Recreating drug formulas for poorer countries

When drug companies make medicines, they initially protect them with a 20 year patent. Once that expires, anyone can make and sell the agent, but only if they know how to make it. And there’s no obligation on anyone to reveal that. So the problem is that many modern drugs - while highly effective - are based on things like antibodies, so they’re very complicated to make and often beyond the reach of the poorest countries. So what Natasa Skoko’s lab does is work out how these drugs can be made from first principles, and then teaches people from poorer countries how to make them. She showed me around…

Natasa - We are sitting in the lab where we produce biological drugs. Biological drug is a drug produced in living organisms like bacteria, yeast or mammalian cells. We are talking about insulin antibodies, different growth factors.

Chris - Most of the time when we're talking about drugs though, we're talking about pharmaceutical companies - 'Big Pharma'. You are a research laboratory, so how do you fit into the equation then?

Natasa - So we are a research lab who is working on the technologies to produce biological drugs, the same drugs that pharma companies produce today. So we are basically mimicking all the process in our lab to find this technology and to develop this technology in our own hands.

Chris - But why are you taking on big pharma? Because presumably they've got deeper pockets and better international networks for manufacturing and distribution and sales, et cetera. So where do you come in?

Natasa - Biological drugs are very expensive. So yes, this big pharma can produce it, but they also protect it for 20 years. So we wait until the patent expires and then everyone is free to produce it. We are trying to mimic all the processes to produce something as similar as possible to those biological drugs.

Chris - In essence then, you are reinventing the pharmaceutical wheel. They've done the hard graft of working out what works and they've tested it, and proved it's safe, it's then got an expired patent. But what people can't do, even though they know what the stuff is, is make it because that's the hard bit and that's where you come in.

Natasa - Exactly. The hard bit is actual processes and knowledge. So we need really deep knowledge into the process and no pharma company will open their books and show you. So this is where we come and we put all our knowledge and then make the process from the beginning to the end in the lab. Today we are now in the new facility, in the new lab that is a lab where we are trying to develop the process for the production of antibodies, monoclonal antibodies, because we all heard now the antibodies against the breast cancer for example, they made a revolution in the treatment of cancer patients. What's most important is that we transfer this knowledge to the local producers in least and middle income countries. So that means that they can come here, we can teach them good manufacturing standards. So they can be trained here for between four or six weeks they spend in our lab and we can teach them how to produce it.

Chris - So in the process of working out how to make really otherwise hard to make and expensive to make agents, you've also got a sort of training pathway. So you bring the people in, as well as giving people the knowledge in other countries, you're also giving them the pairs of hands type knowledge as well. So people go away armed with the skills as well as the piece of paper that says that's how you make that insulin or that breast cancer drug.

Natasa - There is a need in the world to have this bio manufacturing training hub. We train more than hundred people from 22 different countries and now they're able to produce and to bring the product to the local market.

Chris - That was one of the things that emerged during the COVID pandemic, wasn't it? Lack of on-the-ground manufacturing facilities and skilled people in lower income countries. So when you've trained these people, is there, critically, an infrastructure for them to go back to? Is there adequate on the ground facilities and provision of equipment, materials, et cetera so that those highly trained people taking away the recipes you are cooking up here can actually put this into practice in their own country?

Natasa - So we help them to do that. So we help them and teach them how to build this facility. But you know, even if you build a huge and nice facility, even if the government invests money into the building, there's an actual lack of trained professionals. So we really need to have a critical mass of people in these countries to be able to receive technology and reproduce the process.