CMC partnership advances Fc-fusion autoimmune therapy

ProBioGen has entered a Master Service Agreement with Zag Bio™ to accelerate the development of Zag Bio’s lead Fc-fusion candidate, ZAG-101, aimed at preventing or delaying Type 1 diabetes. Under the agreement, ProBioGen will provide cell line development, process optimisation, and GMP manufacturing, combining its cutting-edge technologies with Zag Bio’s thymus-targeted therapeutic approach.

Using ProBioGen’s CHO.RiGHT® expression platform and proprietary DirectedLuck® transposase technology, the collaboration focuses on generating robust, high-yield cell lines. Integration with ProBioGen’s PsiBot smart automation solution enables rapid selection of optimal producer clones while maintaining superior quality, laying the foundation for scalable, regulatory-compliant manufacturing.

The process includes parallel evaluation of multiple candidate constructs, supporting data-driven selection of the best clinical candidate and minimising development risk. The partnership brings together ProBioGen’s expertise in biologics development and GMP manufacturing with Zag Bio’s innovative bifunctional antibody pipeline, designed to restore immune tolerance and treat autoimmune diseases.

“This collaboration is more than a service agreement — it represents a shared commitment to advancing next-generation therapeutics for autoimmune disease,” said Dr  Alfred Merz, CEO of ProBioGen. “By combining our integrated platforms, automation, and analytical capabilities with Zag Bio’s innovative science, we can accelerate development while maintaining the highest quality standards.”

Jason Cole, CEO of Zag Bio, added: “ProBioGen’s scientific excellence and flexible, collaborative approach make them the ideal partner to bring ZAG-101 toward clinical development and, ultimately, to patients in need.”

With this strategic partnership, ProBioGen and Zag Bio are paving the way for faster, more efficient development of transformative autoimmune therapies, supporting innovation from early research through clinical production.

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