Gdańsk, Poland and Berlin, Germany ̶ May 7, 2025
ProBioGen announced today an agreement with Polpharma Biologics, an international biotech company dedicated to the development and manufacture of biosimilars. Under this agreement ProBioGen will conduct high-performance cell line development services for Polpharma's biosimilar candidate, supporting their expanding pipeline.
The biologics industry mantra 'the process defines the product,' underscores the importance of starting with the right cell line. Leveraging its cutting-edge cell line development platform, CHO.RiGHT®, including the proprietary DirectedLuck® transposase technology and decades of expertise in cell line development for new biological entities and biosimilars, ProBioGen will generate a robust, high-yielding production cell line that meets the critical quality attribute profile of Polpharma's biosimilar. This collaboration enhances Polpharma's capacity to meet increasing demands and accelerate its biosimilar pipeline by ensuring high biosimilar quality, stable cell lines, and fast timelines.
"We are excited to support Polpharma Biologics in bringing their product to the clinic," said Dr. Volker Sandig, Chief Scientific Officer at ProBioGen. "By applying our extensive expertise in cell line engineering, we provide Polpharma with best-in-class expression platform that ensures efficiency, expression stability and superior quality."
Dr. Konstantin Matentzoglu, Supervisory Board Member from Polpharma Biologics, added: "Partnering with a reliable CDMO to support our expanding capacity needs was crucial. ProBioGen's track record, proven expertise, agility and dedication to high-standard services were key factors in our decision to collaborate. This partnership reflects the increasing demand for biosimilars and reinforces our commitment to improving patient access while reducing healthcare costs by using high-expressing production cell lines."
With its outstanding cell line development results, ProBioGen remains committed to enabling the rapid and efficient development of biosimilars, aligning perfectly with Polpharma Biologics' mission to provide affordable biologics. The development of biosimilars is a complex process requiring rigorous testing and fine-tuning to ensure they are as safe and effective as the originator biologic. Through this and future collaborations, both companies aim to accelerate development timelines and drive the production of next-generation therapies that address high medical needs.
Further financial details remain undisclosed.
About DirectedLuck® Transposase
ProBioGen's DirectedLuck® transposase system combines an optimized and highly active transposase and transposon with epigenetic targeting. It is equipped with a recognition domain for specific histone marks that integrates multiple copies of transgene expression units individually at genomic regions with highest transcriptional activity. As a result, it achieves exceptionally high protein expression and maximum stability in clone pools and clones. This reduces the time and manual lab work required for selecting superior clones for best titers, proven stability and product quality.
The DirectedLuck Transposase is compatible with genetic elements in standard expression vector design and can be used with host cell lines of different species and tissue origin. DirectedLuck delivers superior cell lines for standard mAbs and complex glycoproteins and provides additional benefits for bispecifics and virus producer cell lines where it allows gradual adjustment of relative expression levels for optimal product quality.
DirectedLuck is available for out-licensing. Furthermore, ProBioGen applies DirectedLuck as a standard tool in clients' service projects at no additional charge.
About Polpharma Biologics
Polpharma Biologics is an international biotechnology company, with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Polpharma Biologics develops biosimilar therapies to treat a range of conditions in major therapeutic areas.
Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production, preparing drugs for future commercial partnerships with global pharmaceutical organizations. Under partnerships agreements, the company manufactures two approved biosimilars from its pipeline; ranibizumab and natalizumab.
With its cell line development center in The Netherlands, and two centers of development and manufacturing in Poland, Polpharma Biologics creates development opportunities for biotechnology specialists.
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About ProBioGen
ProBioGen is a Berlin-based specialist for developing and manufacturing biopharmaceutical active ingredients,
viral vectors and vaccines while applying proprietary technologies to improve product quality and features.
Combining both state-of-the-art development services, based on ProBioGen's CHO.RiGHT® expression and manufacturing platform, together with intelligent product-specific technologies yields biologics with optimized properties. Rapid and integrated cell line and process development, comprehensive analytical development and following reliable GMP manufacturing is performed by a highly skilled and experienced team. All services and technologies are embedded in a total quality management system to assure compliance with GMP standards (EMA/FDA).
ProBioGen has been operational for 30 years. At three locations in Berlin, 300 employees contribute to the creation of new therapies in medicine and groundbreaking innovations worldwide through their creative and meticulous work. ProBioGen's growth strategy is driven by the expansion of the service value chain through organic growth and potential acquisition. Diversification is a complement driver, while the focus remains strictly on enabling the development of biopharmaceuticals for tomorrow.
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