Meeting global market challenges
The global biologics industry is entering a new phase of maturity. As costs tighten and timelines accelerate, CDMOs must deliver uncompromised quality while driving efficiency. Rezon Bio, an EU-based biologics CDMO with state-of-the-art facilities and a client-centric approach, was established to meet biotech and pharmaceutical client needs with agility, pragmatism, and trust.
Biologics have transformed treatment for numerous life-threatening conditions such as cancer. With biosimilars accelerating competition, regulators streamlining pathways and pharmaceutical and biotechnology companies demanding affordability, the biologics market is entering a new phase of maturity.
Biologics market in transition
What was once a race for innovation at any cost is now a discipline of efficiency. Speed, quality and cost are no longer trade-offs; they must be delivered in balance. For CDMOs, this means rethinking how projects are developed, transferred and commercialised and how partnerships are structured for long-term success. At the same time, global supply chains are being re-evaluated. Regionalisation, reliability and trust are increasingly valued alongside technical capability. Clients are asking not only if CDMOs can manufacture a product, but also if they are willing to stand by them as pressures increase and markets evolve.
Rezon Bio: small, focused, disruptive
It is within this environment that Rezon Bio was launched, not as a startup without foundations, but as an evolution of Polpharma Biologics’ biosimilars division. With two mirrored facilities in Gdańsk and Warsaw-Duchnice, Rezon Bio offers clients a streamlined path from cell line development through GMP manufacturing to commercial supply. Rezon Bio’s Gdańsk facility is EMA certified and US FDA approved, while its Warsaw-Duchnice site is EMA certified and planned for future FDA licensing.
Both sites were designed with scalability in mind, giving Rezon Bio the ability to expand rapidly to seven GMP lines as client demand grows. This scalability, combined with proven expertise in commercial launches, means Rezon Bio enters the CDMO market with assets and credibility that most new entrants lack. The name itself reflects the company’s philosophy. “Rezon” echoes reason – a commitment to rational, efficient processes that remove chaos from biologics development and manufacturing. It also reflects determination, signalling the drive to create value for clients and their patients.
What truly sets Rezon Bio apart is its people. The company has built a highly educated and experienced workforce, with many employees contributing their expertise for years and carrying invaluable institutional knowledge. This continuity gives clients confidence that projects will be executed with consistency, avoiding the disruptions or repeated mistakes that can arise from frequent turnover.
Pragmatic biologics manufacturing
The biologics market is maturing into a more standardised, efficiency-driven space. For clients, this means they are no longer willing to tolerate uncontrolled costs or unnecessary complexity. They expect reliable delivery, competitive economics and compliance without compromise.
Rezon Bio has been established precisely for this environment. Its GMP systems are robust and fully compliant, ensuring patient safety and regulatory confidence, avoiding the over-engineering that drives costs up without adding value. At the same time, the company’s single-use technology platforms, lean processes, and advanced digitisation enable programs to move from early development to market with speed and reliability. Digital tools, including process modelling and digital twins, further optimise performance and reduce timelines.
An end-to-end CDMO partner
Rezon Bio’s capabilities allow the company to create value across the entire biologics lifecycle, including:
Process development: Modern laboratories and high-throughput systems enable rapid, data-driven optimisation of upstream and downstream processes.
Clinical and Commercial Manufacturing: Flexible, single-use bioreactors ensure scalability and consistency, supported by mirrored sites that provide supply continuity.
Drug Product Capabilities: Integrated in-house teams and established external partners offer formulation, fill-finish and packaging services.
Regulatory Expertise: With successful regulatory approvals already secured, Rezon Bio brings proven experience in navigating global filings, inspections and launches.
The company’s end-to-end capabilities give clients flexibility and the support they need. Whether outsourcing a single stage of development or partnering across the entire journey, Rezon Bio is structured to deliver speed, compliance and cost competitiveness at every step.
The advantage of Poland
Poland’s biotechnology ecosystem is rapidly gaining momentum, positioning the country as a rising force in Central and Eastern Europe. With over 300 biotech companies and a robust, expanding R&D landscape, Poland now covers the full value chain from early-stage research and technology transfer to advanced manufacturing and commercialisation. Anchored by a vibrant network of life sciences hubs in Warsaw, Kraków, Wrocław, Poznań and Gdańsk, and supported by around 40 universities offering biotechnology programmes and over 250 R&D institutions, the country provides a robust foundation for scientific and industrial growth. This academic strength translates into a steady pipeline of highly skilled graduates, fuelling both established companies and a dynamic startup scene.
