ROHTO Pharmaceutical Introduces Animal-Origin-Free Stem Cell Culture Medium "R:STEM" — Accelerating Regenerative Medicine R&D with a Century of Pharmaceutical Expertise

Founded in 1899, ROHTO Pharmaceutical Co., Ltd. is a well-established Japanese company initially known for its gastrointestinal medicine and later became widely recognized for its eye drops. Leveraging over a century of pharmaceutical experience, ROHTO is actively expanding into regenerative medicine and advanced cell technologies. In recent years, the company has integrated its expertise in pharmaceutical quality control, manufacturing safety, and clinical research to develop internationally compliant cell therapy solutions.

Design Concept and Features of the Animal-Origin-Free Medium “R:STEM”
"R:STEM" is an animal-origin-free (AOF) culture medium developed by ROHTO to meet the needs of stem cell research and cell therapy development. By excluding animal and human-derived components, it minimizes risks such as xenogeneic immune reactions and viral contamination, helping to maintain cell purity and consistency. Key features include the absence of extracellular vesicles (EVs) and antibiotics to avoid cytotoxicity and metabolic interference, a chemically defined formula for high reproducibility, and a convenient ready-to-use frozen format ensuring batch consistency and ease of use.

Regulatory Compliance and Broad Applicability
With increasingly stringent global regulations in regenerative medicine—especially following Taiwan's Ministry of Health and Welfare's release of the Reference Guidelines for Raw Materials Used in Cell Therapy in late 2023, which emphasize AOF materials for enhanced safety and consistency—R:STEM is well-aligned with these regulatory trends. It holds multiple quality certifications, including Japan’s PMDA-issued Material Conformity Certificate for Regenerative Medical Products and the FIRM certification based on ISO 20399 (Certificate No.: CAM-0001). These credentials make R:STEM a vital resource for research and cell therapy process development, helping to bridge the gap between research and clinical application.

Widely Used in Stem Cell Culture and Exosome Research
R:STEM has been successfully applied to the long-term culture and expansion of adipose-derived stem cells (ADSCs), umbilical cord mesenchymal stem cells (UC-MSCs), and supports studies in skin, bone, and joint regeneration. It is also recognized as a reliable platform for exosome collection and quality analysis, offering stability and safety that are crucial for optimizing cell processing and quality control.

ROHTO and Heng Shun Biotech to Showcase at BioAsia Taiwan 2025
During the 2025 BioAsia Taiwan Exhibition, ROHTO Pharmaceutical will co-exhibit with its Taiwanese distributor,AllisWell Bio Co., ltd., presenting the latest research findings and application cases of R:STEM. Professionals from academia, government, and industry are warmly invited to visit and engage, promoting knowledge exchange and driving forward the industrialization of regenerative medicine.

With its technical expertise and stringent quality control, ROHTO is committed to providing safe, stable, and high-performance cell culture solutions. The company aims to further enhance its technology platforms and strengthen its collaboration networks, positioning itself as a leading brand in mesenchymal stem cell-based regenerative medicine and contributing to its widespread application across the industry.