Establishing a cGMP Facility
- Necessity
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- ㆍIn order to manufacture artificial organs for animal substitution utilizing bio-printing, GMP facilities are essential as they can be manufactured in facilities and certified locations with established Good Manufacturing Practices (cGMP) conditions that ensure basic cleanliness, stability, and validity. As a typical example, it is essential to establish a highly reliable GMP facility to produce prototypes such as artificial skin for cosmetics testing.
- ㆍAs there is no cGMP production facility specialized in manufacturing artificial tissues for animal substitution using bio-printing in Korea, we plan to support pharmaceutical and cosmetics companies in the Gyeongbuk region by establishing a cGMP production facility for animal substitution test evaluation, and expand technical services for 3D printing animal substitution test evaluation in the future. In particular, in the process of utilizing artificial organs in the development of cosmetics and pharmaceuticals, time and distance factors can lead to deterioration in the quality of artificial organs and uncertainty in the results of efficacy testing, so we plan to build the facility physically close to companies.
- Basic Plan (Draft)
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- ㆍLocation : Pohang Convergence Technology Industrial District (Pohang Knowledge Industry Center, Units 101~104)
- ㆍConstruction scale : 458.4 ㎡ (approximately 140 pyeong) / ※ Based on space for exclusive use
- ㆍFacility composition : Bio-printing room (printing room), culture room, quarantine room, filling room, aseptic preparation room, self-storage room, clean corridor, record room, etc. that are appropriate for the composition of cGMP facilities
- ㆍFacility purpose : 2 types of artificial organ (artificial skin and artificial lung) production/manufacturing facility
Artificial organ production/production facility using bioprinting
Pohang Knowledge Industry Center 1F
Inside Artificial organ production/production facility using bioprinting
Pohang Knowledge Industry Center 1F
Establishment of Wet-Lab for alternative evaluation
(for corporate support)
- Necessity
-
- ㆍIn order for companies in the front and rear industries related to artificial tissues for animal substitution to complete a series of development processes, such as the production of artificial tissues for animal substitution, trial evaluation and efficacy verification of products utilizing artificial tissues, cGMP and non-GMP facilities are needed in close proximity to cGMP facilities.
- ㆍIt is planned to be utilized as an infrastructure that can be used as a core facility by specialized research institutes (Cell Membrane Protein Research Institute, Green Vaccine Demonstration Center, etc.) and companies in the bio-health field in the Pohang Convergence Technology Industrial District.
- Basic Plan (Draft)
-
- ㆍLocation : Pohang Convergence Technology Industrial District (Pohang Knowledge Industry Center, Units 201, 202, 207 & 208)
- ㆍConstruction scale : 428㎡ (approximately 130 pyeong) ※ Based on space for exclusive use (can be changed if additional space is required)
- ㆍFacility composition
- -Efficacy/Toxicity evaluation room: Test and evaluation of biomaterials utilizing artificial skin and artificial lungs
- -Quality analysis room: Basic research facilities/equipment for test evaluation and quality analysis
- -Sample storage room: Storage of artificial organs and biomaterials for test evaluation, etc.
- ㆍFacility features : Research/enterprise support facility for efficacy evaluation (demonstration) utilizing artificial tissues as a non-GMP facility
Test analysis/performance evaluation facility common use facility
Pohang Knowledge Industry Center 2F
Inside Test analysis/performance evaluation facility common use facility
Pohang Knowledge Industry Center 2F
