Disrupting the Bioprocessing Footprint
With an unprecedented patent cliff looming and complex modalities on the rise, executive teams must decouple capital investment risk from clinical uncertainty by embracing flexible, intensified manufacturing platforms.
The biopharmaceutical industry is moving away from the traditional blockbuster drug model, where facilities manufactured vast quantities of a single product, toward more personalized, highly targeted therapies and complex bioconjugates. As a result of this shift, strategies around capacity planning, facility design, and industrialization are changing. To find out more about how varying pipelines are altering manufacturing baselines, The Pharma Navigator spoke with Miriam Monge, Head of Customer and Industry Advocacy Strategy at Sartorius.
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Redefining the Pipeline
TPN: Biopharma is transitioning away from uniform blockbusters toward more personalized, highly targeted therapies, complex bioconjugates, and smaller patient populations. From an infrastructure perspective, how has this altered the baseline math when planning multi-year capacity? Is the industry moving away from dedicated lines?
Monge: Clearly what we've seen is that the blockbuster model that we saw for so many years — where you had companies manufacturing tons of proteins, so monoclonal antibodies — is really dying and we're seeing a strong shift away from that model. If you look at the molecule pipeline today, only 20% or less of the molecules may require more than a ton per year, and actually 50% require less than 100 kg per year. So, of course, that means that you're moving to the requirement for much smaller-scale facilities.
Linked with that, of course, we've seen the need for increased titers and, also, some of the complex molecules — the bispecifics and trispecifics — don't work well in a typical fed-batch mode. To be able increase the titers, it is necessary to have intensified manufacturing technologies. Again, this means overall, facilities are required that are able to manufacture multi-modalities at considerably smaller quantities.
In addition to that, there is a looming patent cliff like we've never seen before. Over the next 10 years, there are 50 blockbuster drugs that are coming off patent. To give you an example, looking at AbbVie's Humira, that represents 600 kg per year, and now, after coming off patent, the company is competing against 30 biosimilar manufacturers for those 600 kg per year.
Effectively, as a result of these factors, there is a strong shift towards smaller scale, highly flexible facilities in terms of the capacity landscape. However, we will still see about 20% with those large-scale facilities for the remaining blockbuster drugs.
Single-Use Modularity
TPN: Building out modern, state-of-the-art facilities certainly carries immense capital expenditure. When designing for modularity and flexibility, what are the primary operational challenges in ensuring that a facility can pivot between different complex modalities without facing extensive downtime or cleaning validation bottlenecks?
Monge: Well, that is indeed the reason why we've seen the industry transition so much towards single-use technologies (SUTs), because SUTs inherently bring that flexibility. You can rapidly reconfigure SUT platforms in a way you cannot with stainless steel facilities.
One of the big issues with stainless steel facilities is the long build time, often taking three to five years. Additionally, in some instances, there's only about 10% of the molecules in the pipeline that actually make it to market. So, sometimes the molecules for which those stainless-steel facilities have been designed don’t make it to market. Then those facilities end up being used to manufacture something else, which wasn't necessarily the perfect size or scale, and the result is highly inefficient facilities.
Whereas with SUTs, you can delay investment decisions until considerably later because the build time for a SUT facility is much shorter because you can effectively decouple the building of the facility. You could also use a modular facility, which is even quicker to build, and then you have a design of a single use process platform in parallel. So typically, you should be able to get a SUT platform up and running in 18 months, or in some cases, even less.
For example, during COVID, we had to rapidly configure manufacturing lines for the COVID vaccines. We had to do that in a matter of months. If we had to wait for stainless steel to accommodate the vaccine manufacturing, it would have taken considerably longer. So, that's the real value of SUT platforms.
The Retrofit Dilemma
TPN: When a facility needs to adapt to next-generation manufacturing needs, retrofitting an existing footprint is often seen as a faster, more cost-effective option than building greenfield. However, what are the structural or facility-level limitations where a retrofit can become more restrictive than starting from scratch?
Monge: Obviously, the disadvantage of retrofitting is that you can't benefit as much from the latest generation technologies. You may just be able to implement one or two process steps, so you end up with a sort of hybrid facility.
Of course, when you're implementing new, next-generation technologies, such as process intensification, from scratch you can look at how to downsize your water systems and you can considerably reduce the footprint of your process in the cleanroom, which means that you can downsize your HVAC systems — the biggest energy consumer in your facility.
