In this exclusive interview, Jim Donovan, VP and General Manager of Pfizer CentreOne, shares real-world insights on navigating the toughest challenges in ADC and biologics manufacturing: from high-containment conjugation and accelerated tech transfer to supply chain resilience and regulatory readiness.

As Track Sponsor for R&D Excellence - Biologics at CPHI Americas 2026, Pfizer CentreOne brings unparalleled expertise in complex modalities to one of the industry's most critical conversations. With a manufacturing legacy that includes the world's first commercially approved ADC product and a proven track record of scaling advanced biologics at commercial scale, Pfizer CentreOne is driving innovation where it matters most—delivering life-changing therapies to patients waiting.

1. How does Pfizer’s sponsorship of the R&D Excellence - Biologics track at CPHI Americas 2026 align with Pfizer’s strategy to advance complex biologics (ADC in PC1 case) manufacturing at commercial scale?

"At Pfizer, we’re investing attention and leadership time where the industry is moving toward complex modalities that demand specialised manufacturing. Sponsoring the Next Gen Biologics track gives us a platform to share what we’ve learned scaling ADCs in real-world conditions: accelerating tech transfer and building supply resilience.

From a Pfizer CentreOne perspective, ADCs are a clear example of where advanced capability and disciplined execution matter. Across Pearl River and North Creek, we support ADC drug substance manufacturing with single-use flow paths, high containment conjugation suites, and in-house QC for in-process, release, and stability testing — all focused on delivering consistent outcomes for programmes at critical stages."

2. What are some of the most critical challenges in biologics and ADC manufacturing today (such as scale-up, containment, quality, and supply reliability) and how has Pfizer addressed these through its manufacturing network and specialized sites?

"When you look at ADC manufacturing specifically, the challenges are very real and very interconnected. You’re dealing with the complexity of biologics and the pressure to scale reliably — often on very compressed timelines. Containment, consistency at scale, analytical depth, and supply reliability all tend to show up at the same time, and if one area isn’t right, it can slow everything down.At Pfizer CentreOne, we’ve approached this by being very intentional about how and where ADCs are manufactured. Our sites are designed around the realities of these molecules. For example, we use segregated, single-use conjugation suites that support safe handling of cytotoxic materials while also enabling faster changeover between programmes. That flexibility becomes increasingly important as products move from late-stage development into commercial supply.We’ve also invested heavily in quality and analytical capability alongside manufacturing, so teams can make informed decisions quickly and confidently. 

And just as important, we focus on disciplined execution, clear tech transfer strategies, strong communication, and experienced teams who have been through scale-up before. The goal isn’t just to manufacture an ADC, but to do it in a way that supports consistent delivery and reduces risk for programmes that matter to patients waiting."

3. How does Pfizer collaborate with external partners and biotech companies to support biologics and ADC manufacturing - from late-stage development through commercial supply?

"We support external companies by combining programme discipline with the specialised capabilities required for complex modalities. Practically, that means aligning early on what ‘good’ looks like for tech transfer and then executing through a defined set of activities - technical transfer, scale-up/validation, regulatory support, CMC preparation, manufacturing and drug product. 

For ADCs, we take a very intentional approach to how work is executed across our sites. North Creek integrates cell culture and conjugation and can progress efficiently into conjugation, while drug product can be supported through the broader network such as at our Pearl River. The goal is to reduce handoffs and compress timelines where it matters, supported by real-time data sharing protocols and direct engagement from site and programme leadership."

4. What emerging trends in biologics and ADC manufacturing (such as single-use technologies, integrated drug substance and drug product, or digitalization) do you believe will shape the industry over the next 5–10 years?

"I think the next decade will be shaped by manufacturing models that allow teams to move faster without losing control, especially for complex modalities like ADCs. We’re already seeing strong momentum around single-use and modular designs, particularly in high containment environments, because they offer the flexibility programmes need as demand and timelines evolve.

At the same time, there’s a clear push toward more integrated approaches that reduce handoffs and simplify execution, whether that’s aligning drug substance and conjugation or bringing key steps closer together. And finally, digitalisation will continue to play a bigger role — not as a replacement for experience, but as a way to support better decisions through tools like PAT and connected data flows. Together, these trends are all about enabling more predictable, efficient paths from development to patients waiting."

5. What unique manufacturing insights and real-world experience will Pfizer bring to the Next-Gen Biologics track, particularly in complex modalities like antibody-drug conjugates?

"What we’ll bring is not theory, it’s hands-on operating experience across the ADC lifecycle. Our teams have decades of combined experience in mammalian cell culture and single-use ADC conjugation, and a history that includes being responsible for the world’s first commercially approved ADC product (Mylotarg™). 

On today’s capabilities, we can speak to what it takes to run ADC programmes with speed and control: segregated single-use conjugation suites, real-time data sharing protocols, digitalised workflows, and QC depth that supports clinical and commercial needs. And we can share concrete operational learnings — for example, North Creek has manufactured over 180 batches since 2018 with a 97% success rate across 17 programmes."

6. How is Pfizer preparing its biologics and ADC manufacturing capabilities to meet growing global demand, while ensuring consistent quality, regulatory compliance, and secure supply chains?

"Demand growth in ADCs is real, and the response has to be practical: capacity that can flex, processes that can transfer efficiently, and systems that support consistent quality. Within Pfizer CentreOne, we’ve focused on developing meaningful scale and specialised capability for ADC manufacturing, supported by in-house quality control that spans in-process testing, release, and stability.

On execution, we lean on structured tech transfer supported by digital infrastructure and PAT, and we operate with global compliance capabilities informed by regulatory knowledge across more than 150 countries. And on supply resilience, we focus on secure supply chain practices, plus site designs and utilities that support continuity — all oriented toward consistent delivery for patients waiting."

7. What key message would Pfizer CentreOne like to share with biotech and pharma leaders attending CPHI Americas 2026?

"The key message is really about confidence and choice. No matter where you are in your journey, whether you’re developing a complex biologic, scaling a sterile injectable, or bringing an oral solid dose product to market… manufacturing shouldn’t be the thing that slows you down.At Pfizer CentreOne, we’re a CMO built to support a wide range of modalities, from ADCs and biologics to sterile injectables and oral solid dose, all backed by deep manufacturing experience and a patient-first mindset. Our focus is on disciplined execution, clear communication, and helping companies navigate the real-world challenges that come with scaling and commercialising therapies.

At CPHI Americas, we’re looking forward to practical conversations - about tech transfer, supply resilience, regulatory readiness, and how modern manufacturing approaches can help programmes move forward with greater confidence. When patients are waiting, time really does matter, and that’s the lens we bring to every discussion."

8. What are you most looking forward to at CPHI Americas 2026?

"For me, the value of events like CPHI is the quality of the conversations, meeting innovators who are making hard decisions about scale, timelines, and risk. I’m looking forward to discussions focused on what actually moves programmes forward: tech transfer clarity, execution at specialised sites, and practical approaches to de-risk supply chains. And I’m proud of what our Pfizer CentreOne teams can share more broadly,  from single-use high containment ADC operations to integrated OSD capabilities, all centred on getting therapies to patients waiting."