New system speeds up biopharma production

04 October 2018

Researchers at Massachusetts Institute of Technology (MIT), US, have developed a portable drug manufacturing system that can make several different biopharmaceuticals to be used in precision medicine or to treat outbreaks in developing countries.
Georgina Hines

Biopharmaceuticals are drugs made up of proteins such as antibodies and hormones, and are produced in bioreactors using bacteria, yeast, or mammalian cells. They must be purified before use, so the process has dozens of steps and it can therefore take weeks or months to produce a batch.

Due to the complex nature of the process and its time restrictions, biopharmaceuticals are usually produced at large factories dedicated to a single drug – often one that can treat a wide range of patients.

To help supply smaller, more specific groups of patients with drugs, a group of researchers at MIT have developed a system that can be easily configured to produce three different pharmaceuticals – human growth factor, interferon alpha 2b and granulocyte colony-stimulating factor – all of a comparable quality to commercially available counterparts.

‘Traditional biomanufacturing relies on unique processes for each new molecule that is produced,’ said J Christopher Love, a Chemical Engineering Professor at MIT’s Koch Institute for Integrative Cancer Research. ‘We’ve demonstrated a single hardware configuration that can produce different recombinant proteins in a fully automated, hands-free manner.’

The system uses a strain of yeast called Pichia pastoris that produces proteins for biopharmaceuticals much faster than mammalian cells. The latter secretes up to 10 times more proteins so the purification process for drugs produced using mammalian cells is longer and more complex.

‘Our goal was to make the entire process automated, so once you set up our system, you press ‘go’ and then you come back a few days later and there’s purified, formulated drug waiting for you,’ said graduate student Laura Crowell who is one of the paper’s lead authors.

Although already portable, the team are now working to make the device small enough to be deployed to remote locations without large-scale drug production facilities. It is hoped the system can also be used during outbreaks in developing countries.

‘Instead of centralised manufacturing, you can move to decentralised manufacturing, so you can have a couple of systems in Africa, and then it’s easier to get those drugs to those patients rather than making everything in North America, shipping it there, and trying to keep it cold,’ said Crowell.

DOI: 10.1038/nbt.4262

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