Time for a new approach to drug development?
In his first Editor's Desk focus, Reece Armstrong asks whether it's time pharmaceutical manufacturers change their approaches to the way drugs are developed in response to changing healthcare needs around the world.
The pharmaceuticals industry is going to be around for a while. But whilst the industry might be indomitable, the need for change - a symptom of worldwide health pressures such as ageing populations and chronic health conditions - is ever present.
Take for example, the developments being made towards personalised medicine; medicines of which could change the very nature of how we treat disease. Scientists across the world have already shown that by analysing a person’s genome, we can better identify the types of diseases that can occur and be treated.
Indeed, here in the UK, health secretary Matt Hancock recently announced plans to extend the NHS’ 100,000 Genome Project to sequence one million genomes over the next five years. Hancock’s plans show clear ambitions towards bringing personalised medicines to the NHS and hopefully it can achieve the target: as it stands, the project only recently hit the 85,000 mark.
As the healthcare industry charges towards these new ways of treating disease, so too must manufacturers change aspects of their supply chain.
Historically, traditional batch processes have been used to manufacture large quantities of drugs but this “one-size-fits-all” approach cannot be applied to personalised medicines. Everything from harvesting and transporting patient cells to a manufacturing plant; ensuring an aseptic manufacturing process, freezing the batch, and of course transport, are critical steps to ensure the viability of the therapy.
That last factor might just be the most pertinent when we consider the variables that need to be put in place if personalised therapies are to reach patients. The shipping process, during which the stability of the product travels to a lab or a hospital is critical.
This is where new concepts and approaches to manufacturing start to become vitally important if the industry is to change to the needs of health populations.
One such approach - decentralised manufacturing - is being used to manufacture products that are in demand at a specific region. For pharmaceuticals, this could mean that if a patient requires a form of personalised medication, a manufacturing site situated closer to that particular hospital could produce it, reducing both transport time and any possibilities of contamination.
Now, researchers at the Massachusetts Industry Technology (MIT) have taken the idea of decentralised manufacturing and have applied it to biopharmaceuticals (1). The team has developed a compact manufacturing system, which as well being able to produce three different biopharmaceuticals, could also potentially produce personalised medicines.
The system, which can easily switch between producing different drugs, could enable a point-of-care approach from manufacturers to develop therapies for rare diseases and precision medicine. As it stands, such therapies are only needed in limited quantities, meaning manufacturers cannot dedicate production sites to such small quantities of drugs.
Throughout all this forward movement, one thing I hope doesn’t change is my position as European Pharmaceutical Manufacturer’s new editor. For the last couple of years, I’ve immersed myself in the life sciences industry and I’m excited to take the lead on this exciting publication.
References
http://news.mit.edu/2018/manufacture-small-batches-biopharmaceuticals-demand-1001