ChabioLab Obtains Manufacturing License for Advanced Biopharmaceuticals

[Asia Economy Reporter Cho Hyun-ui] Cha Biotech announced on the 14th that its subsidiary Cha Biolab has received a manufacturing license for advanced biopharmaceuticals from the Ministry of Food and Drug Safety.

Since the enforcement of the "Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals" (Advanced Regenerative Bio Act) in August this year, Cha Biolab is the first company to obtain a manufacturing license for advanced biopharmaceuticals.

According to the Advanced Regenerative Bio Act, only places licensed by the government as management operators can collect and process human or animal stem cells, hematopoietic stem cells, somatic cells, immune cells, and others.

To receive a manufacturing license for advanced biopharmaceuticals, requirements such as equipment and instruments necessary for pharmaceutical manufacturing and quality control, facilities and personnel for safe storage must be met.

Cha Biolab plans to additionally acquire management operator licenses for human cells required for drug pipeline development and contract development and manufacturing organization (CDMO) business, as well as cell processing facility licenses for clinical research.

Kim Kyung-eun, CEO of Cha Biolab, stated, “We will play an important role not only in stem cell and immune cell therapeutic research and development but also in Cha Biotech’s cGMP-based commercial production, productization, and global CDMO business.”