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OPUS® 2.5 - 80R Pre-packed Columns
Manufacturing

 

OPUS® Pre-packed Chromatography Columns provide linear scale-up from process validation to commercial and GMP manufacturing.

OPUS® Columns packed on two continents

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.

OPUS® EU manufacturing center of excellence

OPUS® column packing

in europe, for 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%. ​

Icon_NEW.jpgRun GMP quality OPUS® 2.5, 5 and 8 pre-packed Columns

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.

Leader of the Pack

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

  • Configure bed height to nearest mm
  • Pack nearly any resin from nearly any supplier
  • Customize plat count, asymmetry and test method
  • Unpack resin using recovery port featured on OPUS® 45R, 60R and 80R columns
ANY SIZE

Column volume from 25 mL to 150 L. Bed height from 5 cm to 30 cm, configured to the mm

ANY RESIN

Select from > 150 resins for OPUS® 2.5 – 80R Columns

Ultimate flexibility

12 internal diameters and customized column volume

CONVENIENT

Receive column pre-packed and ready to use

Cost-effective

Eliminate up front capital expenses. Convert column packing resources to productive chromatography

Quality manufacturing

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.

about repligen manufacturing

Scale with opus® Columns

  • Consistent materials of construction
  • Class VI, EMA 410/01 compliant materials
  • GMP and pre-GMP quality packages
  • ISO documentation (CoA, RSF)
  • Select from > 150 resins
  • Individual column release testing

Packed with user-specified resin

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
Affinity    


Affinity

CaptivA®
Praesto® AP, Jetted A50
MabSelect SuRe™ and SuRe™ LX
MabSelect™
POROS™ CaptureSelect™
    AAV8, AAV9, AAVX, FcXL
AVB Sepharose® HP
MabCapture™ A
Eshmuno® A
Amsphere™ A3
KanCap™ A

IEX/Mixed Mode Resin

Purolite®: SP 45, Q65, Q90
IEX Capto™ ImpRes: SP and Q
Capto™ ImpRes: adhere and MMC
IEX Capto™ : Q, S, DEAE
Capto™ adhere, Phenyl, MMC
Capto™ Core 700
IEX Sepharose® FF: SP, Q, DEAE
IEX Sepharose® HP: SP and Q
HIC Sepharose® FF: Butyl and Phenyl
HIC Sepharose® HP: Butyl and Phenyl
Nuvia™ : S, cPrime, HRS



IEX POROS®: 50HQ, 50HS, XS, XQ
HIC POROS®: Benzyl and Ethyl
Fractogel® TMAE, SO3-, COO, DEAE
Fractogel® TMAE HiCap and SE HiCap
Eshmuno®: CPX and HCX
Toyopearl® 650M: Butyl, Phenyl,
   DEAE, Super Q
Toyopearl® 600M: Butyl, Phenyl, PPG
Toyopearl® GigaCap 650M: S and Q
UNOsphere™: S and Q
CHT™ 40µm, 80µm Type I, Type II

All trademarks are the property of their respective owners.

Access CHT™ resin pre-packed in OPUS® Columns

 

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.

  • Internal diameters from 5 - 45 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.

largest scale, broadest range

OPUS® Pre-packed Chromatography Columns

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.

  • Easily configured for bed height, resin, and application
  • Seamless and linear scale-up from smaller OPUS® Columns
  • Complete documentation package for GMP use
  • Significant time and cost savings compared to conventional column technology
OPUS® Pre-packed Chromatography Columns

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.

  • 80 cm internal diameter
  • Includes recovery port for easy resin removal
  • Bed heights 10-30 cm, configurable to the nearest millimeter
  • Resin from any supplier
  • Scaled from the OPUS® 45R and 60R design
  • Optimized flow distribution 
  • No new product contact materials of construction
  • Standard 1 inch tri-clamp inlet and outlet connections
  • Maximum operating pressure 3 Bar, design qualified to >6 Bar
  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)

 

Innovative Resin Recovery Port

OPUS® Pre-packed Chromatography Columns

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.

  • In the event of a deviation, and if the OPUS® pre-packed column performance cannot be recovered, the column can be unpacked and the resin can be repacked into a traditional, self-packed column. 
  • After the intended usage of the OPUS® pre-packed column, the column can be unpacked and resin transferred to a development or pilot setting for additional use.

Watch the webinar

 

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.

impact on process Economics

Substantial savings in manufacturing costs and labor are realized because OPUS® Columns offer the benefits that come with pre-packed technology:

  • No up-front capital expense
  • Reduction of CIP procedures and cross contamination
  • Faster campaign turnaround time
  • Operational excellence (reduced labor requirements)

The OPUS® Calculator can help you estimate how much you can save when using OPUS® columns in your specific application.  

 

Request a Savings Estimate

In this example, over 65% cost savings and up to 80% labor savings were achieved when using OPUS® Columns compared to self-packed columns.

 
Assumptions: OPUS® 60R Pre-packed Column versus purchase of new 60 cm diameter automated self-pack equipment (columns are dedicated to a specific molecule). Data presented are estimates and subject to change.

industry-leading Technology

OPUS® Pre-packed Chromatography Columns

OPUS® Columns are the result of expert engineering combined with deep industry knowledge and experience in downstream chromatography.

  • Unique design features
  • Reliable multi-cycle performance
  • Robust GMP-compliant construction
  • Easy cleaning and sanitization
  • Scalable performance consistent across different sizes
  • Performance maintained after shipping

OPUS® Column Technology

OPUS® Columns for GMP manufacturing

OPUS® Columns are designed for use in GMP environments for the manufacturing of clinical and commercial biologic drugs.

  • Packed in ISO Class 7 clean rooms
  • Complete Regulatory Support File
  • Certificate of Analysis for each column configuration

OPUS® Columns for GMP manufacturing

Order Workflow

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.

 

OPUS® order overview

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