The New York Times wrote today in The Race for a Super-Antibody Against the Coronavirus about a network of scientists called Prometheus that is chasing the pandemic’s holy grail: an antibody that protects against not just the virus, but also related pathogens that may threaten humans. Prometheus is a collaboration between academic labs, the United States Army Medical Research Institute of Infectious Diseases, and a New Hampshire-based antibody company called Adimab.
This is a fascinating, amazing and innovative approach that holds tremendous promise, and is a great example of how this global crisis is spurring breakthroughs across many areas of medicine and bioscience. Alongside vaccines, it looks like an opportunity to become a big part of the long term solution.
Unlike the antibodies made by Regeneron and Eli Lilly, which fade in the body within weeks, Prometheus’s antibody aims to be effective for up to six months.
“A single dose goes a long way, meaning we can treat more people,” said Kartik Chandran, a virologist at Albert Einstein College of Medicine and the group’s leader.”
In mice and laboratory tests, Prometheus’s antibody protects against not just the coronavirus, but also the SARS virus and similar bat viruses — suggesting that the treatment may protect against any coronaviruses emerging in the future.The Race for a Super-Antibody Against the Coronavirus, New York Times, October 12, 2020
This blog is not about Prometheus – or vaccines – however. Rather, it about one of the concerns one of the questions and concerns raised in the article: the need to scale production capacity for antibodies. The search for ‘Super Antibodies’ and other magic bullets should get resources and funding. But we also must be investing now in the basic manufacturing capacity, raw materials and coordination that will enable us to scale the best mAbs as they are proven in trials.
What Capacity Is Needed, and How Can We Achieve That?
This issue brief from the Duke Margolis Center for Health Policy – COVID-19 Manufacturing for Monoclonal Antibodies – provides an excellent overview and set of recommendations for both what is needed, and what needs to be done. Specifically it provides:
- an estimate of the demand for mAb drug products (COVID-19 and otherwise);
- an overview of the manufacturing process for mAbs, and
- an analysis of manufacturing capacity currently in use to make mAbs for the North American and European markets.
The bottom line is this:
At current rates of infection, hospitalization, and symptomatic disease for COVID-19, and assuming only one dose is needed per patient, we estimate that over the next year hospitalized patients would require 0.26 million doses of neutralizing mAbs, non-hospitalized symptomatic patients 4.77 million doses, and people with close exposure to confirmed cases—defined conservatively as those in the same household as those who contract COVID19—would need over 20 million doses. With infection and hospitalization rates increasing in the United States and with forecasts of a much more significant burden in the fall, these numbers are only a lower bound for what the true demand might be when a drug becomes available.
Using mAbs as prophylaxis for frontline healthcare workers would further drive up demand. The number of frontline workers working with COVID-19 patients is unknown, but if we consider there are an estimated 13.8 million healthcare workers with direct patient contact, the potential prophylaxis use for them could rival or even exceed that of close patient contacts if more than one dose per healthcare worker were needed. Even if a substantial share of close contacts and health care workers are determined to be less likely to benefit from neutralizing antibody treatment, or if alternative prophylactics are available, demand is likely to be large relative to mAb manufacturing capacity.Duke Margolis Center for Health Policy – COVID-19 Manufacturing for Monoclonal Antibodies
The good news is that – while there are big challenges to surmount – the manufacturing capacity can rise to them – if we act now. Care must be taken to balance out the priorities of other mAbs, and the potential demand for COVID-19 mAbs versus total capacity is high. But at the same time, the brief also concludes that manufacturing capacity can be ramped up more rapidly for mAbs then vaccines.
The brief emphasizes that the Federal government can play a critical role in 3 areas:
1. capital investment – or covering the risks of these – to ramp production;
2. coordination of supplies and production with existing facilities – as Operation Warp Speed is doing now for vaccines; and
3. expand manufacturing on a relatively short timeframe using replicate single-use modular platforms or by identifying and bringing online mothballed facilities
They summarize as follows:
Considerable policy attention has focused on advance planning for manufacturing capacity for vaccines. This issue brief suggests that although mAbs and other potential COVID-19 therapeutics do not require as much advance planning or vaccine-level manufacturing scale, additional policy attention is needed now to assure that shortages will not emerge as more therapeutics demonstrate effectiveness against the pandemic.Duke Margolis Center for Health Policy – COVID-19 Manufacturing for Monoclonal Antibodies
Given the vast cost in lives, treasure and disruption to our economy, increases in investment needed to scale production of mAbs are trivial – and grossly underserved. This country can and must put focus, attention and resources into scaling production capacity for the short and long term for this powerful tool set in the battle against COVID-19 – and all of the future Coronavirus cousins and hitherto unknown viruses to come.