OPUS® Columns have won multiple awards for Excellence in Industrial Design. learn more
OPUS® flow distributors are designed to maintain uniform flow distribution. The design leverages industry accepted technology, including a radial flow field and anti-jet funnel.
During the development of OPUS® columns, dispersion as a function of column performance was modeled to confirm critical parameters of the flow distributor. The final design was qualified through computational fluid dynamics modeling and applications case studies performed in the OPUS® applications lab.
OPUS® columns deliver the required flexibility for multi-use applications in downstream processing for monoclonal antibodies, recombinant proteins, or vaccines.
The results from a 10-cycle purification of a recombinant protein from E. coli show no substantial difference in run-run consistency and chromatographic performance is maintained over the course of many cycles.
Constructed from a medical grade polypropylene homopolymer, all product contact surfaces in OPUS® columns are EMEA 410/01 (or Animal Free) and Class VI Compliant.*
OPUS® columns are compatible with accepted cleaning and sanitization protocols used in typical downstream processing campaigns for monoclonal antibodies, recombinant proteins, or vaccines.
Using colorimetric measurement of phosphate reduction, a 20 x 20 cm OPUS® column packed with 6 FF was reliably cleaned of residual phosphate in just 2 CVs.
- OPUS® columns contain no significant dead spaces
- OPUS® column design is easily cleanable
Chromatography separation remains unchanged across different OPUS® column IDs as shown in the experiment below. This allows for seamless process scale-up and scale down.
When hIgG was separated from BSA, using OPUS® 1.2 cm, 2.5 cm, 8 cm, and 20 cm columns pre-packed with CaptivA® Protein A resin, with a bed height of 20 cm, plates/m and assymetry specifications were maintained. SDS/PAGE results showed consistent purification over the four column diameters.
OPUS® columns are shipped in qualified packaging which has passed the International Safe Transit Authority’s (ISTA) worst case shipping simulations. Below is an example of ISTA test procedure 2B which was performed on OPUS® 45 cm and 60 cm columns packaged in the qualified crate design. Chromatographic testing was performed in the OPUS® applications lab, and ISTA test procedure 2B was performed at an independent certified test facility.
- High temperature (38° C) and high humidity for 36 hours
- Low temperature (4° C) and low humidity for 36 hours
- Compression testing
- 2 hours of random vibrational testing
- Multiple drop tests