ProBioGen, Zag Bio ink CMC partnership to support autoimmune therapy
ProBioGen, a contract development and manufacturing organization (CDMO) headquartered in Berlin, Germany, has signed a service agreement with Zag Bio, a U.S.-based biotechnology company developing thymus-targeted therapies to support the development of an Fc-fusion protein candidate for autoimmune disease.
Under the initial scope of work, ProBioGen will provide cell line development, process development, and GMP manufacturing services for Zag Bio’s lead product candidate, ZAG-101, which is being developed for the prevention or delay of Type 1 diabetes. The companies said the program is targeted to enter clinical development in the second half of 2026.
According to the announcement, ProBioGen will develop a production cell line using its proprietary CHO-based expression system, along with the parallel evaluation of multiple candidate constructs, to support a data-driven selection of a clinical candidate while maintaining an accelerated development timeline.
“This agreement … marks the beginning of a collaborative effort to bring Zag Bio’s highly innovative thymus-targeted bifunctional antibody program to life,” ProBioGen CEO Alfred Merz said in a statement. “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.”
Zag Bio said the partnership is intended to establish a scalable manufacturing pathway aligned with regulatory and quality expectations as the program advances toward clinical testing.
“We chose ProBioGen not just for their scientific excellence, but for their reputation as a truly collaborative and flexible partner,” Zag Bio CEO Jason Cole said in a statement. “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.”
Financial terms of the agreement were not disclosed.