MilliporeSigma, Merck KGaA’s life science service provider, is teaming with the University of Oxford’s vaccine-focused research body, the Jenner Institute, to develop more cost-effective vaccine manufacturing processes.
The partnership aims to improve the production of vaccines that use adenovirus as vectors. With 30 years’ experience in viral vector manufacturing, MilliporeSigma will contribute its products, systems and technologies for the pair to develop a closed manufacturing process that happens in a cleanroom to minimize contamination and ensure product safety.
That sort of upgraded manufacturing process would be cost-effective and transferable so that it could be applied worldwide. More affordable production would help “facilitate access to affordable vaccines while improving the global response to disease outbreaks,” said MilliporeSigma CEO Udit Batra in a statement.
To be specific, MilliporeSigma will provide all technologies for screening and process development including its Mobius single-use bioreactors and assemblies, cell culture media, Benzonase reagent, clarification, bioburden, sterile and tangential flow filtration filters, the company told FiercePharma. The Jenner Institute will be the owner of the developed process.
Adenovirus is a popular viral vector for vaccine development. It has been used in vaccine candidates against tuberculosis, HIV, Ebola, malaria and influenza. In fact, it was the first DNA virus vector to enter rigorous therapeutic development, “largely because of its well-defined biology, its genetic stability, its high gene transduction efficiency and its ease of large-scale production,” according to a 2017 study published in Genes & Diseases. But producing the first generation of an adenoviral vector remains a technically challenging and time-consuming process, said the study.
Because of their efficient gene delivery feature, adenovirus vectors also hold promise outside of infectious diseases and in the hot area of gene- and cell-based therapies for cancer and genetic and regenerative diseases.
MilliporeSigma and Jenner hope to change the current labor-intensive and nonscalable process by switching from shake flasks to single-use bioreactors for upstream production of viruses and using filtration and ion exchange chromatography technologies that will allow to increase titers and meet purity and cost requirements, according to the company.
“[T]he newly developed process should match or exceed our existing process in terms of productivity and purity,” said Adrian Hill, director of the Jenner Institute, in a statement. “Such improvements should help advance the development of clinical-grade, injectable drug product for use in clinical trials and other research applications.”
MilliporeSigma has several vaccine tie-ups with the research community. Last August, it reached a deal with Baylor College of Medicine to develop vaccines against serious but neglected emerging diseases, with an initial focus on schistosomiasis. In 2016, it teamed up with the International Vaccine Institute of Seoul to also work on more robust, scalable vaccine manufacturing processes. That project focuses on a vaccine for typhoid and is expected to apply findings to the processes for pneumococcal, meningococcal, Haemophilus, streptococcus B and so on.
Separately, MilliporeSigma plans to build a vaccine manufacturing facility in Ghana, making the country the first in sub-Saharan Africa to have a dedicated human vaccine manufacturing facility.
Editor's Note: This story has been updated to include additional information from MilliporeSigma on the development plan.