NEW YORK and SOMERSET, N.J. – June 10, 2020 — 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.
Spicona is focused on research and development in the field of immunology and vaccinology and is currently building a pipeline of novel compounds for the prevention and treatment of infectious diseases. The company is led by a team of experienced vaccine experts headed by Dr. Kaspar Bänziger, Dr. Reinhard Glück and Dr. Gaurav Gupta, who have developed several new vaccines, including a SARS vaccine in 2003, and brought multiple successfully to the market. Today, millions of children and adults are immunized with these vaccines. Spicona’s immediate focus is the research and development of a novel, safe and protective COVID-19 vaccine. Spicona is headquartered in New York City, NY. For more information, visit www.spicona.com
About Catalent Biologics
Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx® cell line development technology, and manufactured 35+ commercially approved products. Catalent has recently acquired MaSTherCell, a technology-focused cell therapy development and manufacturing partner with expertise in autologous and allogeneic cell therapy that complements Catalent’s industry-leading expertise and commercial success in gene therapy development, manufacturing and adeno-associated virus (AAV) vector production. Together, Paragon Gene Therapy and MaSTherCell have produced over 100 GMP batches across 60+ clinical and commercial programs. For more information on Catalent Biologics, visit www.catalent.com/biologics
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,500 people, including over 2,400 scientists and technicians, at more than 40 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com
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