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OPUS® 5 - 80R Pre-packed Columns
Technology

Winner of multiple awards for Excellence in Industrial Design, OPUS® Columns lead the industry with unique design features and proven performance.

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Unique Design Features

OPUS® Column technology
OPUS® Column technology

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.  

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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 Polypropylene
45R - 80R column tube 70% w/w E-Glass / PP engineered composite structure
Flow distributors Polypropylene
Inlet and outlet Polypropylene
Bed support screens Polypropylene
O-rings Platinum-cured medical grade Silicone
Return line Platinum-cured medical grade Silicone with a strong polyester fiber reinforcement

 

Phosphate reduction

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.  

  • OPUS® Columns contain no significant dead spaces
  • OPUS® Column design is easily cleanable

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tested and proven performance

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. 

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OPUS® Column technology

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.

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OPUS® Column technology

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. 

  • 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
  • Columns were packed with cross-linked 6% Agarose resin, ~90 micron particle size

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