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GoBio™ Prod columns are prepacked with WorkBeads™ resins. The columns are specifically designed for purification of biological molecules in GMP production processes, such as vaccines, monoclonal antibodies, and recombinant proteins.
Our pre-packed disposable columns offer more cost-effective solutions than the traditional “pack-in-place” glass or stainless steel columns.
The columns have a sanitary design with minimum dead spaces for effective cleaning. The working pressure rating is 3 to 5 bar and working temperature is 2 °C to 30 °C. Each column is tested for HETP and peak asymmetry. For cGMP grade columns, we also test endotoxin and bioburden levels.
cGMP grade columns are packed inside a class 8 clean room with full testing and documentation under the following quality standards:
- ISO 9001 Quality Management System
- All materials in direct fluid contact path meets USP Class VI, and USP <88> requirements for In Vivo Biological Reactivity
- All columns are packed in a controlled non-classified clean room that meets ISO Class 7 non-viable particle (NVP) standards at rest
- All fluid contact components are free from materials of animal origin or compliant with EMEA 410/01
Bio-Works' GoBio pre-packed chromatography columns provide linear scale-up from process validation to commercial and GMP manufacturing.