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AVIPure® CH1 Affinity Resin

Next generation NaOH stable AVIPure® CH1 Affinity Resin offers superior binding capacity and caustic stability enabling reuse for more than 50 cycles.

high capacity, NaOH tolerant affinity chromatography resin

AVIPure® CH1 Affinity Resin from Repligen is a cross-linked agarose-based resin specifically engineered for the capture of the CH1 region of antigen binding fragments (Fabs) from human immunoglobulins (IgGs) and monoclonal antibodies (mAbs). AVIPure® CH1 Resin delivers dynamic binding capacities of ~50 grams of IgG1 and Fab per liter of resin at standard process flow rates and residence times.

more than 50 cycles of consistently high yield

AVIPure® CH1 Affinity Resin has superior binding capacity and caustic stability enabling reuse for more than 50 cycles.

AVIPure® CH1 Affinity Resin was used to purify Trastuzumab from CHO HCCF over repeated cycles.

  • Column dimensions: 0.3 x 10 cm ​
  • IgG titer: 0.8 g/L ​
  • Resin challenge: 36 g/LRES ​
  • Elution buffer: 100 mM glycine, 150 mM NaCl, pH 3 ​
  • CIP: 0.1 M/0.5 M NaOH, 1 M NaCl, 3.5 hour hold – equivalent to 14 simulated CIP cycles

HIGH BINDING CAPACITY FOR mAb AND Fab FRAGMENTS

The dynamic binding capacity of AVIPure® CH1 Affinity Resin was tested at 0.5 to 10-minute residence times with purified Fab and Trastuzumab IgG1 biosimilar at 2 mg/mL. AVIPure® CH1 Resin demonstrates high binding capacity for Fab and IgG1 even at short residence times.

Resin Characteristics

Characteristics

Description

ベースマトリックス

Cross-linked agarose, spherical

リガンド

Alkali-tolerant recombinant protein (animal free)

Average particle size

~85 µm

Coupling chemistry

Epoxy

Maximum flow velocity

350 cm/hr

Operational pressure

≤1.5 bar deltaP

動作温度

2 - 30 °C

Delivery conditions

Shipped ambient​
50% slurry in 18% ethanol

pH stability

2~13

Storage conditions

18 - 20% ethanol

Storage temperature

2 - 8 °C, do not freeze

 

AVAILABLE PRE-PACKED IN OPUS® COLUMNS FOR QUICK DEPLOYMENT

AVIPure® CH1 Affinity Resins are available in pre-packed and pre-qualified OPUS® Columns for rapid GMP implementation as well as in loose resin formats.

OPUS® Columns allow you to progress from development to manufacturing scale in weeks, using pre-packed and pre-qualified chromatography columns.

ABOUT OPUS® COLUMNS

Custom affinity resin development available

Traditional custom affinity resin development methods start with one scaffold, explore limited ligand sequence space and struggle to deliver consistent results, ultimately requiring multiple iterations that extend the overall timeline. By starting with more than 50 multifarious scaffolds, Repligen generates unprecedented library diversity to achieve high binding capacity, selectable pH requirements and caustic stability on the first iteration at an unparalleled success rate.

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Development and manufacturing excellence

Repligen develops and manufactures products for the biopharmaceutical industry. We focus on the timely delivery of high quality, consistent and robust products, to ensure business continuity for our customers.

ABOUT REPLIGEN MANUFACTURING

Avitide, a Repligen company, is an ISO 9001:2015 certified resin manufacturer and supplier of custom affinity purification resins based in Lebanon, NH. Redundancy is built into the manufacturing model across the U.S. and Europe, with multiple resin warehousing locations, multiple qualified resin production facilities, and multiple ligand production facilities.

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