Downstream Processing
Automated Downstream Processing
Comprehensive automation solutions for product purification and final manufacturing in cell and gene therapy
Protect the vitality of your high-value preparations through temperature-controlled processes and high-precision dosing (±1%). Automated final manufacturing for highest patient safety.
Applications
Downstream solutions for cell and gene therapy manufacturing
Aseptic High-Precision Filling with ±1% Accuracy
Filling of cell and gene therapeutics into cryovials is a critical process step requiring highest precision under extreme conditions. Our specialized solutions guarantee sterile, temperature-controlled processing to ensure the vitality of your high-value preparations throughout the entire downstream phase.
- Aseptic High-Precision Filling: Automated filling of cryovials with volumetric accuracy of ±1% to ensure maximum product yield even with smallest batches.
- Integrated Vial Handling: Automatic opening, filling, and gas-tight closing of cryovials within a controlled sterile environment.
- Temperature-Controlled Process Control: Optional sample cooling during the entire filling process to minimize thermal stress on cells.
- 100% In-Process Control (IPC): Integrated weighing stations for real-time fill weight control and automatic documentation of each individual vial.
- Complete Serialization & Coding: Direct printing or labeling of vials with cryo-resistant markings for secure identification in nitrogen environments.
- Full GMP Compliance: The system is consistently designed according to Annex 1 guidelines and provides complete data integrity for batch records.
Secure Secondary Packaging with Robot-Assisted Cartoning
Protection of the finished product until it reaches the patient is of existential importance in cell and gene therapy. Our automated packaging solutions ensure gentle handling of primary packaging materials and complete documentation to guarantee the integrity and traceability of each individual dose.
- Automatic Case Packing & Cartoning: Integration of compact modules for precise erecting of folding cartons and preparation for the filling process.
- Robot-Assisted Cartoning: Gentle insertion of filled containers into cartons or blister nests without vibrations to maintain product quality.
- Leaflet Management: Automated feeding and insertion of package inserts (leaflets) and verification of completeness.
- Final Packaging & Sealing: Closing of cartons including tamper-evident protection for maximum manipulation security.
Let's automate your downstream processes.
I personally advise you on integrated purification and fill-finish solutions for your specific requirements.
