Earlier this year, it was announced that the government was investing £100 million in a new facility in Braintree, Essex, with the capacity to produce enough vaccine to protect the UK population from COVID-19. As the UK enters a second lockdown, it’s a sobering reminder that the possibility of a world-wide pandemic is never far away. With so much at stake, Rod Schregardus from The Access Group believes its production team will need to use advanced manufacturing planning and scheduling methods to maximise its potential. Here, he tells us why.
The last few months have proved that we, as an industry, need to stay one step ahead. We need to prepare for future outbreaks as well as the one we’re dealing with now. Urbanisation, destruction of natural habitats, global travel and the illegal wildlife trade can all contribute to the spread of novel viruses in human populations.
Currently, there are more than 170 separate research teams working on a COVID-19 vaccine and seven candidates are already in large-scale efficacy trials. Now, with investment in the new Cell and Gene Therapy Catapult Manufacturing Innovation Centre in Braintree, the UK is set to ‘accelerate the mass production of a successful COVID-19 vaccine in the UK’ and deliver ‘millions of doses’ per month.
The announcement has brought to the fore long-standing questions about manufacturing planning and capacity, especially given that the processes are new and highly-complex. At present, there is no approved recipe for a vaccine – so we don’t yet know how long it will take to produce even a single batch (it could be six weeks, it could be 36). Meeting the ambitious targets set out, when there are still so many unknowns, demands a flexible approach to planning that optimises production at every step.
Whatever investment is made in state-of-the-art equipment and skills (and note that the government has also pledged £4.7million in the Centres for Advanced Therapies Training and Skills) should be matched by similar investment in digital technology to support optimal scheduling.
Poor scheduling processes mean that any pharmaceuticals manufacturer, regardless of whether they are producing a COVID-19 vaccine, will struggle to scale up successfully, or introduce new products.
Though time-consuming, it’s possible to use spreadsheets to create a production plan even when scheduling hundreds of inter-dependent tasks in sequence. But it would be near-impossible to rely on them at this scale and, given the critical nature of the work, it would not be a good use of resources either.
Advanced planning and scheduling (APS), on the other hand, enables planners to understand and maximise capacity in any facility, including one that is not yet operational. Powered by real-time production data, it offers clear insights with a level of granularity that far surpasses spreadsheets.
This is important because, without complete visibility of every process, planners cannot see where there is capacity to ramp up production, nor can they identify and resolve any potential issues quickly.
But finite capacity scheduling and using a central and standardised dataset means they’re able to make swift and effective decisions, while also lessening the chance of a costly mistake or delay. Ironing out even small inefficiencies could reduce lead times too, making the vaccine available sooner. It’s about striking a balance between ensuring all resources (staff and equipment) are fully utilised, without overloading the schedule and causing bottlenecks or failing to factor in machine maintenance.
As well as day-to-day scheduling, planners should be able to model different scenarios on a large-scale, in line with their resources and constraints, and understand the impact of every decision before it is made. Working alongside project managers, their data-led insights can determine whether the facility has capacity to produce the vaccine and give stakeholders confidence that their investment will deliver the returns they want.
Ready to adapt
As mentioned previously, the manufacturing planning and processes involved in COVID-19 vaccine production are still unknown and there is no blueprint to follow. Planners must therefore be ready to adjust their master schedule when production begins, taking into account any new opportunities or constraints that arise. This will enable them to get the most from their resources and ultimately deliver the required dose of vaccine in the shortest amount of time.
By investing in new training facilities, the government has demonstrated its commitment to the long-term future of the cell and gene therapy sector, which is expected to support more than 6,000 jobs by 2024. With half of these in manufacturing and bioprocessing, this is an opportunity to instil good practices from the start and set the standard for other sites in the future.
Clear and actionable manufacturing planning and scheduling processes are one of the hallmarks of a successful production team and can be implemented using a dynamic cloud-based schedule. As a result, time is not lost duplicating tasks unnecessarily, reporting is consistent, and teams are able to collaborate and share best practice, wherever they are based.
It is still too early to know how the pharma industry will change as a result of developing and delivering a COVID-19 vaccine and treatment. Increasing capacity at speed is a gamble, even with government support and outside these extraordinary circumstances, we’re unlikely to see anything like this again.
But demand for new and innovative therapies means that expansion is on the horizon for many companies. Getting drugs to market sooner not only improves health outcomes for patients but also ensures that investment in new facilities, equipment and skills, as well as R&D, pays off. Experts should therefore be channelling their experience into refining the schedule to ensure that orders are completed on-time, in-full, without delays, wastage or rejects.
In recent years, we have seen the impact of diseases such as Ebola, SARS, MERS – but it is as a result of the COVID-19 pandemic that the UK has moved quickly to bolster its manufacturing capabilities, as well as investing in skills and training and R&D.
Rapid modelling and ‘what-if’ analysis should reassure stakeholders that new facilities, like the one in Braintree, have the capacity to deliver innovative new treatments that help to advance modern medicine. Once it is fully operational, planners need the right tools to create dynamic data-driven schedules that make the most of resources and capacity, without ever compromising quality.