CMO
We operate three drug substance manufacturing lines with fermentation capacities of 50L, 200L, and 500–1000L.
Each line has independent HVAC systems for washing, sterilization, fermentation, and purification areas to prevent cross-contamination between products.
We also operate drug product manufacturing lines for vial filling and lyophilization, as well as a pre-filled syringe filling line.
The scope of service
Cell Bank Manufacturing ( MCB, WCB )
Drug Substance (DS) ( 50L, 200L, 1,000L )
Drug Product (DP)
( Liquid vials, Lyophilized vials, Prefilled syringes )
mRNA Manufacturing
| Facility | Configuration & Use | Servicves Provided | |
|---|---|---|---|
| GMP Manufacturing Facility | 50L | 50L fermentation and purification systems |
Cell Bank manufacturing Non-clinical / clinical material production |
| 200L | 50L, 200L fermentation and purification systems | ||
| 1,000L | 50L(x1), 200L(x1), 500L(x2) fermenters and purification systems | ||
| BSL-3 (200L) | 50L, 200L fermentation systems | BSL-3 strain cultivation | |
| mRNA (S) | 5L IVT & LNP | mRNA synthesis and LNP formulation | |
| mRNA (L) | 15L IVT & LNP | ||
| Fill & Finish (Vial) |
5,000 vials/hr including lyophilization (2R & 6R) | Finished vial filling | |
| Fill & Finish (Syringe) | 1ml prefilled syringe | Bulk drug filling | |
fermentation / purification line
GMP-compliant drug product manufacturing ensures process stability and reproducibility throughout drug substance production.
DP line
-Vial products (liquid and lyophilized) are manufactured under an open RABS environment, where filling and lyophilization processes are performed to ensure high-quality finished drug products.
-Syringe and vial products are manufactured through an isolator-based aseptic filling process, enabling the production of 1 mL prefilled syringes (Short & Long) as well as 2R and 6R vials.
Utility
In accordance with GMP requirements, comprehensive utility systems—such as HVAC, pharmaceutical water systems, clean steam, and compressed air—are operated to ensure stable support of pharmaceutical manufacturing processes.
