Specially-designed flow distributors
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.
Robust GMP-compliant construction
Constructed from a medical grade polypropylene homopolymer, all product contact surfaces in OPUS® Columns are EMA 410/01 (or Animal Free) and Class VI Compliant.
|Component||Material of construction|
|5 - 30 column tube||ポリプロピレン|
|45R - 80R column tube||70% w/w E-Glass / PP engineered composite structure|
|Inlet and outlet||ポリプロピレン|
|Bed support screens||ポリプロピレン|
|O-rings||Platinum-cured medical grade Silicone|
|Return line||Platinum-cured medical grade Silicone with a strong polyester fiber reinforcement|
Easy cleaning and sanitization
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, an OPUS® 20 Column packed with 6 FF was reliably cleaned of residual phosphate in just 2 CVs.
Winner of multiple awards for design excellence
Reliable multi-cycle performance
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.
Scalable performance consistent across different sizes
Excperiments demonstrate that chromatography separation remains unchanged across different OPUS® Column sizes. This allows for seamless process scale-up and scale-down.
When hIgG was separated from BSA, using OPUS® 1.2, 2.5, 8, and 20 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.
Performance maintained after shipping
OPUS® Columns are shipped in qualified packaging which pass the International Safe Transit Authority’s (ISTA) worst case shipping simulations. Below is a list of simulations included in ISTA test procedure 2B which was performed on OPUS® 45R, 60R and 80R 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.