IFEZ Journal

Celltrion Prepares for Its Move into the Global Biotechnology Research Center

Celltrion has completed the trial run of its Global Biotechnology Research Center, built in Songdo, and started validations to check the main functions of the center. This large-scale facility complex can be used to simultaneously conduct R&D, process development, and clinical trials. After a construction period of 26 months, the building obtained usage permission in January this year.

The Global Biotechnology Research Center has an area of 10,033 ㎡ across one basement floor and six floors above ground. All research activities for clinical entry are possible at this center equipped with state-of-the-art research facilities, such as a pilot lab capable of non-clinical DS production and charging actual costs for non-clinical DP production. Full-fledged occupancy is planned to begin in April, and the concentration of human resources for bio and chemical medicine research will contribute to expanding research fields into new drug modalities and drug-delivery technologies.

Establishment Date February 27, 1991

Type of Business Manufacture of medicinal chemicals and antibiotics

Product/Business Research, development, and manufacturing of protein drugs

Address 23 Academy-ro, Yeonsu-gu, Incheon

Igus Korea Unveils ReBel, the 6-Axis Articulated Robot Arm 

Igus Korea participated in the Smart Factory Automation Industry Exhibition 2023, which opened at COEX, Seoul, 

on March 8, and unveiled ReBel, its 6-axis robot arm, for the first time in Korea.

All moving components of ReBel are made of igus Korea’s unique engineering plastic material. As all parts are made of plastic, this robot arm boasts an ultra-light weight of 8.2 kg. 

As a representative product of the LCA line, it is characterized by strong cost performance.

In addition, the sensors built into ReBel enable a simple cloud connection and real-time monitoring right out of the box and without additional software. The plug-and-play version, including a controller and power supply, costs only EUR 4,970, which is expected to contribute significantly to lowering the entry barrier to automation in Korea.

Establishment Date January 1, 2001

Type of Business  Wholesale of machinery and equipment

Product/Business  Cable, bearings (energy chain) wholesale/retail, and manufacturing

Address 42 Venture-ro 12beon-gil, Yeonsu-gu, Incheon

Samsung Bioepis Obtains a Positive Opinion for the Approval of a Rare Disease Treatment in Europe

Samsung Bioepis has obtained a positive opinion for the approval of the sale of its biosimilar “EpylusTM (project name SB12, trade name eculizumab)” to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which is responsible for providing scientific advice and making recommendations on the authorization of medicines in the European Union. EpylusTM is a biosimilar of Soliris. Soliris is an ultra-expensive biopharmaceutical developed by Alexion Pharmaceuticals in the United States, used to treat rare and life-threatening diseases, such as paroxysmal nocturnal hemoglobinuria (PNH). Its annual treatment cost is in the hundreds of millions of won (or tens of thousands of dollars), 

and its global annual sales reached USD 3.762 billion last year. EpylusTM is the first product developed by Samsung Bioepis in the field of hematology, and it is expected to obtain official sales approval through the final review process of the European Commission (EC), which usually takes about two to three months.

Establishment Date February 28, 2012

Type of Business  Research and experimental development on medical sciences and pharmacy 

Product/Business  Research and development, manufacturing, wholesale, and retail of medical and pharmaceutical products 

Address 76 Songdogyoyuk-ro, Yeonsu-gu, Incheon

i-SENS Opens the Localization of a Continuous Blood-Glucose Monitoring System

On February 28, i-SENS applied for product approval of CareSense Air, a continuous glucose monitor (CGM), to the Ministry of Food and Drug Safety. A CGM is a real-time device to measure blood sugar through a sensor inserted into the skin. The market for this device is rapidly growing because of its convenience compared to existing products used to measure blood sugar by piercing the fingertip with a needle. Currently, all products on the domestic market are imported. i-SENS‘s CareSense Air is the first successful development case in Korea.

CareSense Air complied with the provisional standards in the clinical trial completed in the third quarter of last year and obtained a high accuracy of 9.8% in the subject-based MARD value. This product is set to receive approval in the third quarter of 2023 in order to launch in the domestic market in the fourth quarter. i-SENS has also applied for authorization to European CE for overseas exports, with plans for completion by the first half of next year.

Establishment Date May 4, 2000

Type of Business  Manufacture of electro-diagnostic and electro-therapeutic apparatuses

Product/Business  Biosensor for the medical environment industry (blood-glucose meter), manufacturing of measuring equipment, wholesale/retail, and development

Address 12 Harmony-ro 275beon-gil, Yeonsu-gu, Incheon