Taipei City, Taiwan and Nivelles, Belgium, March 28, 2024 — BIONET, a leading company in Taiwan’s regenerative medicine field, proudly announces the successful integration of Univercells Technologies’ cutting-edge scale-X™ fixed-bed bioreactor. This collaboration marks a significant stride toward achieving adaptable and scalable production of advanced therapies.
Utilizing the scale-X™ hydro system, BIONET aims to enhance the production of extracellular vesicles produced by Mesenchymal Stem Cells (MSCs) for clinical use. This development is a notable advancement in the mass production of standardized cell and gene therapies.
Distinguished for its expertise in cellular therapy, BIONET possesses core technology and manufacturing capabilities for clinical-grade cellular therapy products. The establishment of the Mesenchymal Stem Cell Repository (MSCR) underscores their commitment to providing cellular applications for over 60 diseases and for offering global exosome Contract Research and Development Manufacturing Organization (CRDMO) services.
“Through continuous innovation, we are committed to developing safer and more effective therapeutic solutions to improve the quality of life of patients,” said Dr. Chris Tsai, Chairman of BIONET. The scale-X hydro bioreactor has demonstrated robust growth of MSCs, reaching optimal cell expansion and viability. The harvested cells produced high yields of Extracellular Vesicles (EVs), after thorough characterization to confirm quality. Tsai points out, “These initial results affirm the potential of the scale-X fixed-bed platform to deliver high-quality exosomes for our clinical and commercial programs.”
Mathias Garny, General Manager of Univercells Technologies adds, “We are proud to partner with BIONET to help optimize the development of the next generation of exosomes. Our scale-X technology is built upon the principles of integration and continuous processing, ensuring a streamlined and cost-effective bioprocessing experience.” Garny emphasizes, “With its unique structured fixed-bed, the scale-X hydro bioreactor provides high density and homogeneous cell growth, delivering high yields of EVs while adhering to stringent quality standards.”
LEVEL Biotechnology Inc., recognized for its preclinical Contract Research Organization (CRO) services and distribution of advanced platforms and reagents in Taiwan, played a pivotal role in introducing the scale-X system. “We are committed to providing customers with the best integrated service solutions,” explained Emerson Chiu, CEO of LEVEL. “Univercells Technologies’ innovative products combined with BIONET’s expertise in the regenerative medicine field appeared to be a great match and we look forward to this collaboration bringing hope to more patients and more breakthroughs to the industry as a whole.”
In a new endeavor, BIONET will expand its Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practices (GMPs) regenerative medical preparation plant this year. This expansion aims to further penetrate overseas markets and mass produce international clinical-grade exosome and cellular preparations. The successful collaboration between BIONET, LEVEL and Univercells Technologies is likely to accelerate innovation in the regenerative medicine field as well as to strengthen Taiwan’s position in the regenerative medicine industry.