‘Magic bullets’ for all: democratising biologics by rethinking antibody development, manufacturing and delivery
Antibody therapeutics revolutionised how diseases like cancer are treated in the developed world, but their high manufacturing cost and cumbersome distribution and administration leave them out of reach for most. In this guest article, Lumen Bioscience’s CEO, Brian Finrow, and EVP of Production & Development, Craig Behnke, discuss how new technologies are making mass-market antibody drugs feasible for ultra-prevalent diseases like COVID-19 for the first time.
CHO manufacturing: scaling impossible heights
Antibody drugs have revolutionised several medical fields since breakthroughs in bioengineering in the 1980s enabled them to be manufactured monoclonally through Chinese hamster ovary (CHO) cell fermentation. Yet, so far they have not achieved their full theoretical potential. Almost all US Food and Drug Administration (FDA) approvals to date have been for diseases with lower worldwide prevalence; in particular, for oncology treatments and autoimmune disease in the developed world. They have not had a big impact on widespread health issues like the COVID-19 pandemic.
A key reason is the extreme lack of manufacturing capacity. According to industrial data provider BDO, global manufacturing capacity currently stands at approximately just 24,000kg/year.1 Even if 100 percent of that capacity were diverted to Regeneron’s anti-COVID-19 antibody cocktail – which is dosed at 1.2g per patient – that is just 20 million doses per year. Other estimates of underutilised CHO capacity are sometimes higher,2 but even assuming 10-times greater production, this is miniscule compared to a global population of eight billion.
Worse, because the serum half-life of injected antibody drugs is usually around one month, prophylactic use for diseases like COVID-19 would likely require monthly dosing, increasing demand to hundreds of millions of doses or more. Building a new CHO antibody plant costs upwards of $1 billion and two to three years, thus scaling up production to this degree is unfeasible. Furthermore, all antibody drugs currently on the market are delivered by injection, which requires rigorous purification protocols, further increasing the cost and scaling challenges.
Given this, it is not surprising that antibody drugs have not played a large role in the COVID-19 pandemic.