As healthcare providers move towards personalised medicine, manufacturers are beginning to rethink their process solutions. Evelyn Adams reports
Millions of people are taking medication that does nothing to treat their symptoms. Recent studies suggest many of the most popular drugs on the market help only a fraction of the people who use them. But this could be about to change.
Medicine is starting to get personal, and patients are increasingly demanding customised treatments with better results and fewer side effects. The trend has largely been driven by improvements in genome sequencing, which has become much cheaper and more effective. Storing huge amounts of data on health conditions has also become easier, and the world is far better connected on mobile platforms.
Combined, these factors are changing the way healthcare is delivered. “One major area of development is in companion diagnostics, which are used to identify the patients who will respond to a particular treatment,” said Richard Alldred, head of innovation at the Centre for Process Innovation (CPI). “A good example of the evolution of stratified therapies is in breast cancer treatment, where genetic data is being used to identify patient groups likely to respond to particular treatment regimens.”
The drive towards personal healthcare means the way medicines are being manufactured is also changing. There has been a shift away from creating small molecules to one in which treatments are a combination of small molecules and cell and gene therapies. To produce these personalised drugs cost effectively, engineers are looking at ways to replace inefficient large-scale batch production with investment in new technologies, such as continuous manufacturing.
Batch production and the centralised manufacturing systems are slow paced, inventory heavy and increasingly considered to be inflexible and unsustainable. What the industry needs now is a real-time demand-based supply chain. “Continuous manufacturing will undoubtedly be a major factor that can bring about change,” said Alldred. “It is likely to be the key to solving many of the manufacturing issues by enabling intensification, plant flexibility and improved control over product quality and characteristics.”
But some believe the manufacturing industry isn’t moving fast enough. “While demand for personalised medicines has increased fairly dramatically in recent years, when seen within the context of the entire healthcare market it is still in its infancy,” said Alan Johnston, pharmaceutical and life sciences business manager of Siemens. “Some of the industry’s processes would benefit from optimisation strategies as technology has moved on since they were originally designed.”
Alldred added: “The industry needs to find more efficient, cheaper and faster ways of discovering and developing new drugs and needs to find better and more flexible ways to manufacture successful treatments. A particular area that will need to be addressed is how an increasingly diverse portfolio of personalised and stratified therapies are regulated; current processes are not well suited to this.”
Johnston believes there are four key challenges in rolling out personalised medicine to the wider public; tackling efficiency issues during the production process; getting companies to be bold in introducing change within a highly regulated healthcare environment; dealing with the increased costs involved with personalised medicines; and introducing completely new process technologies.
He also believes continuous manufacturing may help address some of these challenges. “It can drive a marked increase in product quality consistency and help reduce both manufacturing costs and inventories,” said Johnston. “It also supports a sustainable, cleaner and more flexible process and can optimise capital costs such as reducing inventory. Finally, it supports real-time process analysis and product release, for instance through a ‘quality by design’ strategic approach.”
Manufacturers are beginning to adapt. For instance, research on continuous solid-dosage manufacturing has already been transferred from university-based research groups to the pharmaceutical industry. One project involves researchers at Rutgers, the State University of New Jersey, in the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), who have been working on a continuous direct compaction tableting process.
Industry is increasingly investing in the development of personalised and stratified therapies and adopting business models less reliant on the blockbuster drug mode
Richard Alldred, head of innovation at the Centre for Process Innovation (CPI)
The technology replaces the traditional multi-stage batch process by integrating feeders, mills, blenders and a press into a single process. Janssen Pharmaceutica constructed a line based on this design, to help speed up manufacturing for personlised drugs. And the trend is set to continue, according to Alldred. “The industry is increasingly investing in the development of personalised and stratified therapies and adopting business models less reliant on the blockbuster drug model.”
Some groups are looking towards technologies such as 3D printing to provide a solutions. Last year, the University of Central Lancashire (UCLan) filed a patent application for a system that uses a 3D printer to ‘print’ a tablet of medicine with realistic quantities that can be taken by a patient. The printer can replicate drugs already available in pharmacies and hospitals, but can also tailor medicines directly to an individual patient’s needs.
The future will see an explosion in the number and diversity of therapies available.
Dr Mohamed Albed Alhnan
This technology will potentially reduce the cost of manufacturing tablets for individual patients. Dr Mohamed Albed Alhnan from the School of Pharmacy and Biomedical Sciences alongside his team developed a drug-polymer filament system that can replace the original filaments in a 3D printer. The team discovered that the new pharmaceutical ‘ink’ allowed them to print a challenging tablet design with significant improvement of appearance and high accuracy of tablet weight and dose.
“In my view, the future will see an explosion in the number and diversity of therapies available. Many of these will have been developed for very specific, often small, patient cohorts,” said Alldred. “There will be a corresponding increase in the type of facilities used to manufacture medicines from large plants much like those of today to smaller, flexible units and even small-scale, fully enclosed, bench-top production units.
“A potential scenario will be that a patient attends a surgery, a number of rapid diagnostic tests are applied to determine the best treatment, which is then manufactured and formulated in a fully enclosed, small-scale manufacturing unit located close to the patient.” While a heavily regulated healthcare industry finds it harder to embrace change, Alldred believes the benefits of personalised medicines will spur more action in the coming years.