Dr. Adriana Kiędzierska-Mencfeld, CEO, Rezon Bio, in conversation with Unmesh Lal, Vice President, Frost & Sullivan
As pharmaceutical companies seek greater flexibility in biologics development and manufacturing, CDMOs are increasingly expected to provide more than technical capabilities. Cost efficiency, regulatory experience, manufacturing reliability, regional capacity, and the ability to manage development risk are becoming increasingly important when companies select a long-term partner.
For Rezon Bio CEO Dr. Adriana Kiędzierska-Mencfeld, these priorities are shaped by direct experience across the biologics value chain. Her career has included protein engineering, biosimilar development, process scale-up, Good Manufacturing Practices (GMP) manufacturing, regulatory approvals, commercialization, and the challenges of relying on external Contract Development and Manufacturing Organizations (CDMOs). Those experiences ultimately shaped Rezon Bio’s strategy: combining deep technical expertise gained through the development and commercialization of biologics with a flexible CDMO model focused on reducing risk, accelerating timelines, improving cost competitiveness, and supporting customers from early development through commercial manufacturing
In this Transformational Growth Leadership discussion, Unmesh Lal, Vice President, Frost & Sullivan, speaks with Dr. Adriana Kiędzierska-Mencfeld about Rezon Bio’s evolution, its focus on biosimilars and novel biologics, the importance of regional manufacturing, price competitiveness, technology adoption, partnerships, and the company’s ambition to become a reliable CDMO partner for pharmaceutical and biotechnology companies.
The interview was conducted by and published in Frost & Sullivan. Below we present selected excerpts from it. The full article is available here
From Scientific Expertise to Building a Biologics Ecosystem
Unmesh Lal: Before we get into Rezon Bio’s strategy, could you tell us a little about your own journey and how your experience shaped the way you think about biologics development and manufacturing?
Dr. Adriana Kiędzierska-Mencfeld: I am a biochemist by training, and throughout my career I have worked across every stage of the biologics value chain. My background spans protein engineering, biosimilar development, process scale-up, GMP manufacturing, regulatory approvals, commercialization, and executive leadership.
What makes this journey particularly valuable is that I have experienced biologics development from multiple perspectives: as a scientist, an operator, a developer, a manufacturer, and ultimately a business leader responsible for bringing products to market for our clients and their patients. Those experiences taught me that scientific success alone is not enough. The real challenge is translating innovation into commercially viable products that reach patients efficiently and sustainably.
A successful CDMO is not defined by manufacturing capacity alone. It is defined by its ability to understand risk, reduce complexity, and help customers bring competitive biologics to patients.
Turning the Challenges of Outsourcing into a CDMO Model
Unmesh Lal: You have experienced the development journey from the customer side as well as the manufacturing side. How did those experiences influence the creation of Rezon Bio?
Dr. Adriana Kiędzierska-Mencfeld: Our decision to build the CDMO business came from our own experience as a biotech company. When we were a smaller company, we experienced first-hand some of the challenges of outsourcing critical development and manufacturing activities. As a smaller customer, are not always the highest priority, yet the quality, timelines and reliability of that work can have a significant impact on your development program. That experience led us to build those competencies internally and invest in our own development and manufacturing infrastructure.
Over time, we took our biologics programs through clinical development and into commercialization. In doing so, we built not only facilities, but also a highly experienced team and capabilities across development, manufacturing, analytics, quality and regulatory activities.
At one point, we reached a point where the capacity and capabilities we had built exceeded the needs of our own biosimilar pipeline. Biosimilar development is long and capital-intensive process, so there is a natural limit to how quickly products can utilize that infrastructure.
That created a clear strategic opportunity. By separating the businesses, the biosimilar company can remain focused on developing and commercializing its own portfolio, while our Polish sites can operate as a dedicated CDMO and make those capabilities available to external customers.
What is particularly important is that we approach CDMO partnerships with the perspective of someone who has been on the client side. We understand how important responsiveness, transparency and execution are when you are entrusting a partner with a critical part of your development program.
Building a CDMO Around Risk Sharing
Unmesh Lal: That experience seems to have given you a different perspective on what customers actually need from a CDMO. How do you think about the role of the CDMO today?
Dr. Adriana Kiędzierska-Mencfeld: For us, it is about understanding the risks from the beginning. We know what customers struggle with because we experienced many of those challenges ourselves. We also know how critical cost can become later in development if it is not considered early enough.
If you think about cost only at the end, it can become much more expensive, particularly when changes are required after approval. So, we focus on increasing efficiency, reducing cost, improving yield, and minimizing the time and risk associated with development.
Today, a successful CDMO must deliver much more than technical expertise. Customers expect a partner that understands development, regulatory, operational and commercial risk, and proactively helps manage those risks throughout the product lifecycle.
We often say that a CDMO should be prepared to share risk with its customers. However, before you can share risk, you first have to understand it. That understanding comes from firsthand experience of developing, scaling, manufacturing and commercializing biologics. This perspective enables us to challenge assumptions early, identify potential bottlenecks and create solutions that improve long-term outcomes for our customers.
Today, a successful CDMO must deliver much more than technical expertise. Customers expect a partner that understands development, regulatory, operational and commercial risk, and proactively helps manage those risks throughout the product lifecycle.
From Capacity to a Flexible, Customer-focused Model
Unmesh Lal: What does that philosophy mean for the way you are positioning Rezon Bio as a CDMO?
Dr. Adriana Kiędzierska-Mencfeld: Our first objective is to be recognized as a CDMO brand and as a reliable partner, not simply as a biosimilar developer or manufacturer.
We are building the company as a price-competitive and trusted partner, primarily for mid-sized biotechnology companies, while also supporting startups and larger pharmaceutical companies. Mid-sized biotech is our primary focus because we believe our capabilities fit their requirements particularly well, but we also have experience working with larger organizations.
We can support startups because we understand what it means to be at an early stage, but startups are not our only focus because our knowledge and experience extend well beyond early development and into late-stage development and commercialization. One of our key strengths is the ability to support customers as their products progress, from clinical to commercial manufacturing, while maintaining a strong focus on speed, scalability, and cost throughout that journey.
About Rezon Bio
Rezon Bio is a science-driven, integrated CDMO specializing in the development and manufacturing of mammalian biologics. Headquartered in Poland, Rezon Bio offers integrated solutions spanning cell line, process and analytical development, clinical and commercial drug substance manufacturing, and drug product development. The company operates with state-of-the-art facilities, world-class teams, and a proven track record of regulatory and commercial success. Drawing on a legacy of biosimilars development and global commercialization, Rezon Bio combines experience, digital transparency, and cost-to-value efficiency to help clients move from concept to market with confidence.
