Opening the door to backroom biologics

Nature Biotechnology
Volume 37 Issue 10, October 2019
https://www.nature.com/nbt/volumes/37/issues/10

 

Editorial | 02 October 2019
Opening the door to backroom biologics
What would a world look like in which biohackers had access to automated drug-production platforms?
Open Access
… Biohackers are not the only ones chipping at the pharmaceutical monolith. Several medical centers are starting to produce limited batches of drugs for patients at the bedside through either magistral pharmacies or non-profit companies serving networks of participating hospitals. These initiatives are being driven by shortages in the supply of drugs and spiraling pharmaceutical prices. In the Netherlands, the University of Utrecht has established a network of hospitals capable of manufacturing and distributing magistral products across Europe and beyond. Similarly, in the United States, hospital systems such as Advocate Aurora Health are banding together and forming non-profit companies capable of manufacturing and distributing drugs for participating institutions. Commercial efforts in autologous chimeric antigen receptor (CAR) T-cell therapies have already moved the therapeutic frontier away from bulk to small-scale production.

Automated benchtop systems are beginning to integrate oligonucleotide synthesis and protein production. Last month, San Diego biotech SGI-DNA raised $25 million to invest in the global commercial launch of its BioXp 3200 system, an automated benchtop oligo-assembly platform for protein production, antibody library generation and cell engineering. Kilobaser advertises its portable, low-scale oligo synthesizer as the “Nespresso machine for DNA primers” for the research market.

Given economic pressures to innovate in drug manufacture and the potential of platform production technologies to enable decentralization, we may imagine a future in which the brand manufacturers’ monopoly on biologics could be broken. The first charge will come from biosimilar manufacturers. Small-scale magistral production for patients at the bedside would add a flanking maneuver. And biohacking might execute a final sharp pincer movement.

In such a scenario, biohackers could conceivably contribute by discovering new agents for the thousands of rare and ultra-rare diseases with no therapeutic options that drug companies dismiss because markets are too small. Contract services could provide pharmacokinetics and toxicology testing. And if automated production platforms become more widely available—perhaps in magistral production hubs—together with an adapted regulatory approval or registration system, biohackers might be able to plug their homebrew therapeutics into them.
This remains a thought experiment for now…