Rezon Bio emerged from Polpharma Biologics as a dedicated clinical-to-commercial scale-up biologics CDMO in the fall of 2025. Yet, a new name doesn’t mean “newcomer”. Our recently appointed COO, Dr. Ralf Otto, who brings more than two decades of experience spanning CDMO operations at Boehringer Ingelheim, and Rentschler Biopharma and strategy consulting at McKinsey, sat down to explain our biologics CDMO track record.
Key Takeaways
- Rezon Bio was established in fall 2025 as a dedicated European biologics CDMO, building on the long-standing scientific and manufacturing expertise of Polpharma Biologics. With over 1100 employees, it brings decades of biologics expertise and operational experience brings decades of biologics expertise and operational experience.
- It has an existing track record of supporting leading biopharmaceutical, biosimilar and biotech companies, from production process and analytical development through clinical and commercial manufacturing.
- It has two FDA- and EMA-approved facilities in Poland (Gdańsk and Duchnice).
- New COO, Dr. Ralf Otto brings 25 years of experience across the CDMO industry, including C-suite executive roles at Boehringer Ingelheim and Rentschler Biopharma, as well as 10 years at McKinsey & Company, where he led the global Life Sciences Services (LSS) practice serving more than 25 CDMOs worldwide.
Can you talk through your career to date? How did you end up in biologics CDMO leadership?
I have a hybrid background that combines around 15 years in the CDMO industry with 10 years in strategy consulting. That combination has allowed me to see the biologics industry from both sides, building and leading contract manufacturing organizations, and later advising life sciences companies and CDMOs on strategy, operational excellence and transformation.
A significant part of my industry career was spent at Boehringer Ingelheim, where I joined during the construction of what was then the world’s largest mammalian cell culture facility with six 15,000L and four 2,000L single-use capacity. I started as a Lab Manager in cell biology in process development, and soon became the Plant Manager of one of their large-scale mammalian cell culture facility (up to 15,000L bioreactor scale).
Scaling at that pace meant hiring and training hundreds of employees, securing the client portfolio to utilize the new capacity, and building the operational excellence required to support both clinical and commercial manufacturing across the product lifecycle. Experiencing that journey firsthand gave me invaluable insight into what it takes to successfully scale a biologics CDMO.
As the business continued to grow, I joined the negotiation team for Boehringer Ingelheim’s acquisition of an Amgen site in the Bay Area. Following the acquisition I became General Manager and Site Head and relocated with my family to lead its integration and transformation. We expanded the product portfolio tenfold, established the production process development area, and despite extensive changes to business processes, successfully passed an unannounced six-week FDA inspection with zero 483s. That experience reinforced what it takes to transform manufacturing capabilities into a client-focused CDMO business.
Next, McKinsey & Company asked me to join, where I became an elected Partner and built the bio-manufacturing service line, focusing on biologics like monoclonal antibodies, while designing a benchmark for strategic biopharma operational transformation. Over time, I built the Life Sciences Services (LSS) practice and was twice elected Global Practice Leader, advising more than 25 CDMOs worldwide. Together with my team, we developed global benchmarking and customer satisfaction (NPS) capabilities for the CDMO industry that enabled companies to benchmark their operational performance, customer experience, and competitive positioning.
In between the two tenures at McKinsey, I joined the family-run Rentschler Biopharma as COO, where I had the opportunity to lead another major transformation. Together with leaders and employees, we evolved the company into a client-oriented, multi-product biologics CDMO. By implementing lean optimization, streamlining business development and commercial operations, we significantly increase productivity and established the capabilities required to serve a diverse CDMO client base. We also acquired a site from Takeda/Shire near Boston, and I was President and CEO during the integration phase of the Rentschler Biopharma Inc.
During my time as a Strategy Consultant, I also worked with Polpharma Biologics – now Rezon Bio – helping with strategy and leadership coaching. And when the idea came up, why not join? I felt honored when I was asked, honestly, because you can walk the talk. You helped with the strategy, you helped with coaching, and now I can lead the team.”
On joining Rezon Bio: “I felt honored when I was asked, honestly, because you can walk the talk. You helped with the strategy, you helped with coaching, and now I can lead the team.” — Dr. Ralf Otto
What is Rezon Bio’s track record as a biologics CDMO?
Rezon Bio has built a solid track record of developing and producing biologics for clients ranging from top 10 global pharmaceutical companies and top three of the world’s leading biosimilar developers to innovative biotechnology companies, from launch through commercialization. We operate two large FDA- and EMA-approved facilities in Poland: one in Gdańsk and one in Duchnice, near Warsaw.
Despite this, there is too much of an impression that Rezon Bio is a newcomer. We are not a newcomer. The Rezon Bio name is new, but the scientific expertise, manufacturing know-how, and proven CDMO capabilities developed within Polpharma Biologics remain the same. We offer multiple service packages defined across early development, late development, technology transfer, and production, with a ‘service competitiveness team’ of thirty people focused entirely on delivery timelines and operational performance.
