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OPUS® Large-Scale Chromatography Columns
OPUS® large-scale pre-packed columns deliver proven performance from late-stage development through GMP manufacturing. By eliminating in-house packing and supporting seamless scale-up from process development, OPUS columns help reduce risk, accelerate manufacturing timelines, and improve facility efficiency for modern biopharmaceutical processes.
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Improved operational efficiency
Scalable, flexible platform
Why choose OPUS large-scale columns for GMP manufacturing?
OPUS columns are designed to improve operational efficiency, reduce packing risk, and scale seamlessly from process validation to commercial manufacturing. Select from the broadest portfolio of pre-packed, GMP-ready column sizes, with internal diameters from 2.5 cm up to 80 cm. OPUS columns enhance facility efficiency by eliminating the need for column packing equipment, space, and resources, so scientists and operators can use valuable cleanroom space for higher-value projects.
Drive operational efficiency with pre-packed large-scale columns
Faster turnaround, fewer process steps
Self packed columns add significant time and complexity to downstream operations, often more than teams realize. A typical self packing workflow requires 100 hours and 22 process steps, creating hurdles to productivity.
OPUS pre packed chromatography columns reduce that burden by more than 50%, so you can reclaim days on every chromatography cycle. In contrast to self-packed columns, a typical process using OPUS columns for a manufacturing-scale operation consists of just 10 steps, totaling approximately 40 hours.
Improved process economics and labor efficiency
Using OPUS pre-packed chromatography columns for clinical and commercial manufacturing processes also yields significant cost and labor savings. A case study conducted by KBI Biopharma concluded that the use of OPUS pre-packed columns saved 72 person-hours per column at a large scale, freeing up their teams to focus on other activities.
”In addition to providing a dependably valid, scalable column ecosystem, implementation of the OPUS line allowed considerable benefits throughout the manufacturing campaign for this molecule. A pre-packed column allows the facility to forgo packing activities and frequently bottlenecking documentation (packing protocols, IQ/OQ, document review) in lieu of a simpler asset induction process.”
In another example, over 65% cost savings and up to 80% labor savings were achieved when using OPUS Columns compared to self-packed columns.* These savings were in part due to the elimination of up-front capital expense, reduced labor requirements, reduction in clean-in-place (CIP) procedures, and other operational efficiencies.
*Purchase of OPUS 60R pre-packed column compared to the purchase or a new, 60cm Diameter column and automated self-packing equipment. Data presented is an estimate and subject to change.
Driving efficiency by supporting continuous bioprocessing
The biopharmaceutical industry continues to move from traditional batch processes toward continuous biomanufacturing, resulting in decreased capital and operating costs, improved productivity, decreased facility size, and improved consistency.
In a published case study, collaborators completed a successful pilot scale demonstration of an end-to-end, continuous biomanufacturing process using OPUS large-scale columns. OPUS pre packed columns operated in a fully closed configuration for 48 days, eliminating over 50% of traditional process steps. See how this successful proof-of-concept represents an important step toward the realization of a commercial integrated and continuous biomanufacturing process.
Reduce risk with OPUS large-scale columns
Expertly packed and validated
Column packing is often described as both an art and a science, requiring years of specialized expertise. However, relying on internal packing expertise adds complexity and operational risk to your workflows. Packing failures disrupt schedules, risk product loss, and cause costly delays.
Reduce chromatography risk in your operations with expertly packed OPUS large-scale chromatography columns. By transferring column packing risk to our team of experts, you can stay focused on what matters most: purifying therapeutic target molecules with confidence.
Proven performance you can rely on
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.
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.
OPUS Columns are compatible with accepted cleaning and sanitization protocols used in typical downstream processing campaigns for monoclonal antibodies, viral vectors, nucleic acids, or recombinant proteins.
Using colorimetric measurement of phosphate reduction, an OPUS 20 Column packed with 6 FF was reliably cleaned of residual phosphate in just 2 CVs.
Scalable, flexible large-scale chromatography columns
Built to scale with your process
To help scientists easily scale from process development to commercial manufacturing volumes, we offer an extensive range of OPUS pre-packed chromatography columns that can be easily configured to your specifications. GMP-ready OPUS columns will scale up with your process, from 10-30 cm columns that support 20-500 L bioreactors to 36R, 45R, 60R, and 80R columns designed to meet the requirements of larger 1000 L and 2000 L single-use bioreactors.
Simply select the resin and bed height, and we will pack, qualify and ship the column to your facility quickly.
