As Moderna Therapeutics is on the verge of conducting its Phase III clinical trial for its coronavirus vaccine candidate, mRNA-1273, it has teamed up with Catalent, a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies, and consumer health products.
Moderna collaborated with Catalent to boost the filling, manufacturing, and packaging capacity of its vaccine candidate.
In May, Moderna signed a 10-year collaboration with Lonza, Swiss multinational, chemicals, and biotechnology company, for large-scale manufacturing of the vaccine.
As part of the latest deal, Catalent has plans to deliver an initial 100 million doses for the US market beginning in the third quarter of this year. Also, it will provide clinical supply services that include packaging, labeling, storage, and distribution in the Phase III clinical trial.
Chief Technical Operations and Quality Officer of Moderna Juan Andres said, “We appreciate this collaboration with Catalent and the flexibility of their team to deliver critical fill-finish capacity for mRNA-1273 at unprecedented speed. It has been wonderful to see both teams working together to support the common good.”
Catalent CEO John Chiminski said, “Catalent is proud to partner with Moderna in its work to address this critical public health need.”
“Catalent’s proven expertise in manufacturing scale-up and commercial production are well suited to support Moderna’s efforts to prepare for a wide-scale supply of this vaccine candidate so that it is available if appropriate to address the pandemic,” he added.
Globally, more than dozens of vaccine candidates have been undergoing trials, and Moderna’s mRNA-1273 has almost reached its final stage of trials after showing promising results in Phase I and Phase II trials.
The Phase III clinical trial of mRNA-1273 typically will enroll about 30,000 participants in the United States.
If found successful in the final stage of the trial, Moderna believes it could deliver more than 500 million doses a year, and up to 1 billion doses a year starting in 2021.
Chief Medical Officer of Moderna Tal Zaks said, “We look forward to beginning our Phase III study of mRNA-1273 with some 30,000 participants in July.” “Moderna is committed to advancing the clinical development of mRNA-1273 as safely and quickly as possible to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease,” he added.
