By: Nigel Whittle, Head of Medical and Healthcare a Plextek Ltd Last Friday Donald Trump was treated with an antibody cocktail made by the biotech company Regeneron. His recovery has prompted him to call for the drug to be made available to all US citizens through an Emergency Use Authorization. However, the safety and effectiveness of the drug have not yet been proven, and there is no way for the President or his doctors to know that the drug had any effect as most people recover from COVID-19. As the Metro states today: “Trump is just one of 10 people receiving the drug, which is still in the experimental phase and is intended to boost antibodies to fight the infection”. Is it logistically possible to fulfil Trump’s statement and take a drug from small scale testing to Nationwide rollout? In this blog, we unravel a bit of the situation.
What are the options?
There are over 70 different antibody treatments for COVID-19 currently under investigation. In contrast to convalescent serum, monoclonal antibodies (in this case a pair of antibodies developed by Regeneron) are targeted precisely at the spike protein of SARS-CoV-2. This approach makes good scientific sense and there are real hopes that it will be effective. Already several groups have published data showing that this biologic treatment can reduce the virus load in the body as well as the time it takes for patients to recover. However, the evidence in patients is very limited and these treatments are still classed as experimental drugs while clinical trials are ongoing.
The development of these types of novel biologics starts with the creation of cells that produce therapeutic antibodies. Through the process of cell expansion, sufficient quantities of cells are then manufactured to supply enough antibodies for testing and support of Phase 2 and 3 clinical trials.
How to scale up?
There are significant challenges with rolling out new biologic drugs, aside from the obvious health risks. Rapidly manufacturing medicine requires physical infrastructure in laboratories, supportive mechanics, bioreactor vessels, filling, packaging and a distribution method.
Stephen Guy, Principal Consultant for Life Sciences states, “Both flask-based and bioreactor technologies are commonly employed for cell expansion, and often the choice depends on the type of cells used. Either way, the physical task of ramping up the production process needs many multiples of any technology and a laboratory supplier list that can fulfill requirements.”
In partnership with Design Momentum, we have been exploring the technology behind new collaborative robots that can automate and semi-automate many of the manual processes presently involved in cell expansion. In addition to speeding up laboratory processes, the robots will remove the difficulties of manually handling heavy consumables during seeding and harvesting. Antibody medicines are exciting in their potential to create novel therapeutics and we are keen to support this endeavour with our innovative technology.
As others have noted, there is a strong argument that it is both bad medicine and bad ethics to give unproven drugs to influential people, when they have not been through appropriate randomised clinical trials. Already people are contacting Regeneron asking to be included in the clinical trials of the drug, and it will be very hard for the FDA to resist calls to fast-track the drug into widespread use. It is worth noting that the Trump administration and Regeneron recently agreed to a $450 million deal to manufacture the drug for public use if Regeneron can get either emergency or full FDA approval.
It is easy to express a desire for something to be done, but the hard work is in the implementation. Investment in new laboratory techniques is required to enable efficient deployment to the general public at scale and within timeframes set by our politicians.
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