Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. is a Development Stage Biomedicine Firm engaged in the Development of effective Treatments for degenerative and cancerous Diseases.
Cellular Biomedicine Group (NASDAQ: CBMG) is a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases utilizing proprietary cell therapy technologies. CBMG is the result of the acquisition, transfer, commercialization and advancement of thirty years of research and human treatment experience in cellular medicine. CBMG’s cellular research and development comes from collaboration among scientists and doctors from the US, Europe and China.
The CBMG corporate business development strategy has two approaches: partnering programs at the stage of early to mid clinical development (i.e.: Knee Osteoarthritis, Cartilage Damage, Asthma), and licensing other applications after seeing them through the proof of concept stage.
CELL PRODUCTS PORTFOLIO
Our current treatment focal points are cancer and other degenerative diseases such as KOA, Asthma, Chronic Obstructive Pulmonary Disease (COPD) and Cartilage Damage (CD).
- > Robust product pipelines addressing multiple large market opportunities
- > Two products currently in clinical trials
- > Highly experienced executive and scientific team
- > GMP-certified facilities in the PRC designed to international, U.S. FDA standards, and Chinese regulatory bodies’ standards
- > The first cellular medicine company in China accredited with IS0 (International Standards Organization) 9001:2008 certification by internationally recognized quality management system SGS
Cellular Biomedicine Group brings together the world’s latest technology with industry-leading scientists and professors to research and develop safe treatments for those with serious conditions and diseases.
CBMG is proud to have a share in an emerging field that has great potential for a significant positive impact on society. The company’s directors, scientists, doctors and employees share a sense of responsibility that ensures that the company maintains stringent international safety and quality control standards and focus on the patients and caregivers who will benefit the most from the application of breakthroughs in regenerative medicine.
CBMG is focused on developing and marketing safe and effective regenerative and cell-based therapies based on our cellular platforms, to treat serious injury and degenerative diseases including cancers, orthopedic diseases including osteoarthritis and tissue damage, various inflammatory diseases and metabolic diseases. CBMG has developed proprietary practical knowledge in the use of cell-based therapeutics that it believes could be used to help a great number of people suffering from cancer and serious chronic diseases. CBMG has two therapies undergoing clinical studies in China: stem cell based therapies to treat knee osteoarthritis (“KOA”) and an immune cell therapy to treat liver cancer (“HCC”). We have initiated preclinical studies in Asthma, and Chronic Obstructive Pulmonary Disease (“COPD”) and clinical research studies in cartilage defect stem cell therapy.
The unique lines of adult adipose-derived stem cells and the immune cell therapies enable CBMG to create multiple cell formulations in treating specific medical conditions and diseases, as well as applying single cell types in a specific treatment protocol.
Management believes that its adult adipose-derived line will become commercially viable and market-ready within three to four years, and will continue to grow the budding immune cell technical service revenue. CBMG’s facilities are certified to meet the international standards NSF/ANSI 49, ISO-14644 (or equivalent), ANSI/NCSL Z-540-1 and 10CFR21, as well as Chinese CFDA standards CNAS L0221. In addition to standard protocols, CBMG uses proprietary processes and procedures for manufacturing our cell lines, comprised of:
- – Banking processes that ensure cell preservation and viability;
- – DNA identification for stem cell origin chain of custody; and
- – Bio-safety testing at independently certified laboratories
CBMG has two facilities in Shanghai and Wuxi, China that meet international standards and have been certified by Chinese State Food and Drug Administration (SFDA) authorized accreditation agencies.
• One of the few cell therapy companies in China with facilities certified by internationally recognized ISO accreditation institution SGS
• 20,000 sq. ft. of laboratory & production area
• 6 independent production lines
• Capacity for over 5,000 patients for autologous cell therapies per year
• Two cell banks located in different cities to mitigate risks
US ISO-9001 Certification
The CBMG Shanghai cleanroom facility undergoes a top-to-bottom yearly calibration and validation from ENV Services, Inc., an ISO-accredited, US-based testing and certification company, and has received and maintained an ISO-14644 cleanroom certification. Additionally, CBMG facilities have been certified to meet the ISO-9001 Quality Management standard by SGS Group, and accredited by the American National Bureau of Accreditation (ANBA). These GMP facilities make CBMG the only company in China with facilities that have been certified by US- and European-based, FDA authorized ISO accreditation institutions.
CBMG has a manufacturing and technology team with more than 30 years of relevant experience in China, England, and the USA. All of these factors make CBMG a high quality cell products manufacturer in China.
In total, CBMG facilities have over 20,000 sq. ft. of cleanroom space with the capacity for eight independent cell production lines and a manufacturing capability for over 5,000 patients for autologous cell therapies per year. In addition, CBMG has two cell banks located in Shanghai and Wuxi facilities with a storage capacity to host more than 200,000 individual cell sources. There is also a 400 sq. ft. SFDA-standard products quality control center and an 800 sq. ft. laboratory with state of the art equipment. The CBMG cell banking services include collection, processing and storage of cells from patients. This enables healthy individuals to donate and store their stem cells for future personal therapeutic use.
R&D and Manufacturing Facility