Vaccines
Process Development and Application Expertise

Collaboration

Accelerating Vaccine Development

Vaccines & Viral Therapy Process:

Biopharmaceutical
Applications Guide

Our collaborations with worldwide vaccine developers and researchers enable faster, better vaccine development. Our technical expertise combined with process insights from our key partners are transforming vaccine manufacturing.

Integrated and flexible manufacturing platform for viral vaccine production
Bill & Melinda Gates Foundation

A number of factors limit complete global immunization coverage, including prohibitive costs for procuring and distributing vaccines in lower income countries. A substantial reduction in the cost of manufacturing vaccines could help enable affordable, equitable and sustainable immunization on a global scale. A consortium which includes our Natrix® offering, Univercells and Batavia has been awarded a $12 million grant by the Bill & Melinda Gates Foundation for the development of a breakthrough vaccine manufacturing platform with the objective of radically lowering costs and increasing vaccine availability and affordability in developing countries.

The consortium is developing a manufacturing platform that integrates continuous processing with process intensification. This combination allows miniaturization of commercial manufacturing to the point where it can be performed in locally deployed, self-contained, small footprint, low-cost micro-facilities. The platform will leverage Univercells’ process intensification and integration capabilities; using our Natrix® novel single-use chromatography membrane platform; and Batavia’s vaccine development and manufacturing capabilities. The initial target is to establish a micro-facility for inactivated polio vaccine (sIPV) that can deliver 40 million doses of trivalent vaccine per year at a manufacturing cost of less than $0.15 per dose. The platform concept can be applied to any viral vaccine.

More information:
Univercells and consortium partners Natrix Separations and Batavia Biosciences Receive $12 Million Grant from Bill & Melinda Gates Foundation to Radically Reduce Vaccine Cost for Developing Countries

Addressing Low Yields and High Costs of Vaccine Purification
DiViNe Consortium

Purification steps can account for a large part of the manufacturing of most biological drugs. In the vaccine industry, purification processes are particularly complex as vaccines aim at protecting healthy people. Any contaminant must be removed via multiple purification steps which comes at the expense of product recovery. Yields are low and product costs are high.

We have joined the DiViNe project, a European consortium of six companies to address the biggest challenges facing the development, manufacture and delivery of vaccines. The partners will work together to develop affinity chromatography solutions an integrated purification platform amenable to diverse heterogeneous types of vaccines such as glycoconjugates, virus like particles and viruses.

Also in the consortium are Affilogic (France), Aquaporin (Denmark), GenIbet Biopharmaceuticals (Portugal) and GlaxoSmithKline (Italy). The project will be coordinated by iBET (Portugal) and has received funding from the European Union's Horizon 2020 research and innovation program.

More information:
{hCompanyKGA}, Joins DiViNe Consortium to Address Low Yields, High Costs of Vaccine Purification Processes

Accelerating development of viral vector vaccines
Jenner Institute

Viral vectors are a promising platform for vaccine development due to the ability to reliably induce cell-mediated immunity, which is essential for complex diseases such as AIDS, malaria etc. The prospect of repurposing a single virus production template in order to quickly respond to different diseases is very attractive. However, the current production process is complicated and time consuming.

Through a collaboration with the Jenner Institute of Oxford University, we seek to improve the manufacturing process for adenovirus vaccines. This project aims to change the current labor-intensive and non-scalable process by switching from shake flasks to a more efficient single-use bioreactor platform that uses novel filtration and ion exchange chromatography technologies. This process will allow an increase in titers that meet purity levels while meeting cost requirements.

Advancing vaccine development and manufacturing for neglected diseases
Baylor College

Neglected tropical diseases are a group of infectious diseases which commonly disproportionately affect populations in developing countries. According to WHO, these diseases affect one billion people and cost billions of dollars to developing economies every year. Despite of importance for global health, vaccine development for these diseases faces several technical and financial challenges. Development of a high yield and low-cost manufacturing process is key for such vaccine development projects.

We have formed a strategic alliance with Baylor College of Medicine, Houston, Texas to advance vaccine research and development for neglected and emerging infections. The collaboration focuses on bringing vaccines through development to efficiently deliver them to societies in need. Our experts in process development and formulation are working with Texas Children’s CVD scientists at Baylor to optimize the vaccine manufacturing process to increase vaccine stability and yield. Initially, these activities are targeting schistosomiasis, a deadly parasitic disease that affects millions of people a year in tropical and subtropical regions.

Debottlenecking purification of polysaccharide vaccines
International Vaccine Institute

With a rapidly expanding pipeline of conjugated polysaccharide vaccines, the global pharmaceutical industry needs modern processes for purification to ensure high-quality, affordable vaccines. Complex manufacturing processes, along with poor yield and recovery, result in vaccines that are not easily affordable by resource-challenged countries. Even for established vaccine manufacturers in the United States and Western Europe; purification can be the biggest bottleneck in polysaccharide vaccine manufacturing.

To address this, we are collaborating with the International Vaccine Institute (IVI) of Seoul, South Korea. This collaboration is aimed at improving the manufacturing process to deliver greater yield, allowing higher recovery and purity for vaccines. Initially, the project will focus on a vaccine for typhoid, with the goal of applying findings to the processes for pneumococcal, meningococcal, haemophilus, staphylococcus, streptococcus B and other conjugated polysaccharide vaccines.

More information:
Press Release, June 28, 2016
{hCompany} to Develop Next-Generation Purification Processes with International Vaccine