In order to mass produce a treatment for the current global pandemic, pharmaceutical manufacturers need to stretch their capacity to its fullest. Could production planning and scheduling be the key that unlocks improved throughput and maximised yield?
The numbers reflecting the rapid global spread of Coronavirus (Covid-19) are devastating. Almost 1.9 million cases have been confirmed in 176 countries with more than 119,000 deaths, according to the latest WHO statistics (as of 15 April, 2020).
In the face of such a global crisis, pharmaceutical manufacturers are experiencing mounting pressure to produce treatments and develop a potential vaccine.
At this time, reports suggest we are still many months from having an approved vaccine, let alone manufactured and administered in high volumes. The more immediate focus, therefore, is on developing a specific treatment.
Presently, the front-runner for treatment is Remdesivir, developed by the US biotech company Gilead Sciences to treat the Ebola virus epidemic of 2013-16.
“Remdesivir has an established safety profile and multiple clinical trials around the world are currently underway to determine its effectiveness against Covid-19,” explains Rod Schregardus, a day-to-day scheduling, capacity planning and ‘what-if’ analysis expert, specialising in the biopharma and MedTech industries.
“Due to its advanced position, Remdesivir is likely to hit the market faster than a vaccine. The challenge for both treatments and vaccines is how to move them out of the R&D lab and into mass production as quickly and smoothly as possible.”
A pharmaceutical company such as Gilead Sciences has manufacturing sites, but they will have existing manufacturing commitments, often sponsored at the state level.
If the plant is producing vaccines for Tamiflu, for example, that’s a multi-decade contract to maintain a minimum national stock level. Production can’t easily be interrupted or mothballed to manufacture something else.
“The process of producing a vaccine to Covid-19 is going to be very complex, involving anywhere up to 1,000 separate operations,” Rod notes. “There are only a limited number of companies that can handle that level of complexity, every one of which is likely to already be operating at full capacity.”
The key question, therefore, is how does a manufacturer improve throughput and maximise yield in and around existing commitments?
That’s where production planning and scheduling software comes in, such as Access Orchestrate.
“The Access Group is experiencing a huge demand from biopharma companies,” says Rod. “Access Orchestrate is ideally suited to the needs of the pharmaceutical sector, such as enabling time-critical scheduling – vital when dealing with perishable drugs and raw ingredients with short shelf-lives, and regulatory compliance.”
“Many companies still operate from spreadsheets and even whiteboards or Post-It Notes in extreme cases,” Rod continues. “Many of the spreadsheets I see are vast and complex, but they don’t offer anywhere near the granularity or real-time accuracy agile manufacturers require.
“They also tend to be error-prone, rely on individuals, and are ill-equipped to conduct robust scenario analysis. Updating these sheets when the landscape suddenly changes, such as it has recently, can take days, even weeks, and that’s simply not good enough.”
Manufacturers are realising their need for a scalable production planning and scheduling solution that enables them to accurately map out their current processes in and around their constraints of equipment, labour and materials. That map can then be overlaid with potential new jobs or workflows.
This capability is what makes planning and scheduling software so essential, believes Rod; enabling a business to prove to themselves and a prospective client that additional work can be successfully undertaken alongside existing commitments and limitations.
These models can also be used to ‘re-play’ previous production cycles but with an additional piece of equipment or production line, greatly helping to validate potential future investment decisions.
“Equally important is the ability for team leaders to easily view, understand and plan exactly how many workers are needed for a particular shift, which Orchestrate allows you to do.” Rod says.
“The same goes for equipment maintenance. Having a remotely-accessible, single version of the truth makes it much easier to schedule maintenance-related downtime around production demands.”
Demonstrating the power of ‘what-if’
Two businesses already reaping the benefits of having a trusted production planning and scheduling tool are Baseline Controls, located in Raleigh, North Carolina, and a leading pharmaceutical company.
Baseline Controls is a world-renowned planning and engineering consultancy that works with international clients operating in different industries, each of which relies on mission-critical scheduling and planning to deliver complex, high-value projects.
Its planning expertise was commissioned to carry out a design capacity analysis for a $1bn facility tasked with producing enough vaccines for half the US population in the event of, rather presciently, a possible flu pandemic.
As a public-private initiative between the US government and a leading pharmaceutical company, a detailed review had to be conducted to determine whether the facility was capable of producing the required 150 million doses in just six months.
“Since the facility wasn’t yet running at full capacity, we needed a model to evaluate if the facility could deliver on its full design objectives,” explains Adam Barlow, principal and founder of Baseline Controls.
The business needed a planning and scheduling solution that was optimised for the pharmaceutical industry and allowed users to carry out ‘what-if’ analysis, among other functions, and make the best use of available resources to save time, reduce waste and improve operational efficiency. The business chose Access Orchestrate.
Using Access Orchestrate, Baseline Controls’ team were able to conduct a detailed analysis of capacity long before full production had begun. Once the model was built, and the level of demand identified, the consultants could show how long each batch run would take – and crucially, highlight any areas where equipment was being over or under-utilised. All in less than two weeks.
The findings not only provided the reassurance the client needed that the manufacturing site could, with some strategic process improvement projects, produce the number of vaccines required, they also revealed how the facility could speed up the entire demand delivery by three weeks.