Shifting biopharma’s manufacturing into the fast lane
As the past year has shown, the ability to be both malleable and swift are powerful assets in the face of virulent diseases.
In May 2020, as the US’s Covid-19 death toll fast approached 100,000,1 a sense of urgency swept through Washington DC’s policymakers as it became clear that action was needed — sooner rather than later.
Enter Operation Warp Speed. The programme, launched in tandem with the private sector in order to overcome the pandemic, was named as such in recognition of the fact that anything less than a rapid response was not an option. Among its many objectives, some of Operation Warp Speed’s most critical goals were related to manufacturing and distributing vaccines as quickly and safely as possible.2
As the past year has shown, the ability to be both malleable and swift is a powerful asset in the face of virulent diseases, but it also helps to ensure sufficient preparedness in case of another public health shock.
The industry has shown that it can move with speed on manufacturing, but new research suggests that that is not always the case.
Cytiva’s Global Biopharma Resilience Index assesses the strength of five areas (‘pillars’) of the biopharma industry based on a survey of more than 1,100 pharma and biopharma executives and healthcare policymakers from 20 countries.
Domestic capacity at risk
There is a clear bright spot in the index: manufacturing agility. As we would expect, many high-income countries did well here, with the likes of the US, UK and Switzerland all scoring more than seven out of 10 on this index pillar (see chart 1), but many lower to middle-income countries, such as China, India and Russia, proved that they could keep pace too.
But there are some areas that need work. Domestic pharma firms have some doubts about their capacity to meet their own nation’s needs for a number of drugs, scoring less than five out of 10 on this index indicator. Take insulin and vaccines, for example. Respondents say they would only be able to meet 75% of local needs in the event of a surge in demand. That drops to just 58% for other biopharmaceuticals. This highlights the lack of capacity and speed with which countries can currently respond to demand fluctuations.
Chart 1: Manufacturing agility index scores by gross national income per capita
Pharma and biopharma executives recognise this weakness. Fewer than 3 in 10 describe the manufacturing processes of their organization as something that offers a competitive advantage, and increases in manufacturing agility emerge as the number one priority for firms.
But to achieve this goal there are impediments in domestic markets that need to be addressed. Among the top three outlined by executives are a lack of skills within companies to drive the manufacturing speed desired, geopolitical developments that could impact the rollout of a drug and crucially, a lack of agility among suppliers.
Picking up the pace
Perhaps the most important suppliers for pharma and biopharma firms are the contract manufacturing organizations or contract development and manufacturing organizations (CMOs or CDMOs). These are external firms to which pharma and biopharma businesses can outsource critical stages of drug development and manufacturing.
One solution to concerns about speed has been the rise of firms that can work with CMOs to offer rapidly scalable manufacturing facilities that reduce the need for a large upfront investment, enabling a much quicker process — particularly in smaller countries where that might not be feasible.
However just a quarter of executives rated CMOs as being “very good” on adaptability and cost-effectiveness, despite a generally positive sentiment towards their performance (in the index, CMO performance scored 7.39 out of 10). This shows that if CMOs and pharma firms can work in tandem to adapt facilities for the manufacture of one drug or vaccine to another, it would help to drive down costs and shorten a process that can otherwise create significant delays. It also suggests that manufacturers will need to develop their own scalable and flexible facilities to meet demand — even when they are not expecting it.
“We are looking at transforming the entire manufacturing process. If you look at the chemicals and petroleum industry, all manufacturing is continuous, but the pharma industry is batch processed,” says Dr Chris Chen, chief executive of WuXi Biologics, a Chinese CDMO. “So we believe the next stage is to go from batch to continuous. If you look at the petroleum industry, if they went to batch processing they would go bankrupt because they have to rely on very high efficiency.”
Executives are keen for more innovative technologies too. Less than one in five are in strong agreement with the idea that frontier technologies such as artificial intelligence are being widely adopted in a widespread way to support the automation of certain processes that could speed things up.
Chart 2: Manufacturing agility could make gains with development of scalable facilities and more investment in technology
Overall, the index findings lay a clear roadmap for pharma and biopharma firms looking to bring agility that want to make their manufacturing operations more agile: think strategically about the role of rapidly scalable operations that reduce upfront costs, and be bolder with adopting technology.
Manufacturing agility on the ground
Of course, many firms have taken a lead on these changes already, and that includes pharma giants Samsung Biologics and Amgen. We sit down with each of them to find out how they have achieved manufacturing agility, and what lessons the wider industry can take away.
In conversation with
Chief executive of Samsung Biologics
How important is technology in accelerating stages of drug development and manufacturing?
Innovative technologies are becoming increasingly important. We are committed to adopting cutting-edge technologies that can help expedite the drug development and manufacturing process.
We are continuously looking for ways to implement new technologies to enhance, improve, and optimise our processes. Ultimately, we aim to deliver optimised efficiency. The industry is going through a digital transformation and it’s important that companies are ready to embrace new practices.
What are you doing to improve industry readiness and agility?
Samsung Biologics has recently begun construction for its new facility, Plant 4. Also known as the Super Plant, it will be the most ambitious project to date.
It is designed to be fully flexible and with our experienced engineers, it can be optimised to accommodate various client requests and the changing requirements of the industry, ensuring the shortest turnaround time.
Which technologies do you plan to invest in?
We have begun a Quality Digital Transformation Initiative, which will be completed by the time Plant 4 is operational. The digitalised quality initiative will give our clients live, 24/7 access to computerised systems related to their campaigns, and regulatory authorities will have full remote access to documentation, including quality records.
A closer look
How Amgen stays agile
Arleen Paulino has reason to be proud of Amgen. “We have served every patient, every time, because we have not had a shortage,” she says.
As senior vice president of global manufacturing at the Californian biotech firm, Paulino has been central to that achievement, with what she describes as a “very programmatic approach to resilience” in manufacturing. So what is the secret?
“As part of developing our processes and our manufacturing operations, we’re constantly looking for ways to be more agile with technology,” she says. “Can you implement technologies that drive your productivity and your processes so that you can miniaturize, if you will, the operations?”
The benefits to being proactive on technology primarily relate to efficiency. Firstly, Paulino explains, it helps to find ways of reducing footprint in a way that “translates into improved costs and speed”. Secondly, it helps Amgen to find ways to scale up facilities faster.
The company also takes a proactive approach during manufacturing towards its inventory, maintaining both ample operational safety stock, and strategic safety stock of its drugs, and monitoring levels very closely.
“For example, if it takes three months to recover from a specific incident, we may choose to say, "Well, let's maintain six months of inventory to give ourselves room," says Paulino.
Agility then, is much about responding with speed as it is about ensuring emergency reserves are available when they are needed.