The interview was conducted by and published in “Świat Przemysłu Farmaceutycznego” magazine.
Rezon Bio: Polish experience in the development and manufacture of biological drugs for the global CDMO market
The establishment of Rezon Bio is a clear indicator of the growing maturity of the Polish biotechnology sector. Building on the many years of expertise of the Polpharma Biologics teams, the company is entering the global CDMO market, offering comprehensive support in the development and manufacture of biological drugs. This model combines practical experience gained from its own projects with a flexible approach to cooperation with pharmaceutical and biotechnology companies. Dr. Adriana Kiędzierska-Mencfeld, CEO of the company, discusses Rezon Bio’s strategy, technological infrastructure, process digitization, and ambitions to build a strong position for Poland on the European biotechnology map.
Rezon Bio, which originated from Polpharma Biologics, officially debuted in September. What was the main impetus for establishing Rezon Bio as a separate brand?
Adriana Kiędzierska-Mencfeld, CEO of Rezon Bio: For many years, we have been developing our own biosimilars, building expertise from the research stage through technology development to commercial production. At the same time, we have been investing in laboratory and manufacturing infrastructure. The result is two drugs developed and manufactured in Poland that are now available on many international markets, as well as several additional projects at various stages of development.
However, a model based solely on the development of proprietary molecules has natural limitations in terms of scale and is associated with high risk. Each new proprietary molecule requires nearly ten years of work, which limits the number of programs a company can run in parallel. This is why we decided to expand our capabilities by offering contract development and manufacturing (CDMO) services of biological therapeutics to other biotech and pharmaceutical companies.
What specific services does Rezon Bio offer today?
AKM: We are a biotechnology company that can comprehensively support the development and production of biological molecules, from initial research to full commercial production. We handle all stages of the biological drug manufacturing process, which allows us to conduct projects efficiently, optimize them quickly, and prepare them to meet the regulatory requirements of agencies such as the U.S. FDA and the European Medicines Agency (EMA).
How do you assess market demand for CDMO services in the field of biologics, and how does Rezon Bio respond to these needs?
AKM: Demand on the global market is very high. Companies are increasingly outsourcing development and production due to the high costs and complexity of biological therapies. In 2025, the global market for biological CDMO services was valued at approximately $25 billion and is projected to grow to $36.5 billion by 2030, with an annual growth rate of approximately 7.6%. By launching operations under the CDMO business model at this point, we are responding to these needs because, as a new entity, we can already boast the extensive experience and expertise of our employees. We are not starting from scratch. What is more, we provide full support in the development and manufacture of molecules, combining high quality in line with international standards with cost-efficiency — something that difficult to be achieved. This would not be possible without process optimization and our flexible, individual approach to each customer.
Rezon Bio is built on the many years of expertise of Polpharma Biologics. Which elements of this experience proved to be key in building the new organization?
AKM: First of all, while working on our own biosimilars, we gained practical knowledge of how to run a biological project from start to finish. We understand the importance of process optimization, rapid product launch, and risk minimization, which allows us to effectively support our clients and respond to their needs today.
In addition, we began our journey by using CDMO services ourselves, so we understand first-hand that small and medium-sized companies are often not treated as a priority and rarely receive an tailored . This is why at Rezon Bio we treat each project individually, adapting to the client’s needs. We want even startups and smaller projects to be taken seriously and to be able to count on a quick response and a flexible approach.
We also place great value on the experience of our employees. It is thanks to their expertise that two biological molecules — bioequivalent natalizumab and ranibizumab — were successfully developed, a major achievement, especially given that no biological drugs had previously been produced in Poland. These competencies remain within our team and form the foundation on which we are building Rezon Bio, creating a network of knowledge and experience that will continue to develop within the Polish market.
What role do the centers in Gdańsk and Warsaw–Duchnice play in Rezon Bio’s operations, and what technological capabilities do they offer to customers?
AKM: In Gdańsk, we focus on process development and medium-scale production of clinical and commercial supplies in accordance with GMP principles, tailoring solutions to individual customer needs. Our capabilities also include the development of medicinal product formulations, which are tested for stability in accordance with ICH guidelines developed by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. After the development stage is complete, processes can be scaled up and transferred to GMP-certified facilities or external partners, allowing production to be flexibly adapted to customer requirements.
The Warsaw–Duchnice site, on the other hand, enables the execution of large-scale commercial projects, also in accordance with GMP principles. It is one of the largest and most modern facilities in Europe dedicated to the development and manufacture of biological medicines and is equipped with quality control laboratories for drug substances. In Duchnice, we are increasing our production capacity for drug substances to 2,000 liters, and we also offer single-use bioreactors with capacities ranging from 50 to 500 liters for the production of smaller batches. This allows us to effectively support early-stage clinical trials and the production of orphan drugs intended for the treatment of rare diseases. This provides our clients with flexibility and security throughout the entire production process.
How does the establishment of Rezon Bio affect Poland’s position on the European biotechnology map?
AKM: We will certainly do everything we can to ensure that the biotechnology world turns its attention not only to our company, but also to our country and its biotechnology potential. We hope that, thanks to our global activities, Poland will become a biotechnology hub in this part of Europe. We have highly educated workforce and world-class experts. That is a great strength.
You received the Woman of the Year title in the CPHI Pharma Awards 2025 poll. What does this award mean to you personally and for Rezon Bio as an organization?
AKM: This award is a great honor for me and a very personal confirmation that what we believe in and what we are building at Rezon Bio makes sense. It motivates me to continue strengthening the team, developing employee competencies, and creating an environment that supports the effective implementation of innovation. However, this award is not just for me. Above all, it is a recognition of the entire Rezon Bio team, because every success we achieve is the result of the joint work, commitment, and passion of all our employees. When I returned from Frankfurt and was greeted by acollegues with flowers, I felt enormous pride and emotion. That moment made me realize how strong and committed our team truly is.
The capillary leadership model that you promote has gained recognition from an international jury. How does it translate into the way teams function at Rezon Bio and into cooperation with partners?
AKM: The capillary leadership model, inspired by capillaries, involves decentralizing responsibility and strengthening the autonomy of teams at all levels of the organization. Each team member has a clearly defined role, but also the ability to make decisions within their area of competence, which increases operational efficiency and reduces response times to technical challenges.
In practice, this means faster communication, more efficient problem-solving, and greater flexibility in project management. An important element of this approach is openness to mistakes. We treat them as a natural part of the process—from which we learn and through which we continuously improve our procedures and the quality of our work.
Cooperation with partners also benefits from this model. Thanks to clearly defined responsibilities and transparent processes, we can quickly adapt to client needs while ensuring high quality standards and compliance with regulatory requirements.
What are Rezon Bio’s current priorities?
AKM: Our priority is, above all, to develop partnerships with a growing number of clients, which allows us to expand both our project portfolio and the competencies of our employees. In practice, this means that the more projects we carry out, the more we develop the knowledge and experience of our team and increase our technological capabilities. This, in turn, contributes to strengthening the biotechnology sector in Poland and the country’s economy as a whole.
