Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, announced an expanded partnership with Janssen Pharmaceutica NV and Janssen Pharmaceuticals, Inc., two of the Janssen Pharmaceutical Companies of Johnson & Johnson, whereby Catalent Biologics will significantly increase the manufacturing capacity for large-scale commercial supply of Janssen’s COVID-19 vaccine at Catalent’s manufacturing facility in Anagni, Italy, including vial-filling, inspection, labeling, and packaging services.
Catalent and Janssen had previously agreed to dedicate an existing vial-filling line at the Anagni facility. As part of this expanded agreement, Catalent will accelerate the qualification and scale-up of an additional high-speed vial-filling line that is expected to be operational in the fourth quarter of 2021, to support the production of the Janssen vaccine through late 2022.
“We are pleased to expand our partnership with Janssen to support demand of its COVID-19 vaccine in Europe,” said Mario Gargiulo, President, Catalent Biologics, Europe. “Our global network of state-of-the-art biologics facilities, combined with our deep expertise in manufacturing scale-up and commercial launch, is well-suited to help provide a solution to this public health crisis.”
Catalent’s 28,000 square-meter (300,000 square-foot) facility in Anagni has a demonstrated track record in technical transfers and successful commercial product launches and offers extensive capabilities in aseptic liquid filling for biologics and sterile products across multiple vial sizes, and comprehensive primary and secondary packaging solutions, including serialization, to support product launches for oral solids, sterile, and biologics products. Catalent’s Switzerland affiliate serves as the principal for this contract, while Anagni will perform the manufacturing and packaging services. Similarly, Catalent’s Bloomington, Indiana, facility currently provides manufacturing and packaging services for Janssen’s COVID-19 vaccine supply chain in the United States.
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 Cell & Gene Therapy, a unit of Catalent Biologics, is a full-service partner for adeno-associated virus (AAV) vectors, lentiviral vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. When Catalent acquired MaSTherCell, it added expertise in autologous and allogeneic cell therapy development and manufacturing. Catalent Cell & Gene Therapy has worked with worked with industry-leading partners across 70+ clinical and commercial programs.
ABOUT CATALENT
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and 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 15,000 people, including approximately 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue.
