サポートされていないブラウザが使用されています。
このサイトの一部の機能が正しく機能しない可能性があります。最適なユーザーエクスペリエンスを得るために、このサイトはChrome、Firefox、Safari、またはEdgeで表示してください。

よくある質問 - OPUS® カラム

すべて展開
  • 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
Column 10 - 30cm

OPUS® Pre-packed Chromatography
Column 10, 20, 30

ポリプロピレン

18 months

完備

Study 2

OPUS® Pre-packed Chromatography
Column 45 - 80R

OPUS® Pre-packed Chromatography
Column 80

70% w/w 
E-Glass/PP engineered composite structure

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: 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

     

アフィニティ

Repligen CaptivA® and CaptivA® HF
Repligen NGL COVID-19 Spike Protein AF Matrix
Repligen AVIPure® AAV2, AAV8 and AAV9
Purolite Praesto® AP/AP+, Jetted A50/A50+
Cytiva MabSelect™ Family
Cytiva AVB Sepharose™ HP
Cytiva Capto™ PlasmidSelect
Thermo POROS® CaptureSelect™ AAV/AF types
Thermo POROS® Heparin
Tosho TOYOPEARL® AF-rProtein A HC-650F
JSR Amsphere™ A3
KANEKA KanCap™ A
Various Vendors IMAC/Chelating/Nickel

IEX/混合モード樹脂

Purolite Praesto® (IEX)
Cytiva Capto™ ImpRes (IEX, HIC, MMC)
Cytiva Capto™ (IEX, HIC, MMC)
Cytiva Capto™ Core 400 and 700
Cytiva Capto™ S ImpAct
Cytiva Sepharose™ FF (IEX, HIC, MMC)
Cytiva Sepharose™ HP (IEX, HIC, MMC)
Cytiva SOURCE 30 (Q and S)
Cytiva Superdex (75 and 200)
Cytiva  Sephadex G25
ABT Rapid Run Agarose Bead (IEX)
Thermo POROS® 50 um (IEX, HIC)
Thermo POROS® 20 um (IEX)
 



Tosoh TOYOPEARL® (IEX, HIC, MMC)
Millipore Fractogel® (IEX)
Millipore Eshmuno® (IEX)
Sartorius HyperCel™ (PPA, HEA, CMM, MEP)
BioRad Nuvia™ (IEX, MMC)
BioRad Nuvia™ HP (IEX)
BioRad UNOsphere™ (IEX)
BioRad CHT™ Types: I & II, 40um, 80um, (≤60cm IDs)

 

  • 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 
    • 樹脂タイプ
    • 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

構成部品

素材

USP <88> class

CFR 21 777

Animal origin

Column Tube (OPUS® Pre-packed Chromatography Columns 2.5 - 30 cm ID)

ポリプロピレン

クラスVI

177.1520

Animal Free

Column Tube (OPUS® Pre-packed Chromatography Columns 45/R, 60/R, 80R)

70% w/w 
E-Glass/PP engineered composite structure

クラスVI

177.1520

Animal Free

Flow Distributors
OPUS® Pre-packed Chromatography Columns 2.5 - 80R 

ポリプロピレン

クラスVI

177.1520

Animal Free

Inlet and Outlet Ports for OPUS® Pre-packed Chromatography Columns

ポリプロピレン

クラスVI

177.1520

Animal Free

Bed Support Screens
OPUS® Pre-packed Chromatography Columns 2.5 -80R

ポリプロピレン

クラスVI

177.1520

EMA 410/01

Flow Distributor O-Rings

Platinum-cured medical grade silicone

クラスVI

177.2600

Animal Free

戻り管路

Platinum-cured medical grade silicone, reinforced with strong polyester fiber

クラスVI

177.2600

Animal Free

OPUS® Pre-packed Chromatography Columns R Plug, and Inside Port

ポリプロピレン

クラスVI

177.1520

Animal Free

OPUS® Pre-packed Chromatography Columns R Inner/ Outer Gaskets, and Plug O-ring

Platinum-cured medical grade silicone 

クラスVI

177.2600

Animal Free

Column diameter

Physical Attributes

2.5 cm

5.1 cm

8.1 cm

10 cm

12.6  cm

14 cm

20 cm

25 cm

30 cm

Internal cross section

4.91 cm2

20.4 cm2

51.5 cm2

78.5 cm2

125 cm2

154 cm2

314 cm2

491 cm2

707 cm2

Column hardware maximum pressure

4 Bar

4 Bar

4 Bar

4 Bar

4 Bar

4 Bar

4 Bar

4 Bar

4 Bar

ベッド高さの幅

5~30 cm

5~30 cm

5~30 cm

5~30 cm

5~30 cm

5~30 cm

5~30 cm

5~30 cm

5~30 cm

Column volumes bed height

10 cm

20 cm

30 cm


 