- Easily configured for bed height, resin, and application
- Seamless scale-up from smaller OPUS Columns
- Complete documentation package for GMP use
- Significant time and cost savings compared to conventional column technology
- Consistent materials of construction
- Class VI, EMA 410/01 compliant materials
- ISO documentation (CoA, RSF)
- Individual column release testing
Flexibility to pack virtually any user-specified resin
Repligen packs over 300 commercially available and custom chromatography resins. Typical resins are 30 to 120 µm particle size on base bead matrices composed of agarose, methacrylate, cellulose, or polystyrene.
CHT™ Resin Pre-packed in OPUS Columns
Repligen offers the flexibility to pack challenging resins, including ceramic hydroxyapatite (CHT™). CHT™ resin offers unique selectivity during the purification of mAbs and recombinant proteins. The following OPUS column configurations can be pre-packed with CHT™ resin and shipped worldwide with excellent performance:
- Internal diameters from 5−60 cm
- Bed heights from 5−30 cm
View the full performance data
CHT™ is a trademark of Bio-Rad Laboratories, Inc.
Performance maintained after shipping
Average plate count and asymmetry variance post-shipping was within 8% and 3%, respectively, of the pre-shipping value. Absolute values were within the specification window.
Innovative resin recovery port
With an innovative side port that allows for easy resin unpacking, OPUS columns with an “R” designation—including 36R, 45R, 60R, and 80R Columns—provide the ultimate flexibility in pre-packed column technology. The resin recovery port allows operators to clean and reuse the resin in the OPUS column or a traditional self-packed column.
Customize with flexible add-on services
Used resin packing and repacking service
Repligen now offers used resin packing and repacking services. We will repack cleaned and sanitized used resin from used OPUS columns or other pre-packed or self-packed columns. Upon receipt of the cleaned and sanitized resin, we will quarantine the resin and column while on site and pack the resin into new OPUS column hardware, qualify the column, and return it to you. Contact us to learn more about our used resin packing and repacking service.
Gamma-irradiated chromatography columns
Ensure final product purity and safety using gamma-irradiated OPUS 2.5-30 cm columns to reduce bioburden risk. Gamma-irradiated columns comply with regulatory standards for product quality and safety and maintain consistent column performance.
- Ideal for large biomolecules where sterile filtration is not an option, including viral vectors, gene therapies and cell therapies
- Risk mitigation to ensure product quality and patient safety
- Plug-and-play solution for continuous downstream processing
- Sterility assurance to eliminate bioburden contamination risk
- Facilitated GMP to align to industry best practices
Chromatography redesigned
Optimize your chromatography workflow with innovative solutions designed to improve product recovery and purity while enhancing operational efficiency. See how Repligen chromatography solutions are designed to work together to improve your downstream process productivity.
- Repligen has two Column Shelf Life studies to support the various sizes within the OPUS product line:
|
|
Column Family |
Column IDs Tested |
Tube design |
Time period |
Status |
|
Study 1 |
OPUS® Pre-packed Chromatography |
OPUS® Pre-packed Chromatography |
Polypropylene |
18 months |
Complete |
|
Study 2 |
OPUS® Pre-packed Chromatography |
OPUS® Pre-packed Chromatography |
70% w/w |
60 months |
On-going 36-month time point complete |
- Repligen is currently executing a 5 year stability study for the OPUS 80R Column design. Draft stability memo showing the data for the most recent test point may be provided upon request
- Customers can justify extension of column use through trending of process data
- See Section 2.9 in RSF for additional information
- Repligen reports the following safety pressure ratings for the OPUS® hardware only:
- OPUS® 2.5 - 30: 4 bar
- OPUS® 45 - 80R: 3 bar
- The operating pressure limit for your packed OPUS® Pre-packed Column will be lower than the OPUS® hardware safety pressure rating. To maintain the stability of the packed bed, Repligen suggests operation of your OPUS® Pre-packed Column below the reported maximum packing pressure
- Maximum packing pressure is reported on the column label and the CoA
- Repligen’s OPUS® Pre-packed Columns are shipped in custom boxing or crating depending on the size of the column. Each column is shipped in a recognized bacteriostatic agent based on the approved Specification Sheet (typically 20% Ethanol). Repligen OPUS® Pre-packed Columns are tested under ISTA shipping guidelines as detailed in Section 4. Shipping Qualification of the OPUS® Regulatory Support File (RSF)
- Unpackaging guides are available on the Repligen website
- Repligen packs > 250 resins from 60 resin families >15 resin vendors. The most frequently packed resins are 30-120μm in particle size and based on matrices of agarose, methacrylate, cellulose, and polystyrene material
|
Affinity Repligen CaptivA® and CaptivA® HF |
IEX/Mixed Mode Resin Purolite Praesto® (IEX) |
|
- If a customer requests an OPUS® Pre-packed Columns packed with a resin not included on the list, a packing study will be considered for evaluation of the resin packing and testing parameters.
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