I’ve found that the excitement generated by cell, gene and tissue-based therapies can obscure the fact that small molecule drugs are very much still with us and continue to play a huge role in the modern medicinal arsenal.
Discovery of suitable new drugs is a big part of that activity but, as one of my former bosses used to point out, the unsung heroes of medicines innovation are the people that have to ensure that the whole product (drug, formulation, package, instructions) can reach the patient in an effective form and for the right price: the development teams.
Have we exhausted the use of small molecule drugs?
I sometimes hear scientists say about small-molecule drugs that all the low-hanging fruit have been picked, or words to that effect. There are only so many structural variants for an organic molecule, they argue, and we will exhaust the possibilities soon. When we do, we must concentrate our efforts to proteins and cells. Which is rather like saying that there will soon be no music because all the tunes will be used up. In fact about 90% of current medicines are based on small molecules.
This might be expected because of established products. More surprising is that at least 50% of new drugs will continue to be small molecules, at least for the foreseeable future.
Target molecule synthesis
Synthesising the target molecule is only half the story. The development of a manufacturing process for a new small-molecule drug can be thought of as two topics:
- The manufacture of the active pharmaceutical ingredient (API): the component that causes the desired effect in the patient.
- The inclusion of the API in the dosage form: the object that allows the API to enter the patient’s system. Dosage forms such as tablets, ampoules for injection or inhalers are familiar products.
Although there is also a third component:
- The way the system works to get the medicine to the patient: The impact of digital technology, just-in-time delivery and switching from making to stock, (I make it, I send it to you, you put it in a cupboard and wait until you need it), to making to order (you tell me when and where you need it and I create it to meet that order) are all ways of sharpening up the way that medicinal products are made and used.
Trends in UK Medicine
There are some trends in UK medicines manufacture that will determine how effectively we are able to develop and market new medicines.
- There is a pressure to reduce prices and to provide more effective medicines (no surprises there).
- Less obvious is the tendency towards personalisation (dosage forms specific to the individual patient e.g. containing a pre-measured dose or supplied with a customised device to be used when administering).
- Another trend is the tendency towards postponed manufacture i.e. the ability to store intermediates such as the API and to make the dosage form on demand to the required specification.
Both of these trends mean that the average batch size of the dosage form in the future will decrease and the number of product variants will increase.
Economies of scope not scale
The industry is seeking to reduce waste, which aligns with the idea of making to order as in personalised medicines above, but also means avoiding failed batches. Making medicinal products is becoming less craft dependent and companies are adopting principles of design for manufacture similar to those from the automotive industry: production more like the six-sigma approach.
The industry needs less economy of scale (big batches from big facilities) and more economy of scope (access at reasonable cost to adaptable plant at smaller scale and expertise to meet the demands above).
So it’s good to know that over the last three years or so a consortium of pharma companies made the case for UK investment in extra and advanced facilities to meet these trends. The result is the Medicines Manufacturing Innovation Centre (MMIC).
The Medicines Manufacturing Innovation Centre (MMIC)
I went along to the public announcement in Glasgow last Friday to represent Innovate UK because of our role in delivering funding of £13m from UK government’s Industrial Strategy Challenge Fund (ISCF) to the MMIC project.
The announcement was made at the University of Strathclyde’s Centre for Continuous Manufacturing and Crystallisation (CMAC) by Lord Duncan (Parliamentary Under Secretary of State for Scotland) and Paul Wheelhouse (the Scottish Government Minister for Business, Innovation and Energy).
Professor Alastair Florence led a tour of the current facilities at CMAC and the current kit is very impressive, let alone the forthcoming developments. Continuous reactors, capable of manufacture on demand while occupying a small space, were prominent and I recognised some of the equipment that I used in the past for batch processes but with an enviable modern array of sensors and digital controls.
The thing that struck me most about the event was the positive, can-do feeling among the delegates and the sense of excitement that the UK is embarking on something major, unique and likely to punch above its weight in international markets.
Location of MMIC
The chosen site for the MMIC is in Renfrewshire, close to Glasgow airport and near the National Manufacturing Institute for Scotland (NMIS). This places it within the Advanced Manufacturing Innovation District, Scotland. The region is able to supply logistics resources and manufacturing talent.
Delivering a step-change for the UK
The MMIC will deliver a step-change in the capability and capacity of the UK in the manufacture of small-molecule medicines. GSK and AstraZeneca have each shown their commitment to the venture through direct funding (£7m each) and sent representatives (Dave Tudor and Jon Paul Sherlock respectively) to the announcement event.
Major public sector investment from Scottish Enterprise (£15m) will enable work to begin with confidence. The Project will be led by the Centre for Process Innovation (CPI, a part of the Catapult Network funded by Innovate UK) and the University of Strathclyde.
The early stages of the Project will see design-and-build work advancing in parallel with R&D at the University of Strathclyde. Over the next three years a portfolio of activity will be built up aimed at equipping UK-based business with tools and techniques to meet the needs of patients and commerce in the 21st Century.
I look forward to sharing the news as it becomes available.
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