Developing new drugs is challenging, expensive and time-consuming, however, digital manufacturing techniques are delivering significant benefits without compromising on quality, as Eric Flynn, Head of Pharmaceuticals and Life Sciences at Siemens GB&I explains.
In recent years as the industry and regulators collaborated together to fight COVID-19, vaccines and antivirals sped through clinical trials and approvals in record time. For drug manufacturers on the whole, long-drawn-out timelines remain a real challenge, while the trial-and-error processes needed to launch a new product remain expensive and inefficient. However, advances in digitalisation technology are providing the platform for the sector to significantly speed up these processes through automation, by augmenting real-world testing with simulation.
As a highly regulated industry, pharma has an understandable tendency to be conservative in its adoption of new technologies. Despite the added difficulties of change, the opportunities for cost, efficiency, and speed improvements that modern manufacturing technology offers is clearly undeniable.
The promise of industry 4.0
In general terms, the fourth industrial revolution, often shortened to ‘Industry 4.0’, refers to the application of advanced digital technology and automation to drive optimisation of physical processes.
On the automation front, transitioning from batch to continuous manufacturing processes can deliver major productivity gains – so much so, in fact, that the FDA has said it promotes the development of these approaches in pharma manufacturing. In continuous processes, active ingredients are produced in compact, closed units, with a higher degree of automation and fewer manual interventions. Production steps that were previously performed sequentially are integrated and carried out without the need to re-set manually, removing much of the downtime. Automation is no longer something that is only an option for higher volume manufacturing. Smart biomanufacturing hardware has developed rapidly in recent years to the point where it is now viable for small-scale and single-use processes, too.
The other major aspect of industry 4.0 is digital modelling and simulation. Pharma manufacturing is highly ‘iterative’ in nature – identifying the exact composition of the drug and the process to manufacture it efficiently will always involve extensive trial and error to get to the most effective solution. In some cases, there is no realistic way to avoid carrying out the tests in the real world – some highly complex interactions between biochemical molecules, for example – although computational ‘in-silico’ drug testing is an area that is developing rapidly. However, there are also many parts of the process that can be effectively modelled digitally, allowing engineers to gain invaluable insight and reduce the need for real-world trial and error.
Scaling up production from small drug-discovery processes to commercial manufacturing is a key example. Using digital simulation and virtual prototyping can increase speed and reduce cost dramatically compared with traditional approaches, and the industry will need to adopt these technologies in order to bring products to market in reduced time.
Digital Twin
Arguably the ultimate frontier for digitalisation – where digital modelling is combined with monitoring, analysis and simulation.
By capturing real-time data, a digital twin reflects the operation of the process as it happens in reality, and is able to use that insight to simulate how it will perform when any of the operating conditions are changed. This means that, where once an engineer might have been turning physical dials – or at least making changes manually through a digital control system – this experimentation can now be carried out completely digitally. This grants the engineer increased oversight of the complex variables at play, allowing greater control over the outcome of the system. As a result, the laborious procedure of testing and measuring one small change at a time can be replaced by rapid testing of every possible permutation of a system to quickly identify the optimum conditions.
Integration between the digital twin and the actual machinery allows real-world and digital learning to be exchanged rapidly between the two, speeding up the engineering process at every stage. Digital twins can also improve regulatory compliance by ensuring that products are manufactured to the highest quality standards. By using simulation and testing, manufacturers can identify and fix potential issues before they appear in the physical production process. We are even beginning to see digital twins of key functions in the human body, allowing drug companies to predict how new products will impact patients. These advances promise to speed up clinical trials by augmenting them with digital insight.
A digital future
These approaches have undoubtable potential for pharma. At Siemens, we are seeing growing demand from businesses working across the supply chain for process digitalisation tools as they strive to make efficiency gains across the full end-to-end cycle of drug development.