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Regenerative Medicine

Facility
EASYWELL BIOMEDICALS's R&D facility houses the Regenerative Medicine Center. This development and manufacturing facility has ample capacity to house the company's growing operations. In addition to our internal projects, we also have the capacity to host collaborative projects ranging from concept confirmation to process/product development.

Our Class 10,000 gown-in/gown-out cleanrooms are equipped with HVAC systems for controlled air flow and room pressure, and areas for material pass-through. The facility also contains cell and tissue cryogenic storage tanks with controlled access, live facilities and equipment monitoring systems with automated alarm call-out, and emergency standby generators, to ensure the highest level of quality control and risk mitigation for product storage. Additionally, our facility has QC and analytical units, as well as product and process development units.

 
Platform Technologies
Cryopreservation Media
Our unique cryopreservation technology and preservation media allow maintenance of a variety of cell types and tissue materials at freezing-temperature, and facilitate maximum viable cell counts upon thawing. Our proprietary DMSO-free cryopreservation media have been developed for therapeutic cell products for human use.
 
Cell Delivery Systems
Successful cell therapy involves multiple critical operations. At bedside administration, the cells to be prepared and delivered to the targeted sites must be viable and healthy for varying periods of time. Our proprietary cell delivery technology, along with a variety of specially designed vehicles, can provide the most effective and reliable cell delivery system.
 
Quality by Design for Scale-up
Our experienced R&D and production teams are capable of designing quality components of target cell-based therapeutic products and providing insights throughout the development and scale-up processes of the products. When issues regarding quality arise, our quality system facilitates efficient analysis of the issue for immediate identification and resolution of the problem.

 
Products
Our regenerative medicine sector focuses on harnessing the remarkable capacity of fetal cells. It is well known that fetal skin wounds in early gestation undergo complete regeneration and healing, a capability that is lost after birth. Many studies indicate that there are fundamental differences between fetal and adult skin cells; hence these differences could be the key to efficient tissue repairmen in fetal wounds.

Clinical observations have further shown that wound dressing products comprising of fetal fibroblasts provide significant clinical benefits in adult wound healing. Patients who received this treatment experienced pain relief, reduction of edema, elimination of fibrin production, reduced scarring, expedited healing, and better functional recovery when compared to patients who received the standard treatment.

Our leading regenerative medicine product, TWB-103, is a therapeutic cell product for wound care. It has been designed to provide ease of storage, transportation, and bedside use in a cost-effective manner for the user.

 
TWB-103
TWB-103, the leading cell-based product from EASYWELL BIOMEDICALS, is a two-component therapeutic product consisting of living allogenic dermal fibroblasts and a proprietary carrier. TWB-103 can be stored for up to six months before clinical application. The cell line is of fetal origin, exclusively acquired from our collaborator in Switzerland. TWB-103 regenerates functional skin tissue by modulating and improving secondary intention wound healing. Product effectiveness, safety, and quality have been extensively validated through non-clinical in vivo and in vitro studies. Additionally, our experts have more than 15 years of clinical knowledge of TWB-103 and other cell lines. Our experience enhances the safety and efficacy for the development of these therapeutic products.

EASYWELL BIOMEDICALS will be seeking IND application for TWB-103 in several countries, including the USA and Japan. The product’s first indication will be for managing surgical and donor site wounds in adults during autografting procedures.