“Don’t pick a CMO that just agrees with you.”
Isabel Feuerstein is Head of Business Development for EU and Asia CMO at Novartis, where she shapes the company’s contract manufacturing strategy across key global markets. Mark Schiefermeier leads the manufacturing unit at DS Schaftenau, one of Novartis’ critical drug substance manufacturing facilities in Austria, overseeing technical execution and quality systems that underpin Novartis’ external manufacturing commitments.
In this episode of the PharmaSource podcast, Isabel and Mark explain why technical credibility, real transparency, and a willingness to challenge clients are the foundations of a high-performing CDMO relationship — and how Novartis is positioning its CMO business for the future of biologics.
Technical Fluency as a Competitive Advantage
Both Isabel and Mark share roots in protein analysis and molecular characterization — a background that shapes how they communicate with clients and with each other today.
“Back when we analyzed and characterized proteins together, we really looked in depth,” says Isabel. “I understand the complexity, and I know what it means — so I can acknowledge it with our clients before we step into a technical discussion.”
Mark explains the value of technically competent BD colleagues. “Isabel very quickly catches up — and by that, you can avoid endless back-and-forth discussions,” he says. “She, and our other BD colleagues, really understand where a problem is, how you can solve it, and how to tackle it.”
For biotech companies evaluating CDMOs, this point is worth noting. The quality of a BD team’s technical understanding has an impact on how efficiently early-stage conversations translate into viable manufacturing programmes.
Digital Integration: Pragmatic, Not Performative
Novartis is investing in three interconnected digital pillars: vertical integration of data systems, AI, and robotics and automation. But the framing is practical.
“We don’t want to digitalize or use AI just for the sake of digitalization,” says Isabel. “We want to make sure that it gives us value — for us and for the client.”
Mark elaborates: “It is about being cost-efficient, but it also goes hand-in-hand with quality — reducing human error and delivering the highest quality.”
The emphasis on AI and robotics as quality tools, not just efficiency levers, reflects that technology investments must be justified by measurable outcomes, not marketing narratives.
Transparency as a Structural Expectation
Sponsors are no longer satisfied with batch updates and periodic reports. Real-time data access and operational transparency have become table stakes.
“Clients get access to our data — this is a must,” says Mark. “They have to understand what is going on, and they can view and watch the processes.”
Isabel expands on what transparency means in practice beyond data alone. “It’s transparency on available capacity, on how we share our way of working. It’s not just supplying products — it’s more about a partnership these days.”
She also raises an important nuance: data access alone isn’t enough. “You also have to be sure that they can handle the information and interpret it in the right way. And this we also support.”
This framing positions Novartis as an interpretive partner. One that helps clients contextualize what they’re seeing and make better decisions as a result.
Balancing Internal Standards With Client Needs
One common concern biotech companies raise about partnering with CDMOs with a pharma business is: will our programme be treated as a priority, or will it always sit behind internal pipeline needs?
Isabel addresses this. The objections she encounters aren’t really about programme prioritization, but about the cultural and operational challenges of engaging in third-party business at all: differing standards, ways of working, and what it means for a company like Novartis to open its manufacturing network to external partners.
“These objections exist on both sides — internally within Novartis, and externally from partners or clients,” she says. “We take great pride in our standards and the discipline that underpins them, and we never compromise on the fundamentals. At the same time, working with external clients requires us to be truly open to their needs and ways of working — because ultimately, it’s their programme and their priorities that matter.”
With more than 20 active clients, Isabel is clear that every programme receives the same level of dedication as an internal one. “Not meeting our obligations would seriously affect our reputation — not just as a CMO, but as an innovator responsible for manufacturing life-saving medicines.”
Mark reinforces this: “The Novartis standards are not debatable. But the way companies follow different strategies to achieve the same goal — sometimes you can learn from each other and grow together.”
Cost Effectiveness and Innovation: Not a Trade-Off
Cost pressure is a reality for biologics manufacturers in 2026. Rather than treating innovation and cost efficiency as competing priorities, Novartis frames them as interdependent.
“We challenge every innovation project early against cost efficiency,” says Mark. “Not to run into techniques and innovations that don’t deliver on the cost side — or the quality side.”
For Isabel, recent capability investments have translated directly into commercial conversations. “We can now go in with very competitive prices, which is very relevant for a lot of companies. Investing in technologies like N-1 perfusion and next-generation biologics also gives a signal to our customers that we constantly invest — not only for our own programmes, but for theirs too.”
Sustainability: From Commitment to Measurable Action
Environmental performance is now a selection criterion for many sponsors evaluating CDMOs, particularly under pressure to reduce Scope 3 emissions.
Novartis has made concrete moves at the site level. “We recently switched from gas to electrical energy and are moving toward being completely CO2 neutral,” says Mark. “We have projects running that tackle reducing energy consumption and water consumption — with every new technique, we evaluate in this direction.”
Isabel points to the collaborative dimension. “It’s a win-win situation. Our clients can learn from what Novartis does, but we can also learn from them. A collaborative approach to sustainability in ESG is really going to help the industry move forward.”
Novartis publishes an annual sustainability report, with individual site-level objectives tracked across the network — giving potential partners a concrete basis for due diligence.
Schaftenau: A Site Built for the Full Biologics Lifecycle
DS Schaftenau has evolved significantly over the past decade. What began as a facility focused on clinical-stage supply for the internal Novartis network has expanded into a full-lifecycle, end-to-end biologics manufacturing site.
“We have a wide variety — from very early stage clinical development to high-throughput commercial manufacturing,” says Mark. “We have development onsite, analytics in every direction, and a big footprint in drug product manufacturing. We understand the process from beginning to end.”
Current technology investments are focused on maximizing process efficiency — increasing throughput, reducing runtime, and moving analytics in-line to reduce production time. “We focus very much on having our process online and under control,” Mark explains. “We support different operating modes: fed-batch, continuous technologies, N-1 perfusion. This depends on whether it’s an old process or a new process — and we have the capability for all of them.”
A Global Network for a De-Risked Supply Chain
Geopolitical complexity has made single-source supply strategies increasingly untenable. Novartis’ recent announcement of US investment adds a critical third node to a network that already spans Europe and Asia.
“These days, it’s very important to have different supply points — not only rely on one,” says Isabel. “We can offer a global network for biologics, aseptic filling, and small molecules. That’s where I really see the strengths of Novartis. And it gives our customers the commitment that we are there for them.”
What to Actually Look For in a CDMO Partner
“Prioritize culture, quality, transparency, and a proven track record in scaling up a process,” says Isabel. “And I would not choose a CMO that will just agree. I would pick a CMO that challenges you — with facts.”
Mark adds: “Ask your selected CDMO about their troubles. If everything is shiny and they can’t speak about the challenges they’ve had — you have to get suspicious.”
PharmaSource is pleased to host Novartis at CDMO Live Europe 2026 as a platinum sponsor.
