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We have set an example of quality control by receiving an approval on KGMP facilities from MFDS, and produce high-quality biopharmaceuticals with standard hi-tech production facilities.

CDMO

With many years of manufacturing technique of cell therapy, qualified research experts provide CDMO such as manufacturing investigational medicinal products, conducting quality tests, and so on.
*CDMO(Contract Development and Manufacturing Organization)
*KGMP(Korea Good Manufacturing Practice)
*MFDS(The Ministry of Food and Drug Safety, KFDA)

01

Drug Product

Cell Therapy Product (autologus, allogenic, xenogenic) Gene / Stem Cell Therapy Product Formulation Development

02

Drug Substance

Blood or Cell separation Cell stock Manufacturing Cell media

03

Quality Control

In vitro viral test (In vitro) Mycoplasma test Sterility test

04

Consulting

Regulatory CMC Authoring Support Manufacturing Consulting Services Dedicated Project Management.

Plant

Area Total 1,913㎡: 1F 223㎡ / 2F 1,690㎡ 6 Manufacturing Suite: Operation of 100% air supply/exhaust system
Service Advanced facility and sophisticated equipment Highly trained staff and dedicated project management Preparation of documents according to KGMP guidelines State-of-the-art Facility