As parenteral drug products become more specialized and personalized, so too must the aseptic filling lines used to handle and load them into vials or other primary containers. For advanced formulations designed to deliver small molecules, peptides, proteins or nucleic acids, it can be vital to partner with a CDMO that understands how to reliably manufacture and fill these products to the highest quality standards. Evonik is one of the world’s leading CDMOs for the development, cGMP manufacturing and aseptic filling of complex drug products as well as polymeric or lipid-based delivery technologies. Our aseptic filling lines have the versatility to handle virtually any powder, liquid, suspension or combination form to meet your specific clinical and commercial batch requirements.
Aseptic filling performed in ISO 5 (Grade A) isolators for the safe handling of highly potent or other specialized products
Evonik has a series of semi-automated and automated aseptic filling lines located at its facilities in Birmingham, Alabama and Vancouver, Canada. These filling lines feature ISO 5 (Grade A) isolators and are equipped for the efficient aseptic processing and safe handling of synthetic or biologic drug products, controlled substances and flammable solvents. Each filling site can formulate and fill liquids, powders, suspensions and combination forms into vials up to 30 or 50 mL in size. Clinical and commercial scale diafiltration and aseptic lyophilization systems are also available at either site.
An advanced, modular and fully integrated aseptic filling platform for clinical or commercial batch sizes
Evonik has recently qualified a new VarioSys aseptic filling line at its Birmingham facility. The fully automated line is equipped with a versatile, integrated series of modules to support all stages from the entry of bulk material until the quality inspection and release of the filled product. Modules include washing, siliconization, depyrogenation, sterilization, filling, lyophilization, crimp and seal and external vial washing of the finished product. SKAN isolators and GEA lyophilization technology also provide significant aseptic filling versatility, even for highly potent molecules. Automated 100% weight verification also minimizes product loss and optimize levels of quality and safety through improved dosing accuracy. All components and equipment can easily be interchanged to facilitate high-yield manufacturing, or the rapid conversion to a new formulation. For more information on the VarioSys filling line, read this White Paper.
Aseptic filling lines for clinical batches in liquid, suspension, lyophilization and powder forms
We operate a series of aseptic filling systems located in our clean rooms at the Birmingham and Vancouver facilities that are suitable for your clinical batch requirements. The systems can handle the filling of liquid, suspension and powder with lyophilization dosage forms in vial sizes up to 50mL in size. These semi-automated aseptic filing systems can support development, clinical, and commercial scale batch sizes making them ideal for your pre-clinical and early clinical phase requirements with site scalability as your assets achieve clinical milestones to commercial.