Where are the biggest points of friction between drug development and commercial manufacturing today, and how can the industry remove them? FUJIFILM Biotechnologies, Systech and Pace Life Sciences discuss.
Christiane Bardroff, chief business officer, FUJIFILM Biotechnologies
1. Where do you see the biggest points of friction as a drug moves from development into commercial
FUJIFILM Biotechnologies
manufacturing today?
The biggest point of friction comes when manufacturing enters the conversation too late. A process may work in development, but commercial supply has different requirements across equipment types and scale. A cell line may perform well in development, then require significant redesign when demand changes, the process moves from single-use to stainless steel or from small-scale to large-scale. These variables can affect comparability, process characterisation, and validation.
The companies that succeed are the ones that build manufacturing into development from day one and mitigate risk by aligning innovative technologies and regulatory expectations into a broad and unified manufacturing- and supply-strategy.
2. What needs to change in manufacturing strategy to reduce those barriers?
Reducing barriers in manufacturing strategy can be achieved through involving a CDMO or outsourcing partner earlier on, at the concepting stage.
Today’s CDMOs offer far more than capacity - they bring innovative technical depth, execution reliability, supply assurance, and the agility to respond as demand, technologies, and regional requirements evolve.
To fully unlock that value, upstream and downstream strategies must be developed in concert, built on standardised equipment platforms, aligned process ranges, and a common control strategy that spans end-to-end from pre-clinical through commercial. This integrated approach streamlines tech transfer and accelerates scale-up. It’s the practical premise behind kojoX, FUJIFILM Biotechnologies’ operating system, which aligns common equipment, standardised processes, and harmonised digital systems to make programs more easily transferable across scales, facilities, and regions.
3. Looking ahead, what will be most important in making the transition from development to commercial supply faster, more scalable and more resilient?
We also need to reframe our perspective when it comes to manufacturing strategies and focus on flexibility. Scaling is not always one-dimensional: a connected and integrated manufacturing ecosystem supports scale-up, scale-down, and scale-out -- addressing a variety of lifecycle and demand profiles.
- Single-use systems can support early and rapid clinical supply.
- Multi-lane facilities can run parallel trains. Continuous or intensified upstream and downstream processing can increase productivity without expanding the physical footprint.
- Large-scale stainless steel remains essential for sustained commercial volumes for products with high/frequent doses and large patient populations.
The fastest, most resilient path from development to global supply comes from an integrated ecosystem that unifies multi-scale assets, standardises operations, and employs adaptive technologies so that programs can move across scale and geography with speed, consistency, and confidence according to life cycle requirements to meet patient needs.
Steve Engdahl, VP, product management at Systech
1. Where do you see the biggest points of friction as a drug moves from development into commercial
Systech
manufacturing today?
For me, the biggest challenge is getting the systems, data, processes and partners involved in commercial manufacturing to work together. The operation becomes more complex as volumes increase and additional capacity comes online. If those elements are not aligned, small gaps can quickly affect efficiency or product availability.
The systems themselves are one pressure point. Software cannot be treated separately from the equipment running on the packaging line because the quality of the data depends on what happens there. That data then needs to remain consistent as it moves between systems. Manufacturers also need enough automation and visibility to understand what is happening across the operation without relying on manual investigation.
The same principle applies to partners. Everyone involved needs a shared view of the operation and a straightforward way to collaborate. That becomes especially important when something goes wrong, because a resilient network must support a coordinated response rather than simply function under normal conditions.
2. What needs to change in manufacturing strategy to reduce those barriers?
I think manufacturers need to plan for connectivity from the outset, rather than joining systems together as the commercial network grows. That shift affects three areas:
- Systems: Packaging equipment and software need to operate as one environment, so information generated on the line remains useful at site and enterprise level.
- The wider network: Internal teams and external partners need a consistent view of what is happening, along with clear ownership when an issue occurs.
- Digital tools: Companies need to understand the quality of their data and establish appropriate oversight before applying AI within a regulated process.
These areas are closely related. You cannot gain meaningful network visibility if the underlying systems produce inconsistent information. Equally, visibility does not solve the problem if nobody knows who should act. Getting those foundations right gives manufacturers a more dependable operation today and a practical basis for introducing further automation over time.
3. Looking ahead, what will be most important in making the transition from development to commercial supply faster, more scalable and more resilient?
The most important step will be to consider commercial supply requirements earlier. One practical way to do that is to engage suppliers before key development decisions have been fixed. The right vendor should act as an advisor: someone who has supported commercialisation before, understands the decisions that need to be made today and can, as I like to say, help you “see around the corner.” That experience can help manufacturers build an operating foundation that supports their immediate needs without limiting where they want to go as volumes increase.
From there, the focus should be on maintaining one reliable view of the operation as new sites or partners join the network. Teams need to see issues early and understand their possible effect on supply. Clear responsibilities across a shared view of data allow the right people to respond without first having to reconcile conflicting information. When manufacturers combine earlier planning with dependable network visibility, they can add capacity or enter new markets without redesigning the operating model each time.
Frank Tagliaferri, chief scientific officer at Pace Life Sciences
1. Where do you see the biggest points of friction as a drug moves from development into commercial
Pace Life Sciences
manufacturing today?
Many of the biggest points of friction originate much earlier than commercial manufacturing. Sponsors can focus heavily on reaching the clinic without fully considering the analytical methods, long-term stability evidence, formulation choices and container-closure requirements that commercial supply will eventually demand.
A product may have sufficient short-term stability data for an early clinical study, for example, while trends such as increasing particle size already indicate future problems. Organisational silos can compound the issue, with clinical, CMC and manufacturing teams making decisions without enough shared information.
When these risks are identified later, the product and process are harder and more expensive to change. The transition becomes much smoother when teams understand the molecule as a developable and manufacturable product from the outset, rather than treating commercial readiness as a future-stage requirement.
2. What needs to change in manufacturing strategy to reduce those barriers?
Manufacturing strategy needs to begin earlier and become more integrated with development and analytical planning. Sponsors should involve experienced partners while there is still scope to challenge the strategy, rather than asking them to execute decisions that have already been fixed.
That means selecting the appropriate solid form, establishing robust analytical methods, monitoring stability trends and assessing container-closure and administration-system compatibility before these become late-stage problems. Clinical, CMC, analytical and manufacturing teams must also communicate more closely so that immediate development decisions reflect eventual commercial requirements.
The objective is not to design the entire commercial process during Phase I. It is to make early decisions with a clear understanding of their downstream consequences. This creates stronger data, preserves future options and reduces the risk of costly investigation, redevelopment or regulatory delay.
3. Looking ahead, what will be most important in making the transition from development to commercial supply faster, more scalable and more resilient?
The most important change will be building commercial readiness into development from the beginning. Sponsors need analytical methods, stability programs and testing strategies that can evolve with the product rather than having to be replaced as requirements increase.
Speed will come from removing avoidable delays: involving the right expertise earlier, using material-sparing techniques, developing fit-for-purpose methods and identifying formulation, impurity or compatibility risks while they remain manageable. Scalability will depend on understanding how early choices affect later manufacturing and regulatory expectations.
Resilience also requires flexible partnerships and direct access to the scientists closest to the data, particularly when unexpected findings change the plan. As regulatory expectations become more aligned across the US, Europe and Asia, designing to robust global standards from the outset will help sponsors avoid fragmented regional solutions and create a more commercially viable supply strategy.