Novavax and J&J ink COVID-19 vaccine fill/finish deals

To support their COVID-19 vaccine candidates, Novavax has secured space at Endo’s facility and Johnson & Johnson has struck a deal with Grand River Aseptic Manufacturing (GRAM).

As Novavax progresses its COVID-19 vaccine candidate through the clinic, the firm has inked numerous deals with contract development and manufacturing organizations (CDMOs) to ensure it will be ready for large-scale production.

The latest focuses on the fill and finish of the Phase II candidate, NVX-CoV2373, with a deal in place with Par Sterile Products – a subsidiary of Endo International.

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NVX-CoV2373 is a potential vaccine against the COVID-19 consisting of a prefusion protein made using Novavax’ nanoparticle technology based on infecting Sf9 insect cells with baculovirus viral vectors that express the SARS-CoV-2 spike protein. The vaccine is also being tested with Novavax’ Matrix M adjuvant, a saponin-based adjuvant that acts in part by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in the local lymph nodes.

Par Sterile’s facility in Rochester, Michigan will initially make batches for a Phase III trial but will then   fill-finish the NVX-CoV2373 vaccine for commercial distribution in the US, if the candidate is approved.

“Our Rochester, Michigan facility has a long history of manufacturing critical vaccines and sterile injectable products for the US market and we are proud to partner with Novavax on such a critical initiative,” said Blaise Coleman, CEO of Endo. “This partnership further underscores Endo’s commitment to helping everyone we serve live their best life through the delivery of life-enhancing therapies”

Meanwhile, Johnson & Johnson, which recently initiated a Phase III trial for its recombinant protein candidate Ad26.COV2-S, has secured fill and finish capabilities at Grand Rapids, Michigan-based Grand River Aseptic Manufacturing (GRAM).

“The agreement includes the technical transfer and fill and finish manufacture of Johnson & Johnson’s SARS-CoV-2 vaccine candidate,” the CDMO said in a statement. “Together, teams from both companies are working diligently to transfer the manufacturing process to GRAM’s new, state-of-the-art facility, and are swiftly preparing for the start of vaccine production.”

The new GRAM facility opened in July and represents a $60 million recent expansion, which tripled the CDMO’s footprint.

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