Lonza Teams up with Moderna on Covid-19 Vaccine

04.05.2020 - Swiss fine chemicals producer and CDMO Lonza has signed a 10-year worldwide strategic collaboration agreement with Cambridge, Massachusetts-based US biotech Moderna to enable larger scale manufacture of Moderna’s RNA-1273 based Covid-19 vaccine candidate as well as other of products in future.

Under the terms of the agreement, the two companies plan to establish manufacturing suites at Lonza’s facilities in the US and Switzerland and will eventually produce the mRNA-1273 vaccine at both sites. Technology transfer is expected to begin next month, with the first batches to be produced at the Swiss company’s US site beginning in July.

“Over time,” Lonza said, the partners plan to establish additional production suites across the CDMO’s worldwide facilities, ultimately enabling production of the material equivalent of up to 1 billion doses of mRNA-1273 per year for use worldwide, assuming the currently expected dose of 50 µg.

The Basel-based company said its facilities complement Moderna’s US manufacturing efforts, which continue to be ramped up to prepare for the further clinical development and commercialization of mRNA-1273.

An undisclosed part of the funding for building up manufacturing operations at Lonza in the US will be covered by Moderna’s contract with Biomedical Advanced Research and Development Authority (BARDA).

To accelerate development of mRNA-1273, the US preparedness agency, which will support late-stage clinical development programs of mRNA-1273, is making $483 million available to fund development of the vaccine through to FDA licensure and manufacturing.

Lonza’s experience in scaling manufacturing of innovative medicines, including support for more than 50 commercial approvals across regulatory jurisdictions, will support Moderna for global supply, the Swiss company said.

Moderna’s vaccine candidate was developed in conjunction with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). At the end of April, the firm announced it had submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for phase 2 and late stage studies of mRNA-1273, if supported by safety data from the phase 1 study.

Most recently, Moderna announced that its NIH-led phase 1 study had completed enrollment of three dose cohorts (25 µg, 100 µg and 250 µg) at Emory University in Atlanta, Georgia, and is expanding to an additional six cohorts of older adults and elderly adults.

Commenting on the collaboration with Lonza, Moderna’s CEO, Stéphane Bancel, said this will accelerate tenfold the biotech’s manufacturing capacity for mRNA-1273 and other clinical products. Moreover, he said, “Lonza’s global presence and expertise are critical as we scale at unprecedented speed.”

Albert M. Baehny, chairman and CEO ad interim at Lonza, said his company is “fully committed” to leveraging its global network and experience in manufacturing technologies to support Moderna.