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TCI's GMP
Three advantages of TCI’s GMP
1) More than 20 years of FDA Approved, GMP manufacturing experience
2) Our experiences of many reagents allows us to handle a wide variety of compounds
We can propose process development for scale-up
We can research and develop to meet your target timelines and price.
3) Our experts will proactively discuss your project with you.
TCI's GMP Service Movie
GMP corresponding range
From research and discovery to ingredients of clinical trial for human
| Discovery | Select candidates | Preclinical | Clinical Trial for Human | Approved and Marketed | New Drugs | Expired Patent | |||
|---|---|---|---|---|---|---|---|---|---|
| P1 | P2a | P2b | P3 | ||||||
| TCI’s Availability | |||||||||
We can comply with your requests from research and discovery to synthesis of candidate compounds and scale-up of ingredients for pre-clinical development and clinical trials.
GMP facility
GMP Facility (Opened in 2017), GMP Kilolab (Opened in 2016)
Exclusive manufacturing facility for custom synthesis of ingredients for clinical trials
| Size | 1,034 m2 (height 25 m) |
| Floor levels | 4 |
| Bay series | 2 ＋ (＋1 more in the future) |
| Reactors | 200 L × 2 (GL) 500L × 1 (GL) 800L × 1 (GL) |
| Crystallization Apparatus | 500 L × 1 (SUS) 1,000L × 1 (GL) |
| Corresponding Temperature | -15～120℃ (Cold・Hot Water, Brine, Steam) |
| Centrifuge | 2 (Teflon・SUS) |
| Conical Dryer | 2 (GL) |
| Purification Water Apparatus | Production Capacity 800 L/h |
GMP Kilolab (Operation has started in October, 2016)
- Clean Room (Class 100k) 2 rooms
- Draft Chambers in each room
- Multi Kilolab Unit 25L 1 unit introduced
- Air Shower Apparatus
Exclusive manufacturing facility for pharmaceutical ingredient
- Clean room of "class 100,000" - Booth of "class 100,000" - Repacking room
