• Question: What is the process for making a drug- from an idea all the way to production and civilian use?

    Asked by anon-258247 on 9 Jul 2020.
    • Photo: Heather Walton

      Heather Walton answered on 9 Jul 2020:

      Great question – it is a very long process and will include the work of lots of people, and costs a lot of money! There will be medicinal chemists here who can answer this better but in my understanding the stages are:

      Deciding on the molecule to use – this can take a long long time and involves a lot of work but I am going to say that that’s what your ‘idea’ is, because I know nothing about it!
      Deciding on the route to make your molecule – making sure it is efficient and you don’t get any unwanted side products
      Testing to check the product from your route is safe – this is generally animal testing
      Formulation – making the drug into a form where it can actually be taken e.g. a tablet, injection
      Clinical trials – there are 3 stages of this, each of which uses more patients and sometimes healthy volunteers, and the safety and effectiveness of the drug are tested
      Developing manufacture – This has to happen at the same time as the clinical trials or even before, figuring out how to make large amounts of the drug and get it into the formulation in a factory, meeting all quality and safety requirements and also being as cheap and environmentally friendly as possible (massive job!) While the stage 1 clinical trial might not need the drug to be mass produced, a stage 3 definitely would!

      After that you have a drug but the journey is not over, it must be approved by regulators to be used in different places (e.g USA, Europe, UK) and even after that must be marketed/advertised to show how it is better than competitors or old alternatives. Further data on performance, safety and side effects is also gathered even after the drug is in use.
      Once a drug has been approved and is in use, changes to the formulation, manufacturing, and even the route of synthesis can be made, but this will require a huge amount of work to check that is does not have an adverse effect on the final product!

    • Photo: Katherine Haxton

      Katherine Haxton answered on 10 Jul 2020:

      Heather’s already given a great answer to this but there’s an interesting step between deciding which molecule to use and getting it into clinical trials: how we can make the molecule on a really big scale. When chemists design the ways to make molecules in the lab, they are doing it on a really small scale – less than a gram at a time. And they use experiments that work at that scale. To make enough of a molecule, it will have to be made on a much bigger scale, more than a kilogram at a time and probably even bigger than that. Some of the experiments we do in the lab don’t work as well on such big scales, and if they need to use very dangerous chemicals, that’s very risky on a big scale. The development of some drug molecules was stopped because they couldn’t be made in a big enough quantity. This problem is solved by chemists interested in process chemistry, and also by chemical engineers who build the equipment to make chemicals on a bigger scale.

    • Photo: Sebastian Cosgrove

      Sebastian Cosgrove answered on 14 Jul 2020:

      The answers by Heather and Katherine are both really good and detailed, and give a really good idea of the whole process!
      One part Heather mentioned is deciding on the molecule to make. This is actually a really active area of research as a lot of the drugs we do make come from a limited number of chemical reactions, which means lots of drugs look similar to each other. The problem with this is that the protein structures of diseases are extremely complex and diverse, and new diseases are emerging all the time (COVID-19 for example), so this means we need to have as many different types of chemical structures as possible to test against new diseases.
      One way to do this is to design new ways of doing chemistry, so coming up with new chemical reactions. The interesting point here is lots of chemists will invent new chemical reactions without ever thinking about making a new drug. They invent new reactions and let other chemists think about how to use these new reactions to make new drug compounds. I think the process of drug discovery really underlines the importance of scientists all working together in big teams to make sure we can solve important problems together. If you think about all the stages that Heather has described, they will all involve big teams working together and in the end will produce one drug! Collaboration is key for success in science!