And for new biologics entity (NBE) biotech clients: we have been a biotech ourselves. We have been in their shoes. The way we communicate with them is with the right mindset. We also understand how important it is to do a smaller batch size, a short campaign. This experience shapes how we work with clients every day.”
On Rezon Bio as a newcomer: “We are not a newcomer. The Rezon Bio name is new, but the scientific expertise, manufacturing know-how, and proven CDMO capabilities developed within Polpharma Biologics remain the same.” – Dr. Ralf Otto
What’s the first thing you set out to do at Rezon Bio?
First, I want to dispel the newcomer myth. We are built on an established track record. While the Rezon Bio name is new, the business, the people and the experience are not. We already work with leading biosimilar and biologics clients, and I believe our growing leadership team will further reinforce that credibility.
The second priority is growth. We aim to help more clients with end-to-end services, from early development to commercial, while expanding even more towards diverse biomodalities, broadening and hedging our portfolio.
What’s changing at Rezon Bio right now?
One of our priorities has been strengthening the leadership team to support Rezon Bio’s next phase of growth. We’ve established a clear executive structure where I effectively act as a ‘Chief Service Officer’, covering service competitiveness, development, manufacturing, engineering, quality, and integrated supply chain.
We’ve also recently welcomed our new Chief Business Officer (CBO), Hubert Scholze, who brings extensive commercial leadership CDMO experience, as well as our Vice President of Strategy & Technology, Cornelius Klöck, whose strategic expertise provides deep insights into the global life sciences and CDMO market. But we’re doing these appointments with a ‘crystallization core’ mindset, bringing in a small number of experienced CDMO leaders to strengthen the organization while continuing to develop the exceptional talent we already have in Poland. It’s about building on our existing strengths, not replacing them.
Two years from now, what do you hope for Rezon Bio to achieve?
In two years, I want Rezon Bio to be the partner of choice for companies looking for a price-competitive, integrated European biologics CDMO. We already have strong scientific expertise, manufacturing capabilities and regulatory track record. Our ambition is to build on those strengths and become the preferred partner for clients seeking the ideal combination of very competitive economics, world-class science, proven quality and reliability in FDA- and EMA-approved facilities, operational excellence and a long-term partnership backed by a strong, stable organization with sustained investment in growth.
We want to continue expanding our client portfolio across biosimilars and new biological entities (NBEs), including special complex proteins, supporting partners through our integrated service offering, from process and analytical development, technology transfer, MSAT and PPQ to clinical and commercial GMP manufacturing, quality assurance and regulatory support.
The CDMO market is evolving rapidly. Clients increasingly expect more than manufacturing capacity. They are looking for scientific expertise, price-competitiveness, speed, digital and AI-enabled capabilities, supply chain resilience, and partners who are committed to their long-term success. That’s exactly where we are investing, continuously strengthening our people, our technologies, and the way we operate.We aim to further improve our operating model through greater efficiency, empowered teams, agility, and increased productivity. Additionally, we will continue developing exceptional talent in Poland, while selectively bringing experienced CDMO leaders who can help accelerate capability building, and develop the next generation of leaders within Rezon Bio.
We have a really nice cross-fertilizing setup within the Polpharma Group we are part of. We benefit from close interactions with the biosimilars business and the innovator part with JJP Biologics. With Rezon Bio, we have excellence in biosimilars and biologics development and manufacturing. While Poland may not yet be the first country that comes to mind for biologics outsourcing, we see this as an opportunity. By combining this unique ecosystem with world-class science, regulatory credibility and price-competitiveness, we are building a differentiated European biologics CDMO that is here for long term. This cross-fertilizing setup strengthens our capabilities and accelerates innovation across biosimilars, NBEs and operations. It also enables us to develop talent internally, and build a sustainable pipeline of expertise, reducing our dependence on the relatively limited talent pool available in Poland.
We have the opportunity to offer something that is increasingly rare in today’s market: world-class science, FDA- and EMA-approved quality, and the price competitiveness and speed clients need to bring more biologics to patients. That’s a combination we’re proud of, and one that will continue to set Rezon Bio apart.
Considering Rezon Bio for your next biologics program? Talk to our team about your development or manufacturing needs and see our track record for yourself.
About Dr. Ralf Otto
Dr. Ralf Otto is Chief Operating Officer at Rezon Bio, joining in 2026 with two decades of biologics CDMO leadership. He holds a PhD in Biotechnology and began his career at Henkel before moving into CDMO operations at Boehringer Ingelheim, where he helped pioneer the company’s entry into contract manufacturing and led the transformation of a former Amgen site in the Bay Area. He later became a twice-elected Partner at McKinsey, building its global life sciences services practice, before serving as COO of Rentschler Biopharma Inc. At Rezon Bio as COO, he oversees development, cGMP manufacturing, engineering, and service competitiveness.
References
- Bleys, J., Ream, S. & Ehlert, F. (2026). How customer expectations are reshaping the CDMO market. McKinsey & Company. [Internet]. [cited 2026, Aug 3]. Available from: https://www.mckinsey.com/industries/life-sciences/our-insights/the-synthesis/how-customer-expectations-are-reshaping-the-cdmo-market
