From oral solid doses (OSD) and sterile injectables (SI) to complex biologics, Pfizer CentreOne provides premium manufacturing solutions across diverse modalities built on a decades-long legacy of bringing high-quality products to commercialization.

In this conversation with Contract Pharma, Jim Donovan, Vice President of Pfizer CentreOne, highlights the organization’s OSD network, which uses a structure that balances broad thought leadership with specific technical differentiation across sites. He emphasizes how Pfizer CentreOne helps customers navigate complexity in OSD manufacturing and speaks to broader industry themes such as selecting the right manufacturing approach and the importance of aligning network capabilities with long-term commercial goals.

Contract Pharma: What are the key market or scientific forces shaping complexity in today’s OSD development and manufacturing landscape?

Jim Donovan: The complexity in oral solid dose manufacturing today is being driven by both science and supply expectations. On the science side, we’re seeing more high potency compounds, modified release profiles, and molecules that require tighter control over processing and containment. At the same time, customers are looking to minimize capital investment while still achieving reliable, scalable commercial supply.

From a market perspective, there’s also much less tolerance for disruption. Products are expected to move efficiently from development into commercial manufacturing, and once they’re on the market, continuity of supply is critical. That combination of technical challenge and commercial pressure is why customers are increasingly looking for manufacturing partners with both depth of capability and network level resilience.

CP: Could you give an overview of Pfizer CentreOne’s oral solid dose (OSD) network and how it is structured across the sites in Ireland, Germany, and Italy?

Donovan: Pfizer CentreOne’s oral solid dose network is built around three strategically positioned manufacturing sites: Newbridge in Ireland, Freiburg in Germany, and Ascoli in Italy. Each site operates on a common foundation of Pfizer quality systems, GMP standards, and manufacturing discipline, but each also brings distinct technical strengths.

Rather than positioning these as interchangeable facilities, we operate them as a connected network. That allows us to align the right product with the right site, while giving customers confidence that their programs are supported by consistent systems and long-term operational stability.

CP: All three OSD sites—Newbridge, Freiberg, and Ascoli—share a consistent foundation of core capabilities. Could you expand on what those shared capabilities are and why this aligned platform is so critical for customers operating at commercial scale, particularly when it comes to reliability, quality, and long term supply continuity?

Donovan: Alignment across the network starts with shared quality systems, validated processes, and consistent manufacturing approaches. All three sites support core oral solid dose operations such as granulation, blending, compression, coating, and packaging under Pfizer’s global GMP framework. From highly potent, cytotoxic and controlled drugs – across capsules and tablets.

For customers at commercial scale, this consistency helps reduce risk. It simplifies tech transfer, supports regulatory confidence, and allows programs to evolve without having to relearn how a site operates. Ultimately, it helps ensure reliable supply over the long term, which is what matters most once a product reaches patients.

CP: Each site also brings unique technical strengths. Could you highlight the specialized capabilities at Newbridge, Freiberg, and Ascoli, and the types of programs each is best suited to support?

Donovan: This is where the strength of our network really comes through.

Newbridge is focused on complex, high value oral solid dose products. The site offers a rare combination of solvent coating and laser drilling for osmotic drug delivery, along with strong expertise in modified release technologies. It also supports high potency handling up to OEB 4–5, as well as Hot Melt Extrusion and Melt Spray Congeal. With pilot scale capabilities on site, Newbridge is particularly well suited for programs that need to move efficiently from development into scalable commercial manufacturing.

Freiburg is one of Pfizer’s largest oral solid dose sites and offers a true one stop solution across tablets, capsules, and multiple packaging formats. It has significant high containment commercial scale capability, much of which was recently added just a few years ago. Freiburg also brings broad global regulatory reach, including the ability to supply finished goods to Japan, and deep experience managing products across different lifecycle stages.

Ascoli is designed for flexibility and speed. It supports direct compression and dry granulation processes, with strong blister and bottle packaging capabilities featuring physically separated lines and online printing. The site is ready to begin tech transfer immediately, making it ideal for launches, transitions, and products with forecasted growth. Ascoli also offers hormone and selective oncology capabilities, supported by modern infrastructure such as electronic batch records and automated dispensing.

CP: How does Pfizer CentreOne maintain aligned quality systems and consistent manufacturing approaches across geographically dispersed sites?

Donovan: All three sites operate under Pfizer’s own global quality framework, with common standards for validation, documentation, and compliance. That foundation is reinforced through regular cross site engagement, audits, and leadership oversight.

