• Repligen has two Column Shelf Life studies to support the various sizes within the OPUS product line:

• 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: 3 bar
  • OPUS^® 45 - 80R: 4 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

Full resin list

• 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.

• Configurable aspects of the OPUS^® product line are listed in our OPUS^® Regulatory Support File, Section 2.3.  This is generally reserved for options on: 
  • Column diameter 
  • Target bed height 
  • Resin type
  • Testing method
  • Storage solution

• A detailed guide (“OPUS^® Pre-packed Chromatography Columns Connection and Priming”) is located in the Resources section on the Repligen website (https://www.repligen.com/resources/quality#collapse2-6) 

• Please contact Customer Service for logging of application support request
• Repligen technical specialists can support your troubleshooting needs remotely by providing (as needed):
  • Analysis of your process trends
  • Best practices for test method setup and execution
  • Best practices for pump/skid/tubing design
  • Column flow conditioning protocol

• Refer to Materials of construction within Section 2 in RSF for additional detail

Each resin type is given a unique customer property (CP) number, establishing full traceability of customer supplied resin throughout the lifecycle of the OPUS order. Once received, the resin will be released and labeled with the unique CP number. All customer property is stored in a segregated cage in the warehouse until the column is ready for production and all movements throughout the facility are systematically tracked within Resource Planning System. After manufacturing is complete, the column is QA released, and any excess resin will be either disposed or returned based on customer designation.  

• Full protocol found in RSF
• In general, Repligen uses the following approach for slurry preparation and percent solids determination.

1. Exchange storage solution with packing buffer
2. Combine resin bottles in a holding tank if required
3. Pull resin samples for % solids determination
4. Spin samples in a centrifuge
5. Determine average % solids 
6. Assign target compression factor (CF = Target column vol./uncompressed resin vol.)
   • Use empirical past data
   • Resin manufacturer recommendations
   • Repligen R&D recommendations
7. % solids and CF applied to the target column volume calculation for resin volume requirement

Repligen uses Fourier Transform Infrared (FTIR) test analysis to identify each resin lot delivered for packing OPUS^® Pre-packed Columns. The test correlates the unique IR absorbance trend of incoming resin against our library of trends representing > 200 resin types in our database. If the resin sample shows ≥95% correlation to a trend in our library, results will show a positive ID.

• It is not required to test OPUS^® Pre-packed Columns upon receipt to your facility.  Many users release the column to production based on the conforming data of the CoA
• If your internal procedures require an incoming material qualification test of the OPUS^® Pre-packed Column, we recommend that customers consistently test OPUS^® Pre-packed Columns with the agreed upon parameters of the individual column’s Specification Sheet and CoA
• General testing methods for chromatography column are outlined in the OPUS^® User Guide

• Once the column has been properly sanitized, it is then washed with a neutralizing buffer. That neutralizing buffer is collected for our Bioburden and Endotoxin testing once it has reached a constant neutral pH (6-8). Below are the steps listed out on how each sample is tested
• Bioburden is analyzed by a vacuum filtration method
  • The sample is applied to a sterile filter under vacuum and then rinsed with peptone water 
  • The filter is collected aseptically and placed onto Tryptic Soy Agar (TSA) media plate
  • The plate is placed into an incubator at 32C +/- 2C for 5 days
  • An analyst reads the plates at day 3 and day 5 and documents the results
• Endotoxin levels are analyzed using a validated Charles River Endosafe^® MCS system
  • 25μL of the column effluent is loaded onto a 0.5 EU/mL cartridge (purchased from Charles River Lab) and inserted into the Endosafe^® instrument for analysis
  • Once the test is complete, a report is generated, and all results are documented as part of the OPUS^® batch record

Yes. Unpacking of non-compressible media has not been studied and is not recommended. In general, these include Ceramic Hydroxyapatite, controlled pore glass, and silica based particles.

Yes. OPUS^® Pre-packed Columns are compatible with conventional and disposable flow path chromatography systems. For more information about connecting and operating OPUS^® Columns, please refer to the OPUS^® Pre-packed Column User Guides.
 

Solvent compatibility list