The right levels of capacity, equipment, staff, and raw materials are key in scaling up COVID-19 vaccine manufacturing says Moderna, which is moving towards making one billion doses of its mRNA candidate.
Moderna Therapeutics’s mRNA-1273 is one of the frontrunners in the rush to develop a vaccine against COVID-19. The candidate is in Phase III trials and as such Moderna has focused much of its attention on building up its manufacturing capabilities to produce millions of doses, with a target of 500 million to be made in 2021.
“We know how to make 500 million doses next year. The team is very comfortable that they have a good line of sight to that,” CEO Stéphane Bancel told investors at the Morgan Stanley Annual Global Healthcare Conference this week.
The question, therefore, is how can Moderna get to the next milestone of one billion doses, something Bancel said involves four elements that the firm is working on.
“We have enough GMP space for a billion doses, that’s not an issue,” he said. The firm has a 200,000 square-foot manufacturing site in Norwood, Massachusetts – opened in July 2018 – but since accelerating its COVID-19 program, the firm has inked a deal with Lonza for commercial-scale production of the vaccine at the contract development and manufacturing organization’s (CDMO) sites in New Hampshire, US and Visp, Switzerland. CDMOs Catalent and Laboratorios Farmacéuticos Rovi have also been hired to support the candidate.
“You need capital equipment to make the product,” he said, adding that the firm’s stock of validated equipment coupled with orders recently confirmed by suppliers which are “literally in flight coming soon” places Moderna in a strong position.
“Then you have two more things left that you need to achieve to get to the finish line,” he continued. “One is people; we are very advanced in the recruitment of people. We’ve had incredible quality and numbers of people that have sent us resumes to apply for jobs. So, we also feel very good about our ability to get enough people to deliver 1 billion doses.
“The last piece is raw materials. So, as I said, we have a good line of sight to 500 million doses. What is not clear yet today is will we get on time all the raw material to get to 1 billion doses. So, of course, as time is going to go by, we would get more and more certainty about getting or not getting and what quantity we’re going to get.”
2020 and quality
For this year, manufacturing will likely be in the millions of doses, though Bancel would not give a specific number.
He also stressed the need for quality. “Quality is critical. We do not want to cut corners. We have to make sure we ship high-quality products that meet the highest spec of quality, and of course, FDA standards.”
His comments come a week after his firm was one of nine companies which announced a pledge to “uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines” – a response to political statements claiming a vaccine could be rushed through the regulatory procedures and perhaps to a COVID-19 vaccine being approved hastily in Russia.
The pledge states:
- Always make the safety and well-being of vaccinated individuals our top priority.
- Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
- Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
- Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
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