Zencore's drug product R&D and manufacturing team has received rigorous professional training in aseptic fill-finish and has more than 10 years of industry experience. It has established complete SOPs, technical standard documents and batch production records for drug product filling, and operates two drug product lines with all filling lines running to GMP standards.
Applicable to 2R, 6R, 10R, 20R and 50R liquid and lyophilized drug products; to date completedMultiple projectsdrug product filling.
meet 1 mL slim prefilled syringes, 2.25 mL prefilled syringesand other specification requirements.
Zencore BiologicsAll filling lines operate to GMP standards, undertaking various drug product filling services to meet client needs to the greatest extent.
The drug product lines comply withManufacturing standards of multiple developed countries and China, supporting filings and supply across multiple global regions.
Short waiting time from drug substance release to the start of filling, enablingSeamless connection, maximizing compression of the production cycle.
Linjia Base liquid filling capacity reaches 24,000 vials/hour, lyophilization capacity reaches 58,000 vials/batch。
| Vial formats | Filling capacity (vials/hour) |
|---|---|
| 2R | 24,000 |
| 6R | 23,580 |
| 10R | 21,600 |
| 20R | 18,000 |
| Specifications | Filling capacity (units/hour) |
|---|---|
| 0.5mL / 1mL | 21,300 |
| 1mL | 17,100 |
| 2mL | 16,200 |
| 3mL | 15,350 |
| Vial formats | Filling capacity (vials/batch) |
|---|---|
| 2R / 4R | 58,850 |
| 6R / 8R | 30,490 |
| 10R / 15R | 25,740 |
| 20R / 25R / 30R | 16,590 |
* 50R liquid and lyophilized drug products also fall within the applicable specification range of the aseptic filling and lyophilization line.
GMP-compliant liquid, lyophilized and prefilled syringe filling lines that accelerate the last mile to product launch.
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