BERLIN, Germany, April 17, 2025 / Biotech Newswire / -- ProBioGen recognizes the significance of the commercial availability of Ziihera® (zanidatamab-hrii), a therapeutic antibody developed using ProBioGen's proprietary GlymaxX® technology. In addition, ProBioGen also developed the superior cell line and applied its proprietary media for this antibody. Following FDA approval late last year for the treatment of HER2-positive biliary tract cancer (BTC), this milestone underscores the impact of GlymaxX in advancing innovative biologics and represents a step forward in targeted cancer therapy. A GlymaxX modified cell line can be flexibly used to produce differently fucosylated products, depending on the upstream process: In conjunction with fucose-free medium the antibody is literally afucosylated.
"The market availability of a bispecific therapeutic antibody developed with the GlymaxX technology represents an important milestone," said Dr. Gabriele Schneider, Chief Business Officer at ProBioGen. "It is rewarding to see our technology play a role in therapies that can make a real difference for patients. We are proud to have contributed to Ziihera's journey by providing our cell line, media, and our proprietary technology to help bring this innovative treatment to market. We look forward to continuing to support groundbreaking advancements in biopharmaceuticals."
As precision medicine continues to evolve, ProBioGen remains dedicated to supporting biopharma innovators through cutting-edge technologies and tailored services that drive therapeutic success - with further GlymaxX-enabled achievements expected in the near future.
Financial details were not disclosed.
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About GlymaxX
ProBioGen developed the GlymaxX® technology to optimize antibody activity, notably the enhanced antibody-mediated cell killing of cancerous or infected cells (known as "ADCC" activity). GlymaxX is based on the stable introduction of a gene into producer cells that encodes for an enzyme that blocks the cells' fucose biosynthesis pathway and hence the formation of the sugar "fucose". Consequently, in the antibody-producer cells no fucose is added to the antibody's N-linked carbohydrate part. This absence of fucose in antibodies is known to greatly enhance ADCC.
As a unique feature, differentiating it from other approaches, GlymaxX can be applied to both novel or already existing antibody producer cell lines, and entire antibody expression and discovery platforms. GlymaxX does not negatively affect cellular productivity or other product characteristics. Furthermore, a GlymaxX cell line can be flexibly used to produce differently fucosylated products, depending on the upstream process: In fucose-free medium the antibody is literally afucosylated.
The same GlymaxX cell line grown in fucose-containing medium however, uses the provided fucose and produces fully fucosylated antibody. Thus, one GlymaxX cell line can be employed to produce several products: For instance differently fucosylated products, ADCC-enhanced GlymaxX antibodies or wildtype-like, fully fucosylated mAbs, e. g. for a parallel Antibody-Drug-Conjugate (ADC) project. Moreover, GlymaxX has also been used to adjust the fucose level as wanted and by biosimilar-developing companies to match the originators glycoprofile. Overall, GlymaxX is simple, rapid, potent, and universally applicable to different CHO hosts and all other eukaryotic cell species. ProBioGen offers its GlymaxX technology royalty-free and non-exclusively as a service or as an individual license.
About ProBioGen
ProBioGen is a Berlin-based specialist for developing and manufacturing biopharmaceutical active ingredients, viral vectors and vaccines with 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 more than 30 years. At four 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 is strict on enabling the development of biopharmaceuticals for tomorrow.
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Contacts
ProBioGen
Dr. Gabriele Schneider
Chief Business Officer
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ProBioGen Press Contact
Sarah Wandrey
Senior Communications Manager
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Keywords: Drug Discovery; Cell Line; Cell Proliferation; Cell Line Development; Cells, Cultured; Recombinant Proteins; Biological Products; Glycoproteins; Antibodies; Productivity; Antibody-Dependent Cell Cytotoxicity; Fucose; Glycosylation; Technology; Commerce; Germany; GlymaxX®; Antibody; Commercial availability; Cancer therapy; Ziihera®; Zanidatamab-hrii; ProBioGen; Proprietary media; FDA approval; HER2-positive; Biliary tract cancer (BTC); Targeted therapy; Fucosylation; Afucosylated antibody; Bispecific antibody; Dr. Gabriele Schneider; Precision medicine; ADCC (Antibody-Dependent Cellular Cytotoxicity); Fucose biosynthesis; N-linked carbohydrate; Antibody-producer cells; Antibody expression; Cellular productivity; Antibody-Drug Conjugate (ADC); Glycoprofile;CHO.RiGHT® platform
Source: Biotech Newswire