Biomedical Engineering and Bioengineering Commons^™

Design Of Experiment Based Japanese Encephalitis Virus Formaldehyde Inactivation Optimisation For A Vero Cell Derived Vaccine, Michael Hughson

Vaccine Technology III

Japanese Encephalitis (JE) is a disease primarily dominant in South East Asia, caused by the Japanese Encephalitis virus (JEV). It is responsible for an estimated 50,000 cases of the disease every year, of which around 10,000 are fatal and approximately 15,000 result in long term neurological sequelae (WHO 2006). Viral inactivation is a main feature in many vaccine manufacturing processes in order not only to inactivate the product itself but also any potential adventitious agents which may have been introduced during manufacture. Chemical inactivation using formaldehyde is one of the most common methods used for inactivated viral vaccines, yet due …

Development Of Protein Capsular Matrix Vaccine (Pcmv) Technology, Kevin P. Killeen, Ann Thanawastien, Tom Griffin

Vaccine Technology III

Matrivax R&D Corp. is a start-up biotechnology company with R&D operations located in Boston, USA and a vaccine pilot facility in Haikou, China. We are developing a proprietary vaccine process that entraps polysaccharides in a cross-linked protein ‘carrier’ or matrix, termed Protein Capsular Matrix Vaccine (PCMV), as an alternative to conjugate vaccine technology. Despite highly efficacious pneumococcal vaccines such as Prevnar®, S. pneumoniae causes > 1 million deaths worldwide annually. Likewise, typhoid fever afflicts ~16 million people, resulting in 600,000 deaths despite effective vaccines such as Typhim Vi® and Ty21a. The premise is that inexpensive,efficacious polysaccharide vaccines that elicit TH-cell ‘memory’ …

A Vaccine Prototype Using Baculovirus Expression System For The Control Of Avian Influenza Virus, Mauricio Realpe, R. Mora, L. Castellanos, F. Robles, C. González-Hernández

Vaccine Technology III

A clade 1 sequence of H5 haemaglutinin from an Asian Avian H5N1 isolate was used as a the template to chemically synthetize a codon optimized version for expression in insect cells. A single clone was chosen for expression optimization and changes were introduced in order to maximize the amount of protein to be produced and to resemble another sequence demonstrated to be present in an isolate causing disease in Humans.

Preliminary analysis at lab scale have shown promising yields of the haemaglutinin using an activity titration assay and an ELISA-based detection method. Optimization of the cell seeding, MOI, and time …

Purification Process Development Of Protein Subunit Based Vaccine Candidates Produced Using Recombinant E. Coli Expression System (Part - Ii), Davinder Chawla, Yan-Ping Yang

Vaccine Technology III

Proteins are key components of prophylactic vaccines against infectious diseases. Protein subunit based vaccine is an attractive alternative to the traditional detoxified bacterial or inactivated viral vaccine approach due to its highly purified and well characterized product nature. Purification of protein antigens to achieve consistent product purity and quality is an integral part of the protein subunit vaccine product development process. Expression levels of the recombinant proteins in bacterial expression system may be extremely high following rapid technology advancement. The challenges and approaches used to develop purification processes for novel protein vaccine candidates expressed at g/L level will be discussed.

Development Of A Multi-Dose Formulation For Prevnar 13™, Lakshmi Khandke, Cindy Yang, Jingrun Fan, Hanyoung Han, Ksenia Krylova Abbas Rashidbaigi, Bruce A. Green, Kathrin U. Jansen

Vaccine Technology III

Streptococcus pneumoniae causes up to a million cases per year of invasive disease in young children and infants, most occurring in developing countries. Pfizer is partnering with WHO and the GAVI alliance to support the developing world on immunization against pneumococcal disease. Prevnar 13™ is currently approved for the prevention of invasive pneumococcal disease in twenty seven countries. If used widely, this pneumococcal conjugate vaccine could prevent hundreds of thousands of additional cases of child mortality each year.

Use of single-dose preservative-free vaccine formulations will raise the overall cost of vaccination programs and may jeopardize the effectiveness of immunization programs …

Purification Process Development Of Protein Subunit Based Vaccine Candidates Produced Using Recombinant E. Coli Expression System (Part - I), Davinder Chawla, Yan-Ping Yang

Vaccine Technology III

Proteins are key components of prophylactic vaccines against infectious diseases. Protein subunit based vaccine is an attractive alternative to the traditional detoxified bacterial or inactivated viral vaccine approach due to its highly purified and well characterized product nature. Purification of protein antigens to achieve consistent product purity and quality is an integral part of the protein subunit vaccine product development process. Expression levels of the recombinant proteins in bacterial expression system may be extremely high following rapid technology advancement. The challenges and approaches used to develop purification processes for novel protein vaccine candidates expressed at g/L level will be discussed.

Human Cells For Prostate Cancer Vaccine Therapy - The Impact Of Centrifugation Upon Key Product Quality Attributes, Michael Delahaye, Katherine Lawrence, Carol Chu Mike Hoare, Stephen Ward

Vaccine Technology III

Centrifugation is a unit operation used within a wide range of bioprocesses, including the production of a whole cell cancer vaccine to treat Hormone Refractory Prostate Cancer (HRPC) which has been tested in Phase II clinical trials. To quantify the effect of centrifugation-related stresses upon a whole cell vaccine population, a design of experiments (DOE) based investigation at micro-scale was implemented. Qualification of the cells may be by membrane integrity and by surface marker density as well as cytokines released and retained during bioprocessing. These and possibly other factors combine to affect the biopotency of the cells and their clinical …