Fill/Finish
Cytovance® will perform aseptic vial filling and finishing following purification of the bulk substance. All processing is done with appropriate supporting documentation, in preparation for final testing, labeling, and distribution. Fill/finish is available as a stand alone service.
Capabilities include:
- Segregated Formulation and Aseptic Filling Suite
- Class 1000 rooms with local class 100 for aseptic operations
- Manual and Semi-automated processing
- Validated Processes
- Compliant with European requirements for the step down from ISO7 to ISO 6 to ISO 5
- Qualified Person (QP) available for release of product for European markets.
- Co-ordinated labeling and shipping to clinical sites