Just as important, there’s a shared culture around quality and patient safety. Regardless of where a product is manufactured, the expectations are the same. That consistency gives customers confidence that they’re getting Pfizer level quality at every site.

CP: How do you ensure knowledge sharing, harmonization, and technical alignment across the network while still allowing each site to develop deep specialty expertise?

Donovan: We’re very intentional about balancing harmonization with specialization. Foundational processes and systems are standardized, but technical innovation and problem solving are encouraged locally. When a site develops a new approach or capability, we create mechanisms to share that knowledge across the network.

That way, expertise doesn’t stay siloed. It becomes a network asset. Customers benefit because they’re not just accessing the experience of one site—they’re tapping into the collective knowledge of the entire Pfizer CentreOne OSD organization whilst keeping each site as the center of excellence in their area expertise.

CP: When a customer comes to you with a new OSD program, what strategic factors guide the decision of which site is the best fit—not only from a technical perspective, but considering molecule characteristics, process complexity, commercial goals, and long term lifecycle needs?

Donovan: We take a holistic view that goes well beyond the immediate technical requirements. Molecule characteristics such as potency, formulation complexity, and process needs are important, but we also look closely at commercial objectives, geographic reach, packaging strategy, and how the product is expected to evolve over its lifecycle.

For example, a high potency or modified release product may align best with Newbridge, where we have deep expertise in complex oral solid dose manufacturing. A product intended for broad global distribution, including supply into highly regulated markets like Japan, may be better suited to Freiburg, given its scale, packaging flexibility, and regulatory readiness. For launch programs that require speed, flexibility, and the ability to manage forecast volatility, Ascoli’s rapid onboarding and customer centric operating model can be a strong fit.

Having a connected oral solid dose network allows us to match each program with the site—and long-term pathway—that gives it the greatest chance of success from launch through maturity and especially growth.

CP: In what ways does having a connected OSD network support long term commercial planning and lifecycle management for customers, particularly those looking for reliability, scalability, and continuity from launch through maturity?

Donovan: A connected network allows customers to plan with confidence. As demand changes or products mature, we can support scale up, optimization, or transition without disrupting supply. Customers aren’t locked into a single site solution—they’re supported by a system designed for continuity.

That long term perspective is especially valuable for products with extended commercial lifecycles, where reliability and consistency are critical year after year.

CP: Where do you see the greatest areas of innovation emerging within OSD manufacturing, and how is Pfizer CentreOne preparing for those future needs?

Donovan: Innovation in oral solid dose (OSD) manufacturing is increasingly focused on enabling complex molecules, improving operational agility, and maintaining uncompromising quality and safety as potency and complexity rise.

A clear example of how we are preparing for these future needs is our continued investment in advanced containment and high‑potency manufacturing. At our Freiburg site, the state‑of‑the‑art high‑containment (HighCon) facility was added and opened in 2022, expanding our ability to safely and efficiently manufacture highly potent OSD products within a modern, automated environment designed to support complex molecules at scale.

Beyond physical infrastructure, the next wave of innovation in OSD is being shaped by the evolution from Pharma 4.0 to Pharma 5.0. As outlined in our Pharma 5.0 OSD materials, Pharma 5.0 brings together human expertise with advanced digital technologies, including AI, machine learning, advanced analytics, and digital simulations, to help simplify complexity, strengthen reliability, and enable more agile, intelligent manufacturing decision‑making. Across Pfizer CentreOne, we are actively exploring how these tools can be applied—where available and appropriate—to enhance process understanding, support real‑time monitoring, and help maintain consistent product quality across increasingly complex OSD programs.

We continue to invest in capabilities that address today’s OSD challenges while preparing for what’s next—combining advanced containment, smart automation, digital innovation, and deep scientific expertise. All of this is guided by a clear priority: delivering reliable, high‑quality OSD supply that helps our partners bring important therapies to patients, safely and efficiently, now and in the future.

CP: As CDMO partnerships become more strategic, what qualities do you believe customers will value most in next generation OSD manufacturing networks?

Donovan: Customers are looking for a CMO who combine technical capability with reliability, transparency, and a long term mindset. They want to know that their manufacturing organization understands their product, their business, and their patients.

At Pfizer CentreOne, our oral solid dose network is built to deliver exactly that—Pfizer level quality, site specific expertise, and a collaborative approach that supports customers from launch through maturity.