So, there are multiple benefits of moving to a completely new manufacturing facility, it all depends on your timelines. You can potentially implement a new single-use based facility in less than 18 months, even faster if using existing modules — these modular facility concepts like those from GCON, for example. It's really a trade-off depending on the time frame. If you've only got six months then you're just going to implement a few process step improvements, but will run the risk of having a less efficient facility because you'll probably end up with two large size water systems, HVAC systems, and so on.
Resolving Business Imperatives
TPN: How should executive teams balance the immediate pressure of clinical timelines with long-term commercial compliance when deciding whether to modify an established site versus breaking ground on a brand-new facility?
Monge: This precise topic was tackled by Dr. Rhonda Duffy, Chief Operations Officer at Biocon during the Sartorius PI forum in India in June 2026 (1). Dr. Duffy was talking a lot about balancing the science, industrialization, and business imperatives. Of course, at the end of the day, the ultimate issue is speed.
Dr. Duffy is focused on biosimilars and for a biosimilar, those who get to market first get the lion's share of the cake, right? And so that speed is everything. So, from her perspective, ideally, you need to design these next-generation technologies into the process development so that you can then rapidly implement and go to market with a biosimilar very fast and in the most cost-effective way.
Dr. Duffy explained, of course, that if you start retrofitting or even trying to go to a completely new manufacturing technology, inevitably, you're going to run into hurdles because, if that product's already in filing, you're going to then need to redo stability studies. In such an instance, you're likely to lose about 18 months and then you may not be first to market or even second or third, and then you're only going to get the breadcrumbs, so to speak, at the end of the race.
That’s the difficulty and Dr. Duffy talked a lot about the commercial challenges and why scientists and manufacturers need to understand the balance between the science and the commercial imperatives. That business case is extremely important.
Avoiding Tech Transfer Risks
TPN: A common misstep in the industry is equating sheer tank capacity or square footage with actual technological capability. What are the risks a development program faces when an organization expands its physical footprint without matching investment in analytical depth and process development infrastructure?
Monge: There are considerable risks. I mean, if you think about tech transferring into a new manufacturing facility, it often requires multiple process changes, which introduce risk to process performance and product quality. Additionally, there can be many differences between facilities, like differences in seed train design, bioreactor scale up, or chromatography set up. So, really, robust analytical capabilities are critical to be able to monitor the impact of the potential changes and also process development capabilities are important to be able to build and use downscaled models, characterize a large-scale process design.
What we're seeing more and more is the increasing use of high-throughput systems, such as the Ambr 250, as they provide scalable downscale models and enhanced process analytical technologies capabilities. So, really you need to be able to reduce the development and tech transfer risk.
Keeping the End in Mind
TPN: Early-stage processes frequently stall as they scale because they were optimized for immediate speed rather than long-term industrial manufacturing realities. What should companies avoid doing when transitioning a complex biologic or bioconjugate from bench-scale discovery into a CGMP environment?
Monge: Clearly the scientists need to really start with the end in mind and think about the need to develop and design scalable platforms from the outset. The worst that can happen is that technology is designed to research scale and only customized specifically for that, then they're not able to be scaled up and implemented into CDMOs, for example.
The examples really start at the choice of expression systems. So, you need to think, for example, about the cell line history: Has it been well described? Has it already been used in approved products? Can it be cultured in suspension in large scale tank bioreactors? Is it suitable for process intensification? These are all the sorts of things that the scientists need to think about in the design of their process to ensure it's suitable to scale.
Also, media choice is critical: Is it animal component free? Does it not contain the highly expensive or non-GMP available components? Of course, all the manufacturing technologies — the bioreactor, the cell retention technologies, the downstream processing technologies — they all need to be fully scalable and the scientists need to think about the full industrialization.
Reference
Sartorius. Sartorius PI Forum India 2026. Sartorius.com, accessed June 22, 2026.
About the Speaker
Miriam Monge is Head of Customer and Industry Advocacy Strategy for Sartorius Bioprocess Solutions. With over 25 years’ experience with Sartorius, Miriam has witnessed and participated in the evolution of single-use technologies. In her current role, Miriam is responsible for drafting a unified market presence that resonates with stakeholders and solidifies the company’s market position.
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