With the target set to offer a COVID-19 vaccine to a further 17.7 million people in the next five priority groups – including all over-50s – by the end of April, the UK’s vaccine minister, Nadhim Zahawi appears confident that ‘lumpy and bumpy’ supply chain issues can be ironed out. So how exactly can pharma companies increase capacity and deliver the required number of doses to market?
Having achieved the remarkable feat of developing a vaccine within a year of a major pandemic taking hold, both AstraZeneca and Pfizer came under fire for reducing initial deliveries to the European Union (EU). However, it is important to remember that they have been working in the most extraordinary circumstances – producing a vaccine in anticipation of approval, at scale and involving new and complex production processes. Not only have they been quick to respond to the changing situation, they have also demonstrated they have plans in place to ensure the vaccine can be delivered over the long-term.
Away from politics, the drug companies are clearly taking steps to make process improvements at speed. It should be a case of short-term pain for long-term gain for Pfizer as it upgrades its plant in Puurs, Belgium, putting the company on track to deliver two billion COVID-19 vaccine doses in 2021.
Meanwhile, the lower-than-expected supplies of the Oxford/AstraZeneca vaccine (attributed to ‘variability of yield’ at different sites) only underlines the challenges teams face when managing new production methods and working to tight deadlines. The company’s CEO Pascal Soriot made the point that processes that previously would have taken years to develop and refine, now had to be established in just a few months.
How can pharma companies increase capacity and deliver the required number of doses?From a manufacturing perspective, there are three options:
- Contract out the work
- Build or upgrade plants
- Make better use of what they’ve got.
Manufacturers have already formed strategic partnerships to deliver the vaccine through sub-contracting. Novartis, for instance, is supporting production of the Pfizer/BioNTech vaccine, while Valneva is working with biopharmaceutical firm Dynavax but there might be scope to use more sites across Europe.
Increasing capacity, by building new plants or improving existing ones as Pfizer is doing, provides a long-term solution to high and continuing demand.
Given the level of investment required in a capital project of this nature, it’s vital that the risks are off-set with detailed capacity analysis to establish whether a proposed facility can deliver on its objectives.
Using data from previous batch runs (including product cycle times), capacity models can be created using advanced planning and scheduling software. Well before COVID-19, our technology was deployed by a major US firm planning a $1billion vaccine facility in preparation for a possible flu pandemic.
Their capacity model, built in less than two weeks, meant every process underwent rigorous analysis before production even began. Ten areas for remediation were identified and ranked – leading to process improvements that meant the facility could speed up delivery by as much as three weeks and provide reassurances to stakeholders.
While large-scale projects take time to deliver results, manufacturers can increase capacity and maximise batch yield relatively quickly with a disciplined approach to day-to-day planning and scheduling.
By automating the task, using an unlimited number of planning algorithms, production teams benefit from a dynamic and optimal schedule that allows them to maximise yield, while maintaining the validated process.
Given that a single batch might have as many as 1,000 operations, and processes do not follow a linear sequence, automation makes planning easier and more precise. Providing actionable insights, it supports better resource planning so that tasks can be completed concurrently, therefore compressing the overall batch footprint. Moreover, planners are able to identify any under-utilised capacity, in the bio-reactors for example, and opportunities to share resources to speed up production.
Another biopharma company we worked with replaced spreadsheets with advanced planning and scheduling software, which enabled them to identify issues, such as bottlenecks and increase capacity. By the end of a 12-month optimisation programme, the plant had achieved 20% faster through-put without investing in additional resources.
In a fast-moving situation like this, visibility of every action and process is paramount. When teams are working 24-hours a day, communicating the latest plan and actions via a shared planning platform will ensure there are no unnecessary hold-ups, nor lengthy handovers. In other words, it promotes a spirit of collaboration that is difficult to achieve when people are working from spreadsheets and instils confidence that the production data is up-to-date and correct.
While the Covid-19 vaccine programme has yet to be rolled out fully, it has created a blueprint for future pandemic responses and, hopefully, provide reassurances that the UK life sciences industry could once again move quickly if we faced a similar crisis. Programmes, provided by companies such as Cell and Gene Therapy Catapult, give us reasons to be optimistic about innovation in drug development and delivery, beyond the current crisis.
Lean production methods
Looking ahead, there are clear commercial benefits to lean production methods, especially given the high costs of R&D. To cite one final example, our technology helped a North Carolina biopharma company to move away from spreadsheets and flipboards and increase capacity to raise the number of batches by 28% on the current output. It goes to show that any inefficiency, no matter how small, reduces potential capacity and a plant’s ability to deliver ROI.
The challenge of delivering a vaccine, when global demand outstrips supply and capacity is finite, is immense, especially if a version of it has to be produced every year. We should applaud the efforts global pharma companies are making to fulfil contracts, despite the hurdles. Shortages of glass vials and some raw materials have been cited as a cause for concern – but whatever supply chain pressures they face, their expertise and strategic use of technology can help to overcome them and drive up productivity.