing minicircle DNA technology has been shown to offer improved levels and durations of transgene expression by removal of the bacterial region from the plasmid, low manufacturing yields may be a barrier to widespread use of minicircle DNA for vaccination.

NTC’s minimalized Nanoplasmid™ vectors utilize RNA-OUT (R_OUT) antibiotic-free selection …