SUZHOU, China – Dec. 11, 2019 – Re-Stem Biotech (Re-Stem or the Company), a biotechnology firm engaged in the research and development of cell-based therapies and products for various indications, including osteoarthritis, stroke, spinal cord injury and cancer, today announced that it has recently upgraded the cleanroom class of its cell therapy development and manufacturing facility in Suzhou, China, and received good manufacturing practice (GMP) certification from the Suzhou Institute for Drug Control (SZIDC).
On November 28, 2019, the Center for Food and Drug Inspection (CFDI) released a draft proposal [1] of new standards for cleanrooms handling cell therapy products covering both production conditions and management systems to ensure a higher drug quality from bench to bedside. Currently, the standard for such cleanrooms in China is “C+A”, however, the draft proposes this to rise to “B+A” class. The B+A class stipulates less than 3,520 particles of size ≥0.5 μm/m3 both at rest and in operation, which is on par with EU and USA GMP guidelines for cell therapy cleanrooms (ISO5). This class also requires a B level cleanliness for production and operation of cell therapy products, including:
• Production, operation and transfer of the product in partially closed containers;
• Preparation of solutions and culture media that is not sterilized or filtered;
• Packing of virus vector after sterilization and filtration.
This approval of Re-Stem’s upgraded cleanroom certifies compliance with proposed new B+A GMP standards, including manufacturing of biological medicinal/biotechnology products, biological active substances and dosage forms containing biological active substance, and quality control testing and packaging operations.
“This certification ahead of the implementation of the new cleanroom regulations demonstrates the company’s commitment to quality development and manufacturing practices,” commented Benno Jiao, CEO of the Company. “This allows us to move forward in the manufacturing of safe and effective biopharmaceuticals on a commercial scale in China, and also facilitates possible future partnerships with international discovery and development firms, as well as research hospitals and institutional partners.”
Re-Stem currently operates clinics and research and development laboratories in Suzhou, Shenzhen, Beijing, Kunming and Ganzhou.
[1] https://www.cfdi.org.cn/cfdi
About Re-Stem Biotech
Re-Stem Biotech (Re-Stem) is a biotechnology firm engaged in the research and development of cell-based therapies and products. Backed by state of the art GMP facilities and an international team of world-leading scientists, doctors and management team, Re-Stem currently has a robust technology platform including four profitable therapies on the market and eight other therapies and products in the pipeline. Incorporated and headquartered in 2012 in Suzhou, China, Re-Stem is focused on the large and aging population of China. It also operates clinics and research and development laboratories in Shenzhen, Beijing, Kunming and Ganzhou. For more information visit Re-Stem Biotech website: https://www.restembio.com/
Contact
Judyanna Yu
Re-Stem Biotech
judyanna@restembiotech.com