Repligen is now the only supplier with column packing capabilities on two continents with the new OPUS® Manufacturing Center of Excellence in Breda, The Netherlands.
Repligen Breda simplifies European supply chain logistics by enabling regional column packing. Global customers realize benefits of expanded manufacturing capacity for OPUS® Columns.
Site-to-site equivalence and harmonized quality management systems ensure OPUS® 2.5 to 80R Pre-packed Columns are equivalent in fit, form, and function whether they’re packed in North America or Europe.
Column packing in Europe, for Europe eliminates cumbersome import/export documentation requirements associated with trans-Atlantic transportation of resin and columns.
OPUS® Manufacturing Center of Excellence in Breda, The Netherlands increases annual column production capacity by 70% and expands OPUS® Column manufacturing footprint by 60%.
Introducing OPUS® 2.5 Pre-packed Column
OPUS® 2.5, 5 and 8 Pre-packed Chromatography Columns enable process validation and small-scale GMP manufacturing with column volumes ranging from 25 mL - 1.5 L. Manufacturing standards established for the OPUS® family, including bioprocess compliant product contact materials and ISO documentation, are maintained for scaled-down 2.5, 5, and 8 cm inner diameter (ID) columns. Individual column testing facilitates product-specific certificate of analysis that includes asymmetry, theoretical plates, and maximum packing pressure.
Access OPUS® 2.5 - 80 Pre-packed GMP-ready Columns
OPUS® Pre-packed Chromatography Columns provide linear scale-up from process validation to commercial and GMP manufacturing. Select from the broadest portfolio of pre-packed GMP-ready column sizes, including large scale OPUS® 45R, 60R, and 80R Columns. Pre-packed columns enhance facility efficiency overall by converting column packing resources into productive chromatography and accelerating campaign turnaround time.
Innovation in Purification
Column volume from 25 mL to 150 L. Bed height from 5 cm to 30 cm, configured to the mm
Select from > 150 resins for OPUS® 2.5 – 80R Columns
12 internal diameters and customized column volume
Receive column pre-packed and ready to use
Eliminate up front capital expenses. Convert column packing resources to productive chromatography
ISO documentation supports new product implementation
Repligen develops and manufactures products for the biopharmaceutical industry under an ISO 9001 quality management system. We focus on the timely delivery of high quality, consistent and robust products, to ensure business continuity for our customers.
Select from > 150 resins for OPUS® 2.5 – 80R Columns. Resins may be customer-supplied or Repligen-supplied. A convenient resin pick-up service is available upon approval.
|Partial List of Resins for OPUS® 2.5 - 80R|
IEX/Mixed Mode Resin
Purolite®: SP 45, Q65, Q90
All trademarks are the property of their respective owners.
Ceramic hydroxyapatite (CHT™) resin offers unique selectivity during the purification of mAbs and recombinant proteins. OPUS® Columns can now be pre-packed with CHT™ resin and shipped world wide with excellent performance.
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.
In response to the need to scale up chromatography processes, Repligen offers the largest pre-packed columns for the bioprocess industry. OPUS® 45R, 60R and 80R Columns are the first pre-packed columns designed to meet the chromatography requirements of larger 1000L and 2000L single-use bioreactors.
Introducing OPUS® 80R, the latest innovation from the Leader of the Pack
The first and only 80 cm diameter pre-packed column, OPUS® 80R can be configured with bed heights from 10-30 cm and is capable of purifying over 10 kilos of protein in a single cycle.
|OPUS® 45R||OPUS® 60R||OPUS® 80R|
|Internal diameter||45.7 cm||59.9 cm||79.9 cm|
|Column body pressure rating||3 bar||3 bar||3 bar|
|Bed height range||10 - 30 cm||10 - 30 cm||10 - 30 cm|
|Column volume: 20 cm bed height||33 L||56 L||100 L|
|Assembled column height||≤ 20 cm BH: 90 cm (35 in)
> 20 cm BH: 116 cm (45 in)
|≤ 20 cm BH: 93 cm (37 in)
> 20 cm BH: 120 cm (47 in)
|≤ 20 cm BH: 97 cm (38 in)
> 20 cm BH: 123 cm (48 in)
|Assembled column width||47 cm (18 in)||61 cm (24 in)||81 cm (32 in)|
|Assembled column depth||54 cm (21 in)||68 cm (27 in)||91 cm (36 in)|
|Inlet/Outlet flow path internal diameter||12.7 mm (0.5 in)||19.1 mm (0.7 in)||19.1 mm (0.7 in)|
|Inlet/Outlet port connection (per ASME BPE standards, current ed.)||½" sanitary connector||1" sanitary connector||1" sanitary connector|
|Estimated weight @ 20 cm BH||68 kg (150 lbs)||160 kg (350 lbs)||310 kg (690 lbs)|
From pre-packed to unpacked
With an innovative side port that allows for easy resin unpacking, OPUS® 45R, 60R, and 80R Columns provide the ultimate flexibility in pre-packed column technology.
Without compromising chromatographic performance or cleanability, the new feature helps mitigate the risk of implementing pre-packed columns in GMP settings, and allows for re-use of the unpacked resin in other columns.
Simple unpacking procedure
A simple procedure allows for complete recovery of resin in ≤ 5 column volumes. The OPUS® 45R, 60R, and 80R unpacking procedure includes the introduction and cycling of liquid and air between the existing column inlet and outlet ports. The process is repeated until only air is evacuated from the unpacking port.
Watch the video to see how an OPUS® 60R Pre-packed Column is unpacked.
Substantial savings in manufacturing costs and labor are realized because OPUS® Columns offer the benefits that come with pre-packed technology:
The OPUS® Calculator can help you estimate how much you can save when using OPUS® columns in your specific application.
In this example, over 65% cost savings and up to 80% labor savings were achieved when using OPUS® Columns compared to self-packed columns.
OPUS® Columns are the result of expert engineering combined with deep industry knowledge and experience in downstream chromatography.
OPUS® Columns are designed for use in GMP environments for the manufacturing of clinical and commercial biologic drugs.
From quote request to routine use in GMP processes, OPUS® Columns go through rigorous quality control and validation.
A convenient resin pick-up service is available upon approval.