AllisWell Bio has introduced R:STEM, an advanced animal origin-free (AOF) cell culture medium developed by Japan’s ROHTO Pharmaceutical. Designed to support cell therapy, regenerative medicine, and biologics development, R:STEM enhances the safety, consistency, and clinical potential of cell culture technologies in Taiwan.

Riding the Wave of Policy Reform to Elevate the Industry

In 2024, Taiwan passed two landmark laws—the Regenerative Medicine Act and the Regenerative Medicinal Product Act—marking a new era of institutionalized and clinically applicable cell and gene therapy. These laws emphasize quality control, traceability of materials, and stricter regulations on human- or animal-derived reagents, requiring viral safety verification and virus removal data to manage risk. They also encourage the use of animal-free ingredients and GMP-compliant raw materials in cell production processes.

R:STEM aligns perfectly with these regulatory trends. Its xeno-free formulation and high batch-to-batch consistency make it an ideal solution for bridging lab-scale research and large-scale clinical manufacturing.

Regulatory links: Regenerative Medicine Act Regenerative Medicinal Product Act
CDE Official Notice: No. 1141663847

R:STEM: Redefining the Standard for Stem Cell Culture

R:STEM is a next-generation, animal origin-free medium developed by ROHTO Pharmaceutical with a focus on clinical-grade regenerative medicine. It is specifically optimized for the long-term, stable expansion of human mesenchymal stem cells (hMSCs). Key features include:

• AOF formulation: Free of animal and human-derived components, minimizing risks of immune rejection and viral contamination.
   
• EV-free: Excludes extracellular vesicles (EVs), helping maintain consistent cell phenotypes.
   
• Antibiotic-free: Avoids potential cytotoxic effects, promoting healthy cell growth.
   
• Chemically defined composition: Transparent formulation with high batch reproducibility reduces quality control burdens.
   
• Ready-to-use format: Usable immediately after thawing with no need for additives, simplifying workflows and QC.
   
• Certified for clinical use: Manufactured under strict standards, R:STEM has received product material approval from Japan's PMDA (Product Code: EM1-500) and certification under FIRM standards (ISO 20399, Certificate No. CAM-0001), supporting smooth transition from R&D to GMP manufacturing.
   

Versatile Applications Driving Clinical and Industrial Growth

R:STEM supports a wide range of use cases, including:

• Regenerative medicine research: Enables robust expansion of stem cells for applications such as neural regeneration, skin repair, and orthopedic reconstruction.
   
• Process development and optimization: Ensures long-term stability of stem cells like ADSCs and UC-MSCs, supporting the creation of standardized protocols.
   
• Cell therapy manufacturing: Provides a traceable, scalable, and regulatory-compliant AOF platform for clinical-grade cell therapy products.
   
• Biologics and EV production: Ideal for producing exosomes, bioactive proteins, and cell-secreted factors for downstream therapeutic applications.
   

More product details: R:STEM

AllisWell Bio Builds a Localized Ecosystem for Real-World Implementation

With a full suite of product onboarding and technical support services, AllisWell Bio helps research institutions, biotech firms, and clinical labs integrate R:STEM into their processes—from early evaluation to scale-up and manufacturing. The company remains committed to introducing cutting-edge, regulation-ready solutions to help Taiwan’s regenerative medicine industry achieve global standards.