49 mL

98 mL

147 mL


 

0.2 L

0.4 L

0.6 L


 

0.5 L

1.0 L

1.5 L


 

0.8 L

1.6 L

2.4 L


 

1.3 L

2.5 L

3.8 L


 

1.5 L

3.1 L

4.6 L


 

3.1 L

6.3 L

9.4 L


 

4.9 L

9.8 L

14.7 L


 

7.1 L

14.1 L

21.2 L

Assembled column bed height

~25 + cm

~20 + cm

~20 + cm

~20 + cm

~28 + cm

~30 + cm

~30 + cm

~33 + cm

~35 + cm

Outer diameter (including caps)

6 cm

7 cm

10 cm

16 cm

20 cm

21 cm

27 cm

33 cm

38 cm

流路入口/出口の内径

2.00 mm

5/64 in

3.45 mm

5/32 in

4.57 mm

3/16 in

6.35 mm

1/4 in

6.35 mm

1/4 in

6.35 mm

1/4 in

6.35 mm

1/4 in

9.53 mm

3/8 in

9.53 mm

3/8 in

Inlet/Outlet port connectors

3/4 inch mini Tri-clamp

3/4 inch mini Tri-clamp

3/4 inch mini Tri-clamp

3/4 inch mini Tri-clamp

3/4 inch mini Tri-clamp

3/4 inch mini Tri-clamp

3/4 inch mini Tri-clamp

3/4 inch mini Tri-clamp

3/4 inch mini Tri-clamp

 

 

Column diameter

Physical Attributes

45.7 cm

59.9 cm

79.9 cm

Internal cross section

1,640 cm2

2,818 cm2

5,014 cm2

Column hardware maximum pressure

3 Bar

3 Bar

3 Bar

ベッド高さの幅

10~30 cm

10~30 cm

10~30 cm

Column volumes bed height

10 cm

20 cm

30 cm


 

16 mL

33 mL

49 mL


 

28L

56L

84L


 

50L

100L

150L

Assembled column height (CM)*

≤ 22 cm BH: ~90 cm
> 22 cm BH: ~116 cm

≤ 22 cm BH: ~93 cm
> 22 cm BH: ~120 cm

≤ 20 cm BH: ~97 cm
> 20 cm BH: ~123 cm

Outer diameter (including caps)

54 cm

68 cm

91 cm

流路入口/出口の内径

12.7 mm

1/2 in

19.1 mm

3/4 in

19.1 mm

3/4 in

Inlet/Outlet port connectors
Per ASME BPE Standards, Current Edition

3/4 inch mini Tri-clamp

1 inch Tri-clamp

1 inch Tri-clamp

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
  • 通常、Repligenは以下の手法を使用してスラリー調製および固形率測定を行います。
  1. Exchange storage solution with packing buffer
  2. 必要に応じて樹脂ボトルを貯蔵タンクに入れておく
  3. Pull resin samples for % solids determination
  4. サンプルを遠心分離機にかける
  5. Determine average % solids 
  6. 目標圧縮係数を割り当てる(CF = 目標カラムの用量/非圧縮樹脂容量)
    • 経験的な過去のデータを利用する
    • 樹脂メーカーの推奨事項
    • Repligen R&D 推奨
  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

 

 

 

2 M sodium hydroxide

Sulfuric acid (<50%)

20% Acetic acid

Potassium hydroxide

8 M urea or 6 M guanidine HCI

20% Ethanol

Benzyl alcohol

Methanol

10% Acetone

Isopropyl alcohol (IPA)

Phosphoric acid

2% (w/v) Detergents

Citric acid

HCI (< 20%)