The Korean regenerative biopharmaceutical firm CGBIO announced the opening of its cGMP manufacturing facility in Hyangnm, Gyeonggi-do, paving the way for global expansion.
After an 8-month construction period (from September 10, 2018 to May 20, 2019), CGBIO’s newly constructed plant called ‘S-CAMPUS’ (S = Smart) is an ultramodern cGMP facility with an appropriate design to meet requirements of advanced countries (the U.S., Japan) and to facilitate operations under a 24-hour unmanned robot production.
The new facility’s production lines include aesthetic & plastic fillers, anti-adhesives, stents, wound dressings (EasyDerm/EasyDerm Beauty), synthetic bone implants, and human tissue processing banks.
With a total floor area of 46,892 m2 (around 14,209 pyung), the new facility has a two-story building. By the nature of materials, the first floor is intended for commercial production of fillers and anti-adhesives, with the second floor intended for synthetic bones, stents, and human tissue processing banks.
The GMP cleanroom facility is installed with a digital thermo-hygrometer, a digital differential pressure gauge, and a digital particle counter. It can control aseptic conditions. In addition, a variety of data can be monitored in real time. All relevant data are backed up. Any manipulation is unavailable. The quality control and manufacturing process can be easily monitored by visual inspection.
As for the video surveillance system, the installation of an intelligent closed-circuit system (CCTV) allows for personnel to focus and auto-record the internal movement, thus preventing any fire or accident. The facility production line, which can be operated for 24 hours, has sufficient extra components such as freezer, compressor, and water treatment system.
The new facility is characterized by the concept of ‘A manufacturing plant that does not look like a manufacturing plant’. To capture CGBIO brand image, a front layout approach was adopted when selecting the plant location instead of crossing the middle of the area as seen in conventional plants. In addition, the manufacturing plant is named ‘S-CAMPUS’ since it is a complex space that can be used for entry and training of employees and customers as well as for manufacturing.
To make windows suitable for cGMP environment where the space for windows is quite limited, available space in corridor and office room is fully utilized in the viewpoint of design using random placement of windows.
By taking advantage of the high performance of polycarbonate as exterior material of the cCMP plant, polycarbonate sheets were used to create various architectural expressions (transparency and opacity), depending on the angle of natural light and illumination at night. Polycarbonate is an appropriate synthetic material that can not only break away the crude image of a plant, but also match the novel brand image. As such, the use of ‘double skin’ material can help reflect the design with resulting energy efficiency benefits.
All finishes with natural property were used without a second processing. Like a mono-tone interior, all spaces were unified using one color to provide a concise and sophisticated impression as a strategy to utilize the area-restricted space more effectively by focusing on the vertical space rather than the horizontal space.
Considering the smart-office concept that pursues minimalism in a simple manner, the office room design has been upgraded to help increase concentration. All bathrooms in the plant had indirect lights as shown in hotel bathrooms. Rooms for rest and shower for night-shift workers are also provided.
“When initiating design of the new facility, we focused mainly on business objective & product features, slogan/philosophy, keywords, directionality, sustained potential, minimalism-based design, environment-friendly materials, and placement considering the environment,” said CGBIO officials. “To capture interest in people, research, and history, efforts were made to instill trust indirectly but clearly rather than directly delivery to the people who encounter the building.”
The CGBIO S-Campus will be inspected for approval of the KGMP accreditation on October 22, 2019 and further screened for CE certification at the end of November of 2019.
“To date, we have reached several agreements with foreign partners, namely, a KRW 40.0 billion contract with Indian and Brazilian pharmaceutical companies for supply of NOVOSIS, an export of Giselleligne HA filler to China, and a KRW 600 billion with Nippon Zoki for supply of NOVOSIS Putty. Thus, CGBIO Globalia Project has finally shown tangible results,” said CGBIO CEO Hyun Seung Yu.
“CGBIO had a plan to contemplate its production facility expansion to meet global demand in medical device sector five years ago. It is sincerely hoped that the opening of the cGMP S-campus will be a significant opportunity to further expedite the CGBIO Globalia Project in the global arena, including the U.S. and Japan.”
