Drug Product Formulation Development
Formosa Labs has strong formulation development capability to provide our clients proof of concept and early formulation development. Our dedicated R&D team has enabled the development of technology selection methodologies accompanied by our analytical expertise.
Injectable Manufacturing Services
- State-of-the-art injectable facility and team of dedicated experts to provide services from clinical study material to commercial production
- Feasible for cytotoxic, non-cytotoxic and highly potent small molecule and biological products
- Capable of manufacturing pre-filled syringe and vial in liquid and lyophilized drugs products
- Excellent sterility assurance level provided by barrier isolator technology
- An advantage for oxidization sensitive biologics with low hydrogen peroxide (H2O2) residual design
Aseptic Filling Lines Capability & Capacity
| Plant | Filling Line | Type | Filling Quantity | Compounding Volume | Batch Size (qty) | Lyophilizer |
|---|---|---|---|---|---|---|
| V | V1 (Non-cytotoxic) | Liquid | 2 mL~100 mL | 10 L~1000 L | 10,000~250,000 | 30 m2 |
| Lyophilized | 2 mL~100 mL | |||||
| V2 (Non-cytotoxic) | Liquid | 2 mL~20 mL | 1 L~60 L | 100~24,000 | 2.3 m2 | |
| Lyophilized | 2 mL~ 20 mL | |||||
| Pre-filled | 0.5 mL~3 mL | N/A | ||||
| D | D1 | Liquid | 2 mL~100 mL | 1 L~100 L | 1,000~40,000 | 7.2 m2 |
| Lyophilized | 2 mL~ 50 mL |
Secondary Packaging, Labeling and Serialization
- We offer a variety of secondary packaging service including design for packaging a single vial or syringe, and vial labeling under regulatory requirements.
- Instruments Equipped with serialization by TraceLink system for precise tracking and tracing of products from release to patient.
