Panacell Biotech Earns ISO 9001 Certification, Strengthening Global Quality Standards for Pulmonary Fibrosis Therapy Development

Panacell Biotech Earns ISO 9001 Certification, Strengthening Global Quality Standards for Pulmonary Fibrosis Therapy Development

Panacell Biotech, a company at the forefront of innovation in advanced regenerative medicine and cell therapy, announced that it has obtained ISO 9001, the internationally recognized quality management system (QMS) certification established by the International Organization for Standardization (ISO).

Panacell Biotech specializes in regenerative medicine and operates both an advanced regenerative medicine institution and its own human cell management and cell processing facilities. Recently, the company successfully demonstrated the reversal of pulmonary fibrosis caused by exposure to humidifier disinfectants, a serious public health issue and a form of intractable lung disease, in preclinical studies. The findings were subsequently published in a prestigious SCI-indexed international journal, providing scientific validation of both the therapeutic efficacy and academic significance of the research.

The acquisition of ISO 9001 certification marks an important milestone, demonstrating that Panacell Biotech's outstanding non-clinical and preclinical research achievements extend beyond laboratory success and are supported by a robust quality management system that complies with internationally recognized standards. The certification formally recognizes the company's ability to consistently maintain high-quality research, manufacturing, and operational processes.

Within the biotechnology and regenerative medicine industries, ISO 9001 certification represents far more than a quality credential. It signifies:

Consistent quality assurance throughout cell therapy manufacturing and cell processing;

Global standardization of processes spanning research and development (R&D), manufacturing, quality control, and operational management; and

Enhanced credibility for future clinical trials, technology licensing, and strategic collaborations with global pharmaceutical companies.

As the safety and efficacy of cell sourcing, processing, and manufacturing are among the most critical factors in the development of therapies for intractable pulmonary fibrosis, this certification is expected to further accelerate Panacell Biotech's commercialization efforts and expansion into the global biotechnology market.

Seungho Choi, Chief Executive Officer of Panacell Biotech, stated:

"Following our successful elucidation of the therapeutic mechanism underlying the treatment of humidifier disinfectant–induced pulmonary fibrosis and the international recognition of our research through publication in a leading scientific journal, the achievement of ISO 9001 certification further validates the global reliability of our research, manufacturing, and quality management systems.

Building upon this rigorous quality framework, we remain fully committed to delivering safe and effective cell therapy solutions to patients suffering from intractable diseases as quickly as possible."