Pamisel Obtains License for Advanced Biopharmaceutical Manufacturing

[Asia Economy Reporter Hyungsoo Park] Pamicell? announced on the 4th that it has obtained a license for manufacturing advanced biopharmaceuticals from the Korea Ministry of Food and Drug Safety. Through this, it will actively promote the advanced biopharmaceutical contract development and manufacturing organization (CDMO) business.

According to the "Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals," which has been enforced since August last year, only companies that meet the facilities and standards prescribed by the Presidential Decree and have obtained approval from the MFDS Commissioner can handle cell therapy products and gene therapy products.

A company official said, "By obtaining the license, we have established a foundation to accelerate not only stem cell therapy research and production but also the advanced biopharmaceutical CDMO business." He added, "We possess leading stem cell therapy development technology and MFDS-certified GMP production facilities," and "We expect to expand partnerships with bio companies facing difficulties due to lack of facilities and experience."

CDMO is a business combining contract manufacturing organization (CMO) and contract development organization (CDO), representing a collaborative structure with partner companies beyond the concept of producing clinical trial and commercial drugs on consignment. It refers to a service that supports the entire new drug development process from cell line development to clinical trials and marketing approval.

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