OptiPharm Acquires cGMP Facility to Accelerate Xenotransplantation Commercialization

For Clinical Trials and Production of Xenogeneic Skin, Cornea, Pancreatic Islets, and Blood

Biotechnology company OptiPharm has acquired a cGMP (current Good Manufacturing Practice) facility necessary for clinical trials and production of advanced biopharmaceuticals, accelerating the commercialization of its xenotransplantation business.

On October 6, OptiPharm announced that it had acquired the existing cGMP facility of Seedmogen, a company specializing in viral vector and vaccine process development. As Seedmogen expanded and built a new cGMP facility at its Osong site, the existing facility was transferred to OptiPharm. The two companies have previously collaborated on a government-funded project for the development of a hand, foot and mouth disease vaccine.

With this acquisition, OptiPharm will be able to reduce the time and procedures required to build its own facility from scratch, and secure the necessary foundation for entering xenotransplantation organ clinical trials as well as for the production of clinical and commercial samples.

The acquired facility is located in Songjeong-dong, Cheongju, adjacent to OptiPharm's Osong headquarters, and has a total floor area of approximately 544 square meters. The company plans to utilize the facility for clinical trials and production related to its xenotransplantation pipeline, which includes skin, cornea, pancreatic islets, and blood.

Hyunil Kim, CEO of OptiPharm, stated, "This cGMP facility acquisition is a strategic step toward commercializing xenotransplantation organs," adding, "We will rapidly pursue cGMP certification based on the secured infrastructure to accelerate clinical entry."

Currently, OptiPharm is carrying out three government-funded research projects, collaborating with more than 70 researchers from six hospitals and universities in Korea, to study seven xenotransplantation pipelines including cells, tissues, solid organs, and blood. Among these, the xenogeneic skin is being developed as a medical device and is currently in the safety testing phase. The company views the xenogeneic skin as the most likely pipeline to be submitted for clinical trials first.

Regarding the xenogeneic cornea, the company explained that it has secured data that meets the clinical trial conditions specified by the International Xenotransplantation Association (IXA). According to IXA, the requirements are that at least five out of eight non-human primates survive for more than six months, and that at least one survives for more than one year. In addition, OptiPharm announced that it has also obtained cases where non-human primates with transplanted xenogeneic kidneys and hearts have survived for over 200 days.

This content was produced with the assistance of AI translation services.