Combining Expertise, The Wistar Institute and Batavia Biosciences Partner to Expand Rubella Vaccine Manufacturing Around the World
Companies that make rubella vaccines have been getting harder and harder to come by. The global production of the rubella vaccine, supplied in combination with measles, mumps and varicella vaccines, which is the typical route for rubella immunization, is limited to a small number of manufacturers, which could threaten the ongoing global supply of these critical medicines.
This situation is exactly what The Wistar Institute wants to avoid. In the 1960s at Wistar, Stanley A. Plotkin, M.D., now a professor emeritus, developed the rubella vaccine that put an end in much of the world to the epidemics that caused infants to be born deaf and have other defects. Dr. Plotkin’s vaccine strain is used today in most of the 173 countries that include rubella in their national immunization programs. “As the originator of the rubella vaccine, Wistar has a mission to protect its longevity,” said Heather Steinman, Ph.D., MBA, Wistar’s vice president for business development.
To that end, Wistar has made strides over the years licensing the rubella vaccine to companies in developing countries. But that approach has downsides. It can take companies many years to bring the vaccine, which Wistar supplies as research-grade seed stock called RA 27/3, through the many stages of testing, manufacturing and clinical development that are required before the rubella vaccine can be administered to people. It is a substantial investment of resources for vaccine manufacturers, and at the end of it, there is little to no profit for the vaccine manufactures, noted Heather.
A new partnership that Wistar announced in April 2020 with Batavia Biosciences, based in the Netherlands, is poised to overcome these hurdles and quickly expand access of this critical vaccine in developing countries. Together the non-profit and industry pair can deliver new vaccine manufacturers all the resources to get up and running. Wistar will provide its vaccine seed stock while Batavia will rely on its extensive vaccine production expertise to support technology transfer and assist vaccine manufacturers throughout the preclinical and clinical development processes. “Public-private partnerships are critical to fixing global problems, it just made sense for Batavia and Wistar to work together,” Heather said.
This international academic-industry collaboration would not be possible without funding from a non-profit partner, the Bill & Melinda Gates Foundation. Wistar received a $1M grant at the end of 2019 to allow the institute to archive its RA 27/3 seed stock and transfer the necessary supplies to Batavia. “The generous support from the Gates Foundation, which like us has a mission to address some of the world’s most pressing global health challenges, has had a tremendous impact on our partnership with Batavia and has allowed us to advance the work on rubella vaccines beyond Wistar,” said Anita Pepper, Ph.D., Wistar’s vice president for institutional advancement.
Packaging Expertise
The Wistar-Batavia partnership means that vaccine manufacturers that license the rubella vaccine from Wistar will receive a “complete starter kit” of information to speed their entry into the market, said Christopher Yallop, Ph.D., chief operations and scientific officer of Batavia Biosciences. The package, which should be ready by the first half of 2022, will include the production methods that Batavia developed, as well as the virus stock and cells that the company can grow in their facility to propagate more virus. And because Batavia will provide the virus produced using GMP (good manufacturing practice), companies can use it to start clinical trials immediately, as they will have to do to validate the vaccine’s effectiveness and safety in their region.
On top of the one-stop-shop nature of the package, vaccine manufacturers may choose to further benefit by receiving methods that Batavia developed to make rubella vaccine production more efficient. By using new approaches to manufacture the vaccine and new types of equipment, Batavia managed to intensify the process to propagate virus by about 20-fold, which in turn reduces the number of people involved, the overhead and materials costs, reducing the overall cost of the vaccine.
“Many of the vaccines that have been around since the 60s and 70s are made with technologies that were developed in the 60s and 70s so they are not really up-to-date,” Chris said. By increasing production efficiency, “companies can sell the vaccine at a price that the world can pay while being sustainable for them.” Batavia has been involved in collaborations with other academic partners, which were supported by the Gates Foundation, to improve efficiency of production of many global health vaccines including polio, measles & rubella and rotavirus vaccines.
Rolling Out
Now that the Wistar-Batavia collaboration has hit its major milestones, it is ready to set up licensing agreements with interested vaccine manufactures and ship out the package. Both partners expect this step to be an easy one, with the extensive networks of vaccine manufacturers they each have in developing countries. Wistar is already working with vaccine manufacturers in underrepresented countries, Heather noted. India is one of a growing number of countries to add the rubella vaccine to its childhood immunization program, which it did in 2017.
As companies work to join the rubella vaccine market, they will invariably encounter technical issues and require support. Batavia will be the main go-to for addressing these issues, although Wistar will also be involved if they can offer guidance based on their decades of experience growing and studying the rubella vaccine strain, Chris noted.
Speaking to the unique strengths of the academic-industry partnership, Chris highlighted the extensive and complementary skill sets of Wistar and Batavia. No academic research center, whether a small private institute such as Wistar or a large university, can invest the time to develop the vaccine production conditions as Batavia and other life sciences can. On the other hand, Batavia does not have Wistar’s long history of discovery and study of the vaccine. The two are already discussing how they can apply the model for rubella vaccine production to other vaccines and medicines.
“From discovery of the vaccine to licensing, it is almost like Wistar is the beginning and the end of the rubella vaccine chain,” said Anita.
Written by, Carina Storrs, Ph.D.