ProBioGen and Zag Bio™ Forge Strategic CMC Partnership to Advance Fc-Fusion Autoimmune Therapy

BERLIN, Germany, January 06, 2026 / Biotech Newswire / -- ProBioGen announced today the signing of a Master Service Agreement ("MSA") with Zag Bio, Inc., a biotechnology company developing thymus-targeted therapies to induce central immune tolerance. Under the MSA’s first integrated service package, ProBioGen will provide cell line development, process development, and GMP manufacturing for Zag Bio's lead ZAG-101 product candidate for the prevention or delay of Type 1 diabetes, targeted to enter clinical development in the second half of 2026. ProBioGen conducts cell line development based on its CHO.RiGHT® expression platform, applying its proprietary DirectedLuck® transposase technology. This highly efficient gene delivery and expression system aims to deliver the most productive and robust cell line, and together with its unique PsiBot smart automation solution, allows faster selection of producer clones with superior quality. The integrated approach not only accelerates early development but lays a strong foundation for scalable, high-yield manufacturing aligned with regulatory and quality expectations.

To speed up the program and support risk mitigation simultaneously, the process includes a parallel assessment of multiple candidate constructs. Such an approach enables rapid, data-driven selection of the optimal clinical candidate while maintaining an accelerated timeline.

"This agreement is more than a contractual milestone. It marks the beginning of a collaborative effort to bring Zag Bio’s highly innovative thymus-targeted bifunctional antibody program to life," said Dr. Alfred Merz, Chief Executive Officer at ProBioGen. "Our integrated platform combines cutting-edge technologies, harmonized automated workflows, and cross-functional expertise, across development and manufacturing, to accelerate our partner's biologics programs with precision and flexibility."

"We chose ProBioGen not just for their scientific excellence, but for their reputation as a truly collaborative and flexible partner", added Jason Cole, Chief Executive Officer, at Zag Bio, "They  impressed us with their deep understanding and integrated capabilities in Fc-fusion protein development, which will enable the manufacturing and clinical development of our lead ZAG-101 molecule, to potentially  deliver transformative impact to patients with Type 1 diabetes and over time, additional autoimmune diseases."

The MSA brings together ProBioGen's development and manufacturing excellence and Zag Bio's scientific innovation, establishing a streamlined and scalable path for next-generation antibody-based therapies aimed at reshaping the autoimmune disease treatment landscape.  

Financial details of the agreement were not disclosed.



Semantic keywords: International Cooperation; Cell Line; Cell Line Development; Cell Proliferation; Cell Culture Techniques; Culture Media; Recombinant Proteins; Productivity; Biological Products; Diabetes Mellitus, Type 1; Germany; ProBioGen; Zag Bio; CMC partnership; Master Service Agreement; Fc-fusion autoimmune therapy; cell line development; process development; GMP manufacturing; ZAG-101; thymus-targeted therapies; CHO.RiGHT® expression platform; DirectedLuck® transposase technology; gene delivery; gene expression; PsiBot smart automation; scalable manufacturing; high-yield manufacturing; automated workflows; Fc-fusion protein development

About DirectedLuck
ProBioGen's DirectedLuck transposase system combines an optimized, 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 the 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 that deliver the best titers, proven stability and high 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. It 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 extra charge.

About PsiBot Smart Automation Solution
ProBioGen's PsiBot smart automation solution is an intelligent, modular approach, built around the Biomek i7 robotic system, seamlessly integrating the screening of large clone panels with deep analytical insight. From 384-well plates through early fed-batch processes, it enables monitoring of cell viability, metabolite profiles, and titers, as well as the analysis of critical product quality attributes such as heterodimer levels or biosimilarity. Unlike conventional approaches, it prioritizes product quality and process platform fit from the start – making clone selection more predictive, scalable, and manufacturing-ready. When combined with ProBioGen's CHO.RiGHT cell line and high-performing DirectedLuck transposase system, the PsiBot smart automation solution consistently delivers clones that achieve exceptional titers and meet stringent quality criteria — even before full process optimization.

About Zag Bio™
Zag Bio™ has discovered a novel approach to create thymus-targeted medicines to treat and prevent autoimmune diseases by restoring central immune tolerance. Zag Bio designs bifunctional antibodies that deliver self-antigens to antigen-presenting cells in the thymus to harness the body’s natural process for training immune cells to recognize and tolerate self, halting or preventing autoimmune attacks on the body’s own tissues. Zag Bio’s pipeline includes ZAG-101, its lead program for Type 1 diabetes, as well as discovery programs for thymus-targeted therapies to address other autoimmune diseases and help patients and their caregivers. Located in Cambridge, Massachusetts, Zag Bio’s team includes experienced experts in thymus biology, autoimmune diseases and innovative drug development. Zag Bio is supported by a broad syndicate of investors, including Polaris Partners, Mission BioCapital, AbbVie Ventures, the T1D Fund, Lightspeed Ventures, Sanofi Ventures, KdT Ventures, Regeneron Ventures, Boxer Capital, Pear VC, Codon Capital, Alexandria Venture Investments and Gaingels.
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About ProBioGen
ProBioGen is a Berlin-based expert in the development and manufacturing of biopharmaceuticals, viral vectors, and vaccines, powered by proprietary technologies that enhance product quality and features. Its CHO.RiGHT platform enables fast, integrated cell line and process development, comprehensive analytics, and reliable GMP-compliant manufacturing, all supported by a highly experienced team. Operating for over 30 years, ProBioGen runs three manufacturing lines in Berlin, where 300 employees contribute to advancing next-generation therapies and global biotech innovation. The company’s growth strategy focuses on expanding its service value chain through organic growth and strategic opportunities, with a clear mission to enable tomorrow’s biopharmaceuticals.
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