- ERU becomes the first and only public institution in Türkiye authorized to manufacture exosomes for clinical use, offering promising potential for tissue repair and cell regeneration

- Rector Altun: “We are experiencing a historic moment of pride, not only for our university but also for our country’s healthcare vision”

September 6, 2026

Erciyes University (ERU) has become the first and only public institution in Türkiye to receive authorization from the Ministry of Health to manufacture exosomes for clinical use, an emerging technology with promising potential for innovative treatments aimed at tissue repair and cell regeneration.

With the “Manufacturing Site Authorization Certificate” issued by the Turkish Medicines and Medical Devices Agency (TITCK) under the Ministry of Health, the university’s Betül-Ziya Eren Genome and Stem Cell Center (GENKOK) has been authorized to manufacture “umbilical cord-derived mesenchymal stem cell exosomes.”

Exosomes are among the biological structures that carry biological information between cells and hold significant promise, particularly for treatments aimed at tissue repair and cell regeneration.

In assessments conducted by TITCK, GENKOK’s manufacturing areas, quality management system, cleanroom infrastructure meeting cGMP standards, quality control processes, technical equipment, specialized human resources, and manufacturing operations were examined in detail. The center’s compliance with relevant regulations and international quality standards was officially certified.

With the authorization, GENKOK has taken its long-standing stem cell research to a new stage by adding exosome manufacturing to its activities. The center will also conduct research aimed at developing advanced biotechnological products for use in clinical trials. These efforts are intended to contribute to the development of domestic health biotechnology, strengthen regenerative medicine research, and advance the scientific infrastructure needed for innovative treatments.

- “Official certification of our scientific expertise and manufacturing infrastructure”

Erciyes University Rector Prof. Fatih Altun said the authorization certificate represents an important milestone not only for the university but also for Türkiye’s vision in healthcare.

Saying that the achievement is the result of scientific research conducted over many years, Altun continued:

“This authorization certificate is an official certification of our scientific expertise built up over many years, our meticulously conducted work, and our strong manufacturing infrastructure. Our center is currently the only public institution in our country engaged in stem cell manufacturing. With this new authorization, we have brought stem cell and exosome manufacturing capabilities together under the same roof, taking our capabilities to a much higher level.”

- Advanced biotechnological products to be manufactured in Türkiye

Emphasizing that exosomes are among the therapeutic technologies of the future, Altun said, “Exosomes are a technology of the future that lies at the heart of innovative treatments worldwide and supports tissue repair and cell regeneration. With this authorization, we will now manufacture these advanced biotechnological products to international standards in our own country, develop our domestic health biotechnology capabilities, and lead the way in enabling our patients to access innovative treatments through our own infrastructure.”

Altun said the university’s goal is not merely to produce scientific knowledge but also to shape the treatments of the future, and thanked the academic, administrative, and technical staff who contributed to the achievement.

- Supporting clinical research

GENKOK Director Prof. Serpil Taheri thanked the university administration for its contributions to obtaining the manufacturing authorization and recalled that the center has been engaged in stem cell manufacturing since its establishment.

Taheri said that with the authorization obtained from TITCK, they had begun exosome manufacturing in the public sector for the first time. “With the manufacturing authorization we received from TITCK, we have begun the first and only exosome manufacturing operation in the public sector. Through this manufacturing capacity, we aim to support patients as well as numerous clinical research projects in our country,” Taheri said.

Taheri said they would continue their work on the development and standardization of exosome-based biotechnological products, adding, “Opening the way for research in this field in Türkiye will enable our country to strengthen its position on the international stage, conduct larger-scale research, and provide greater scientific support. Our goal is to become a center that manufactures to international standards and contributes to the development of new treatment options.”