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AVIPure® - AAV Affinity Resins

AVIPure® - AAV Affinity Resins provide capture step purification of adeno-associated virus (AAV) 2, 8, and 9 vectors with potential alkaline clean-in-place regeneration for improved process economics. A 50 µm cross-linked agarose matrix bead ensures compatibility with standard bioprocess columns and flow rates​.

A BETTER PERFORMING AAV AFFINITY RESIN THAT ALSO REGENERATES

AVIPure® - AAV2, 8, and 9 Affinity Resins meet or exceed the performance metrics of resins developed on alternative platforms with the additional benefit of robust alkaline stability. Affinity resins offer the ability to  simplify downstream processing.  NaOH stable affinity resins can both simplify processes and dramatically improve overall process economics. All three AAV affinity resins have been shown to retain over 95% of their dynamic binding capacity (DBC), host cell protein (HCP) clearance and residual DNA clearance after 20 cycles with a 0.5 M NaOH (30 min) clean-in-place (CIP) step.

  • Clean-in-place with 0.5 M NaOH over 20 cycles​​
  • Achieve high DBC​
    • >1 x 1014  vp/mL DBC with 1 minute residence time​​
    • >1 x 1015  vp/mL DBC with 4 minute residence time​​
  • Receive in benzyl alcohol storage buffer ​​
  • Run high flow rates 3 bar at >300 cm/hr (2.6 x 20 cm column pressure packed at 4 bar

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BIND WITH 2 MIN RESIDENCE TIME, CLEAR MORE HCP and DNA​

Bind, wash, and, elute, trace for direct capture of AAV cell culture feed (not concentrated) stream using AVIPure® - AAV2 Resin. A 2 -minute residence time enabled elimination of an existing pre-concentration step. Product was eluted in 50 mM glycine, 150 mM NaCl, 0.01% P188, pH 3 with 83% recovery.

AVIPure® - AAV2 Resin and a competing AAV affinity resin were run under identical conditions (2 minute residence time) with the eluted product analyzed for purity by SDS-PAGE, HCP and residual DNA. AVIPure® - AAV2 Resin delivered purified product with 7-fold lower residual HCP, 1.5X lower residual DNA and fewer impurity proteins by SDS-PAGE.

Resin

Residual HCP

Residual DNA

AVIPure® - AAV2 Resin 4400 ppm 2400 ppm
Supplier A 33000 ppm 4000 ppm

 

Lane

Sample

1 AVIPure® Elution
2 AVIPure® NaOH CIP
3 Competitor Elution
4 Competitor NaOH CIP

 

RETAIN PERFORMANCE WITH NaOH CIP REGENERATION

Overlay of 20 bind, wash, elute and CIP cycles using a single column and NaOH based CIP (Concentrated HEK293 CCF lysate). CIP was 30 minutes with 0.5 M NaOH. Exposure time of 0.5 M NaOH exposure time totaled 10 hours.

A bind, wash, elute and CIP cycle was repeated 20 times using concentrated HEK293 clarified cell culture fluid. CIP included a 30-minute hold step with 0.5 M NaOH. Yield averaged 95% across the 20 cycles.

A bind, wash, elute and CIP cycle was repeated 20 times using concentrated HEK293 clarified cell culture fluid. CIP included a 30-minute hold step with 0.5 M NaOH. Residual DNA clearance averaged 5 fold across the 20 cycles.

A bind, wash, elute and CIP cycle was repeated 20 times using concentrated HEK293 clarified cell culture fluid. CIP included a 30-minute hold step with 0.5 M NaOH. Yield averaged 95% and HCP clearance averaged 3.4 logs across the 20 cycles.

Resin Characteristics

Category

Description

Base Matrix Cross-linked agarose, spherical
Particle size (d50V) ~ 50 µm
Ligand

AAV2 and AAV8: Alkali-tolerant recombinant protein (animal free)​

AAV9: Alkali-tolerant, peptide (synthetic)

Coupling chemistry AAV2: Thiol​

AAV8 and AAV9: Carbamate
Binding chemistry

Achieve high DBC​

>1 x 1014  vp/mL DBC with 1 minute residence time​​

>1 x 1015  vp/mL DBC with 4 minute residence time​​

Buffer compatibility Stable to all commonly used aqueous buffers, including 8 M urea, 6 M guanidine hydrochloride, ethylene glycol, and detergents
Solvent compatibility Water, alcohol (0–20% v/v), acetonitrile, 1–2 M acetic acid, other common organic solvents
pH stability 1-13
Cleaning-in-place stability 0.1-0.5 M NaOH
Pressure/flowa 3 bar at >300 cm/hr 
Maximum pressure (ΔP)a  40 psi
Temperature stability 2–40 °C
Delivery conditions 2% benzyl alcohol
Storage 2–8 °C, 2% benzyl alcohol; do not freeze
a In a 2.6 x 20 cm column pressure packed at 4 bar

 

AVAILABLE PRE-PACKED IN OPUS® COLUMNS FOR QUICK DEPLOYMENT

AAV 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

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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