Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it has signed an agreement with Spicona, Inc. to develop a virus-like protein (VLP)-based vaccine against COVID-19. Under the terms of the agreement, Catalent will use its proprietary GPEx® cell line development technology to develop a cell line expressing the recombinant VLP at its Madison, Wisconsin facility.
Spicona is focused on research and development in the field of immunology and vaccinology. Its pipeline is being built around novel compounds for the prevention and treatment of infectious diseases, with an immediate focus on the development of a novel, safe and protective COVID-19 vaccine. Spicona is led by a team of experienced vaccine experts headed by Dr. Kaspar Bänziger, Dr. Reinhard Glück, and Dr. Gaurav Gupta, together with a prestigious international advisory board, whose members have been involved in the development of several vaccines, including the severe acute respiratory syndrome (SARS) vaccine in 2003. Today, millions of children and adults are safely immunized with vaccines developed and brought to market by the experts who make up the Spicona team.
Catalent’s GPEx technology creates stable, high-yielding mammalian cell lines with high speed and efficiency. The advantages of applying GPEx technology span from early feasibility studies to clinical manufacturing, through to commercial-scale production. GPEx technology is used with therapeutic candidates in more than 120 ongoing clinical trials.
“We feel privileged to start this collaboration with Catalent, which we consider the best partner for the development of a novel COVID-19 vaccine candidate,” commented Kaspar Bänziger, CEO, President, Spicona, Inc. “Together, our two experienced teams will work toward finding a safe and efficacious solution to prevent COVID-19 as soon as possible.”
“Catalent’s GPEx technology and the Madison facility provide proven technology and expertise that are a perfect fit for Spicona’s unique vaccine approach to address COVID-19.” commented Mike Riley, Region President, Catalent Biologics, North America. He added, “We are pleased to be working with Spicona and other partners on all major classes of COVID-19 vaccines in development.”
Catalent’s Madison facility provides mammalian cell line development, process development, process validation, formulation development and drug substance manufacturing ranging from pre-clinical to commercial stage. The site recently commenced an expansion to provide additional clinical and commercial production capacity at the 2,000 or 4,000-liter batch scale.