What 3 Principles Guide Merck's Biologics and ADC Capacity Placement?

Dave Maraldo, PhD, executive vice president and president of the Merck Manufacturing Division, discusses how Merck decides where to place new manufacturing capacity in an interview with BioPharm International®. He explains that biologics, antibody-drug conjugates (ADCs), and other complex modalities increasingly blur together on the same platforms, which complicates those decisions.

Dr Maraldo says Merck's manufacturing network design relative to technology rests on 3 principles, which, together, shape how Merck places capacity for each technology. The first principle is geographic placement relative to the patients and the markets the company serves. The second is co-localization of like technologies. He cites biologics manufacturing in Wilmington, Delaware, which is set to become a center of excellence, so Merck can build the requisite knowledge base, achieve economies of scale, and put like things together as it configures the network.¹ Merck operates vaccines, biologics, and small molecule plants. The third principle is harmonization, which Merck will pursue wherever an opportunity exists, according to Dr. Maraldo.

How could end-to-end ADC supply chains change manufacturing investment?

Dr Maraldo posits an end-to-end ADC supply chain as a future potential example of capacity harmonization. In an ADC supply chain, the drug linker is a small molecule process, while the monoclonal antibody and drug conjugation steps are more biologically inclined. A sterile filling operation then persists across all 3 modalities, he says.

An investment in such a chain may push companies past the traditional choice of building for a modality and toward building for a platform or a product family, he explains. "I think that's the maturing that's happening, at least in my way of thinking, as we move through some of these more complex molecules," Dr Maraldo notes.

He also states that a time may come when Merck recognizes the opportunity or chooses to invest in such a chain. He frames this notion as a possible future scenario rather than a current plan for the company.

To gain more insight on Merck, watch an exclusive interview with Dr Maraldo on Pharmaceutical Executive, a sister publication to BioPharm International under MJH Life Sciences.

Reference

1. Merck. Merck breaks ground on new $1 billion biologics center of excellence in Wilmington, Delaware. Press release. Published April 29, 2025. Accessed November 12, 2026. https://www.merck.com/news/merck-breaks-ground-on-new-1-billion-biologics-center-of-excellence-in-wilmington-delaware/

About the speaker

Dave Maraldo, PhD, Executive Vice President and President, Merck Manufacturing Division

Dr Maraldo has responsibility for Merck’s worldwide human health manufacturing and supply operations across a global network of sites for pharmaceuticals, vaccines and biologics. Since joining the company as a project engineer in 1999, he progressed through a range of leadership roles across manufacturing, technical operations, commercialization, and integrated development and supply. Building on that foundation, he led global biologics operations from 2022-2025 and most recently served as senior vice president of human health manufacturing. Dr Maraldo earned his PhD and master of chemical engineering degrees from Drexel University, an MBA degree from Lehigh University, and a bachelor of chemical engineering degree from Widener University.