The country’s competitive advantages – high-quality talent, cost efficiency, strong work ethic, and a growing culture of innovation – are driving rapid progress. As Poland continues to invest in infrastructure, education and international partnerships, it is well positioned to strengthen its role as a regional leader in life sciences and biomanufacturing.
Rezon Bio leverages this momentum, combining the geographic and regulatory advantages of operating in Europe, with Poland’s exceptional talent base and competitive cost structure. This strategic positioning enables the company to deliver high-quality, cost-effective biologics development and manufacturing services without compromise.
Through close collaboration with leading universities, robust apprenticeship programmes and ongoing internal training, Rezon Bio has cultivated a workforce that blends global biopharma expertise with local ambition and resilience. The company’s teams consistently go the extra mile for clients, bringing technical excellence and a client-centric mindset that translates into real value across every project.
From Polpharma to Rezon Bio
With roots dating back to 1935, when Polpharma was founded in Poland, the company’s heritage is built on nearly a century of scientific excellence, quality and innovation. Under the ownership of visionary entrepreneur Jerzy Starak since 2000, the company has transformed from a national pharmaceutical company into a global biotechnology leader. The opening of the first biotech R&D centre in Gdańsk in 2012, the acquisition of Bioceros BV in 2016, and the establishment of the state-of-the-art Warsaw-Duchnice manufacturing site in 2018 laid the foundations for this transformation. In 2019, Polpharma Biologics was formally spun off from Polpharma, establishing itself as an independent entity focused on biosimilars and biologics innovation. In 2025, Polpharma Biologics underwent a major transformation, splitting into two independent entities: the biosimilars business relocated to Switzerland to operate under the original brand, while the CDMO operations in Poland were rebranded as Rezon Bio. This strategic evolution is powered by 90 years of scientific excellence and the vision of a committed founder.
In today’s competitive outsourcing landscape, smaller mid-sized biotech companies often struggle to secure the attention they need from the largest CDMOs. Too frequently these innovators are treated as “filler projects”, slotted into idle capacity or deprioritised when larger, more lucrative contracts come along. This creates uncertainty, delays and risks for companies whose programs are highly time-sensitive and resource constrained. Rezon Bio addresses this gap by providing smaller “innovators with the same level of commitment as larger firms enjoy. Positioned as a mid-sized CDMO, the company is structured to offer flexibility, responsiveness and direct access to senior scientific and operational leadership.
Looking ahead
As the biologics sector matures, success increasingly depends on efficiency, reliability, and trust. Rezon Bio enters this new chapter with a rare combination of world-class facilities, regulatory approvals, and a workforce whose dedication consistently delivers value. By uniting European standards with Poland’s cost advantages and scientific talent, the company offers excellence without compromise.
More than a service provider, Rezon Bio positions itself as a true partner that treats every programme with ownership, transparency, and urgency. For innovators seeking to bring life-changing therapies to patients faster and more sustainably, Rezon Bio represents a new kind of CDMO, efficient by design, driven by excellence, and built on the belief that dedication creates lasting value.
About Rezon Bio
Rezon Bio is a biologics CDMO specialising in mammalian drug substance development and GMP manufacturing, with drug product coordinated via qualified external partners. Headquartered in Poland, the company operates two mirrored-capability facilities in Gdańsk and Warsaw-Duchnice audited by EMA and FDA. Drawing on a legacy of biosimilars development and global commercialisation, Rezon Bio combines proven experience, digital transparency, and cost-to-value efficiency to help clients move from concept to market with confidence. Learn more at www.rezonbio.com or contact us at bd@rezonbio.com.
Contact:
Rezon Bio
ul. Trzy Lipy 3
80-172 Gdańsk, Poland
www.rezonbio.com
This advertorial was published in Special CDMOs & CROs, part of European Biotechnology Magazine Autumn 2025.
Rezon Bio
Polpharma Biologics SA