As a result, pharma has evolved as a risk-averse industry focused on getting a commercially viable product right, and then investing heavily in ensuring it is reliably mass-produced with no variations in quality or alterations to the original formulation.
It has also taken pharma decades to develop the manufacturing systems we have today, built to produce a limited number of high-volume, mass-market medications in large batches over weeks, months or maybe years.
But the sector is also incredibly competitive - and with only three in every 20,000 drugs making it to market, and of those only one probably making a profit – the need to be increasingly agile is imperative.
The ultimate goal is ‘batch size one’; highly personalised medications tailored to an individual’s specific biological, physiological and psychological profile.
And while we are a long way off from getting to that point, we are getting closer to the ‘mass customisation’ of common drugs. Advanced technologies are also driving the development of smart biopharma - organically-derived products bespoke to a patient’s genome makeup.
What’s making this possible is the advent of digitalisation, an operating model which offers pharmaceutical companies the combination of flexibility, communication and control they need to enable individualised production of personalised medicines at, ultimately, mass market cost.
Digitalisation is not just about more automation and more data analytics; it’s about embedding smarter, more responsive technologies across the entire process. From recipe generation and management, plant engineering, scheduling, production, quality control through to logistics.
It can impact at every level of the pharma manufacturing process. From large volume over-the counter drugs to highly personalised formulations for targeted therapies, and from biological to chemical processes, primary processing is as complex as it is diverse.
By embracing digitalisation, manufacturers can add real-time intelligence to the personal medication equation. It turns Big Data which is being generated across the factory floor into Smart Data, driving better informed decision-making using analytical software which can be shared across the entire value chain.
Digitalisation further enables informed decision-making on core operations such as scheduling production of a new medicine or maximising use of available assets – or even both simultaneously – while another benefit is identifying where capacity gains can be made and where downtime in minimised.
Many pharmaceutical companies are also now exploring how more joined-up production technologies can support modular manufacturing set-ups, providing the flexibility needed to produce smaller batches of customised products.
The modular approach uses plug-and-produce equipment, systems and processes which are quick and easy to configure, scale, and if necessary, relocate. They can also reduce production times, enable a smooth transition between different product batches and reduce the complexity associated with validation and sign off.
Of course, implementing any new or customised manufacturing techniques comes with risk, however slight. And even the smallest changes can open the door to unforeseen errors.
Another transformational impact on pharma manufacturing is the rise of the digital twin - a virtual replica or simulation that allows operators to visualise and test any aspect of the product and process.
Examples include simulating the design of experiments (DOE’s) and manufacturing recipes, which enables manufacturers to plan and test production processes in a safe, de-risked environment before going live.
Once embedded in the real-life production process, digital technologies can have a major role to play across every aspect of the pharma ecosystem.
Laboratory management, in terms of both safety and maximum process efficiencies, can be transformed.
Ingredient management can similarly be made smarter, with the ability to track all product and process data for raw materials. Procedures for verification within pre-set and carefully monitored thresholds can ensure your fermentation or synthesis processes get the correct ingredients at the right time and in the correct quantity and quality.
Process control can also benefit massively. For example, PAT (process analytical technology) to help to monitor and control your API process and capture all relevant data to achieve right-first-time quality.
Further, keeping your API isolated to ensure optimum yields through effective separation, purification and conditioning regimes is another key area where technology positively impacts.
For many pharma companies, digitalisation is still a nice-to-have’ rather than strategic imperative. It’s also not something that can be achieved overnight.
However, for businesses willing to combine a strategic commitment to digitalisation with a step-by-step approach to implementation, there is a world of new business opportunities waiting to be explored.
Alwyn Jones will be sharing more insights about the role of technology within the pharmaceutical industries at Siemens’ Digital Talks Conference in Liverpool on June 11th.
Also on the agenda will be Alfredo Ramos Plasencia, Healthcare Director at the Centre for Process Innovation, Dr Colin Clarke, Principal Investigator from The National Institute for Bioprocessing Research and Training (NIBRT), Andy Dwyer, Head of Clinical Packaging Operations, GlaxoSmithKline and Technology and Innovation lead for the Medicines Manufacturing Industry Partnership (MMIP)
More details at www.siemens.co.uk/digital-talks-2019