Moderna Therapeutics believes its Norwood, Massachusetts manufacturing plant is a “competitive strategic advantage†in the race to develop and scale-up a vaccine against COVID-19.
Moderna released data from a small Phase I study of its candidate mRNA-1273 yesterday. The trial, conducted by the National Institute of Allergy and Infectious Diseases, showed signs that the candidate elicits antibodies at levels comparable to those found in the blood of dozens of patients who have recovered from COVID-19, caused by the novel coronavirus (SARS-CoV-2).
Now the firm says a Phase II study enrolling hundreds of patients is expected to begin “shortly,†and a Phase III study enrolling thousands is planned to start in July, making it the frontrunner in the race to develop a vaccine against the infectious disease.
Image: iStock/cacaroot
According to CEO Stéphane Bancel, Moderna’s manufacturing strategy – and specifically its inhouse facility in Norwood, Massachusetts – played a major part in the speed of development and will help expedite the candidate’s progression through the clinic and beyond, helping the firm achieve its goal of producing a billion doses a year.
“I believe it is a competitive strategic advantage of a company, having our own manufacturing facility from raw materials to shipping vials to clinical trials,†he told stakeholders during a conference call yesterday.
If Moderna had been forced to use contract development and manufacturing organizations (CDMOs), “we could never have been so fast,†he continued, adding that while four or five companies could make the mRNA for the firm, there would have been delays in waiting for empty slots and tech transfers, as well as losing on Moderna’s own determination to expedite this project.
“Being in Norwood, with our own team on equipment, on facility, allows us to tell the team this is very important; this one needs to move through the system much faster than usual, and people knew the importance of this as virus was spreading, all determination just grew stronger with the day.â€
Norwood and Lonza
The 200,000 square-foot Norwood site, which opened in July 2018, has capacity to develop materials for preclinical toxicology studies, Phase I and II clinical development programs, and the ability to manufacture, test and run fill/finish operations for its mRNA development candidates.
Thus to scale-up mRNA-1273, Moderna has also inked a deal with Lonza with initial manufacturing planned to take place at the CDMO’s site in Portsmouth, New Hampshire, with a second phase planned at its site in Visp, Switzerland.
“The partnership with Lonza helps to be able, assuming a 50-microgram dose, to potentially get to one billion dose per year,†said Bancel. The deal will increase capacity ten-fold for the COVID candidate, though Bancel suggested the firm would have preferred to have done all the production inhouse, if it had the option.
“Many of us wished we already had a big manufacturing plant where we could have been able to make 20 million or 50 million doses in a first month from January; that could have been amazing. Unfortunately, this caught us a bit too early in Company’s history.â€
Any in-house production facility is an advantage – of course. It is obvious – and has been throughout history – that any degree of vertical integration on an immediately local, physical basis provides a large benefit – when it is valued in hindsight, during a crisis.
But there is no good method for assigning a dollar-value to the intangible benefit of having that facility immediately available (and so empty and waiting at all other times – possibly for years when there is not need for it), or to the equally intangible liabilities of delay and inconvenience of dealing with a third-party, especially one several time zones distant. This is completely missing from current methods of cost-assessment and IRR or ROI calculations.
We need a method of valuing high advantage/low use assets and the avoidance of crisis, as well as the disadvantage of constant-but-trivial inconvenience and delay in day-to-day operations. At present, we seem to be unable to do this.
The intangible value of contingency, flexibility, redundancy, and robustness have been the casualties of the last few decades of cost-savings.