in Europe

in Europe

Custom development and automated aseptic production of liquid and lyophilized drug product

About the plant

Custom development and automated aseptic production of liquid and lyophilized drug product

Our new GMP-compliant state-of-the-art facility, opened in Q1 2023, is dedicated to the development, sterile production, testing and release of injectable drug products. This facility has two fully automated filling lines and will allow CARBOGEN AMCIS to supply customers with clinical batches for phase III clinical trials and small-scale for commercial. The facility has the capability to handle complex formulations, including a large range of APIs from biologics to highly potent compounds.

Activities

• Two production lines offering liquid and lyophilized sterile injectable drug product
• Aseptic formulation of up to 400 litres
• Handling of Highly Potent products with OEB 4+ category
• Drug product formulation development and analytical method development, transfer and validation
• State of the art chemistry laboratories to support in-process and finished product testing
• Microbiological platform to perform bioburden, sterility and endotoxin testing
• Stability chambers to support ICH stability studies

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Certifications

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Activity

• manufacturing

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Features

• Uses:
• Toxicity (OEB classification):
• DEA: N/A
• BSL:
• Therapeutic areas: N/A
• Markets:

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Batch Size / Reactor

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Services