Next Generation Vaccine Manufacturing

Vaccine manufacturing can be a costly and complex process, often making life-saving vaccines unaffordable for resource poor countries. To help address these issues, the International Vaccine Institute (IVI) of Seoul, South Korea, and Merck have recently entered into a research agreement.

We spoke to Priyabrata Pattnaik, Ph.D., Director, Worldwide Vaccine Initiative, Merck, to learn more about the agreement and the role that Merck will play.

AM: Can you tell us about some of the complexities of manufacturing vaccines?

PP: Because, in general, vaccines are large molecular entities, they are naturally complex. Vaccines are not easy to characterize, even with the best techniques available, and it can be difficult to measure how the manufacturing process impacts the safety and efficacy of the finished product. Vaccines need to be made affordable while maintaining the best quality, and there is certainly room for improvement there.

Additionally, when considering therapeutics like biologics or small molecules, it is fairly easy to characterize their safety and efficacy because they are given to a sick patient who either recovers or does not, or extend the survival and then you know whether the drug works or not. But when you give a vaccine to a healthy individual the benefit is not immediately known and that definitely adds a layer of complexity.

AM: What are the aims of the research agreement between Merck and the IVI?

PP. We are really looking to change the way traditional vaccine manufacturing is done. The goal of this collaboration is to develop a standardized, next generation manufacturing process that will allow us to avoid the use of organic solvents and detergents. We are hoping to see whether the ideas we have to address these challenges are economically feasible, scientifically viable, and whether they improve productivity. Progress will take time, but we believe we are on the right path.

AM: What role will Merck play in the agreement?

PP. Merck is providing funding for this project and, perhaps more importantly, supplying our technical know-how. We have a strong understanding of the purification space and a strong market position in filtration and chromatography. We believe that IVI is the right collaborator which whom to leverage our expertise and technology to advance the process of vaccine manufacturing.

AM: What will the initial vaccine focus be? Why was this chosen?

PP. 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. Right now, the manufacturing process to develop these vaccines requires the use of organic solvents and detergents, and variations in the manufacturing process contribute to difficulties in standardization. The regulatory landscape is changing, and among these changes are environmental concerns around organic solvents and their disposal. The aim is to standardize a new manufacturing process that does not require the use of these organic solvents and detergents.

AM: Can you tell us more about Merck's corporate responsibility program?

PP. In realizing Merck's corporate responsibility, we focus our strengths on those areas where we can have the greatest impact. While our IVI partnership is not one of our Corporate Responsibility initiatives, it does align nicely with our goals. At Merck, we pursue three strategic spheres of activity, namely health, environment and culture. For instance, many people in low- to middle-income countries lack access to high-quality health solutions, so we leverage our expertise and collaborate with strong partners to create solutions for patients in developing nations. We also work non-stop to improve the sustainability footprint of our products while helping our customers achieve their own sustainability goals, and we consistently support cultural initiatives and educational programs across the globe. At Merck, acting responsibly means looking, listening and doing things better.