products
AVIPure AAV and HiPer AAV Affinity Resins
Capture AAV vectors with confidence using a portfolio of affinity resins designed for high-productivity process development and validated GMP manufacturing. AVIPure® AAV and AVIPure HiPer™ AAV resins enable efficient, scalable purification while supporting flexibility for your process needs.
Powered by Bioz
product features
Superior performance
High dynamic binding capacity
High target molecule purity and complete elution at pH 3.0
Innovative base bead technology
Improved process productivity
Efficient mass transfer at fast flow rates
Only 30-60 seconds residence time
Enables rapid AAV capture and reduced overall process time
Stability and scalability
Retains over 80% DBC after 10 hours exposure to 0.5 NaOH
Designed to scale easily from process development to commercial manufacturing
A portfolio of AAV capture solutions
AVIPure® AAV affinity resins are now available in high-performance HiPer™ formats for high-productivity processing. HiPer resins use innovative macroporous bead technology optimized for speed and productivity. Choose AVIPure HiPer resins for faster processing with short residence times (30-60 seconds), high throughput, and next-generation process development and scale-up.
The original AVIPure AAV affinity resins are built on a cross-linked agarose base bead and have a long track record of proven performance in GMP manufacturing environments. These resins remain available for continuity in established processes.
AVIPure HiPer AAV Affinty Resins
Next-generation performance with macroporous bead technology
AVIPure HiPer resins are built on an innovative macroporous base bead that enables convective flow both around and through the bead. This design maximizes mass transfer and supports:
- High dynamic binding capacity at short residence times
- Rapid processing at high flow rates
- Improved productivity for modern AAV manufacturing workflows
These large pores are ideal for the purification of large-molecule biologics, such as viral vectors, viruses, and nucleic acids.
AVIPure HiPer resins are currently available for AAV8 and AAV9, with additional serotypes in development.
AVIPure AAV Affinity Resins
Proven performance on agarose matrix
The previous generation of AVIPure AAV affinity resins meet or exceed the performance metrics of resins developed on alternative platforms with the additional benefit of robust alkaline stability.
These resins are designed for:
- Simplified processes and improved process economics
- Alkaline stability through cleaning-in-place (CIP) procedures
- Reliable performance across extended resin lifetime
These resins are available for AAV2, AAV5, AAV8, and AAV9 to support continuity in GMP manufacturing processes.
Serotype availability by resin platform
AVIPure HiPer AAV9 affinity resin performance
The AVIPure HiPer AAV9 affinity resin consistently delivers higher binding capacity (1.0E+15 at 30 seconds residence time) compared to a leading commercial AAV affinity resin, even at fast flow rates, allowing for faster processing. This resin demonstrates a sharp breakthrough curve, translating to minimal loss of valuable capsid material.
Dynamic binding capacity of AVIPure® HiPer™ AAV9 resin vs. leading commercial resin, “Resin T,” after 30 seconds residence time and 60 seconds residence time. Dynamic binding capacity is expressed as 5% breakthrough.
The AVIPure HiPer AAV9 resin delivers robust, reliable performance. Yield, log reduction of host cell protein, and amount of residual ligand remain consistent over 20 product cycles.
Analytical methods:
Titer: Progen AAV9 XPress ELISA
Yield: Progen AAV9 XPress ELISA
HCP purity: Cygnus HEK293 HCP ELISA
HCDNA purity: ThermoFisher Quant-iT
HMW aggregates: HP-SEC, Phenomenex Biozen dSEC-7, 700 Å, 3 µm, 150 x 4.6 mm
Residual ligand: Cygnus Avitide AVIPure® – AAV9 Residual Ligand Assay Kit - (F970)
The AVIPure HiPer AAV9 affinity resin maintains high performance through extended clean-in-place (CIP) cycles. It can withstand at least 10 hours of exposure to 0.5 M NaOH, while retaining 80% of the initial dynamic binding capacity.
The AVIPure HiPer AAV9 resin proves effective for use in direct capture, without requiring a pre-concentrating tangential flow filtration (TFF) step. It delivers excellent recovery in direct capture, reducing overall processing time and supporting process efficiency.
AVIPure HiPer AAV8 affinity resin performance
AVIPure HiPer AAV8 resin retains high binding capacity even with fast flow rates. The resin demonstrates a dynamic binding capacity of 4.2E+14 at 1 minute residence time and 3.8E+14 at 30 seconds residence time.
The AVIPure HiPer AAV9 resin delivers robust, reliable performance. High yield and high impurity clearance remain consistent over 10 product cycles.
The AVIPure HiPer AAV8 affinity resin can be sanitized with up to 0.5 M NaOH, retaining 80% of the initial binding capacity after 5 hours of exposure to NaOH. Additionally, no salt is required for complete elution at pH 3. However, salt can be included using a lower pH if needed.
HiPer resins offer a two-step capture and polish solution
When paired together, AVIPure HiPer AAV affinity resins and the HiPer QA resin form a two-step solution for AAV capture and polish. Unlike other commercial resins, the HiPer QA resin is designed specifically for the polish step of AAV manufacturing and achieves separation of empty vs. full capsids containing the target AAV genome. This two-step purification process results in high purity—without sacrificing process efficiency—to support safety and efficacy in gene therapy manufacturing.
AVIPure AAV resin performance on agarose matrix
The agarose-based AVIPure AAV affinity resins combine high binding capacity with robust chemical stability, making them a trusted choice for long-term manufacturing processes.
Key performance attributes:
- Maintain high host cell protein (HCP) clearance and residual DNA clearance levels after 20 cycles
- Across life of the resin using 0.1 to 0.5 M NaOH for routine cleaning and sanitization
- High dynamic binding capacity even at short residence time enables use with pre-concentrated feed or direct capture:
- >2 x 1014 vp/mLresin at 1 minute residence time
- >7 x 1014 vp/mLresin at 4 minute residence time
Impact of Low pH Affinity Chromatography Elution on AAV Transduction
Affinity chromatography enables effective AAV purification for gene therapy, but the use of acidic pH (pH 2–3) for elution raises concerns about virus stability. Studies across different pH conditions and temperatures showed minimal impact on infectivity at 25°C, with some aggregation and loss of infectivity for AAV8 at 40°C. Throughout downstream purification, virus aggregation was linked to capsid concentration rather than the capture process, and immediate pH neutralization after elution helps mitigate stability risks.
Retain performance with NaOH CIP regeneration
Overlay of every fifth cycle from a single AVIPure® AAV2 column used in a 31-cycle study demonstrating robust chromatographic performance after cleaning in place with NaOH. Total NaOH exposure time at final cycle was 15 hours.
Consistently high yield and clearance of host cell protein (HCP) and host cell DNA (hcDNA) were achieved across 31 cycles on a single AVIPure® AAV2 column. Yield was measured using commercially available AAV2 Progen ELISA kits, HCP was measured by HCP ELISA, and hcDNA was measured by Picogreen assay. Average yield was 105%, average 4.0 log reduction of HCP to 977 ppm, and average 2.8 log reduction of hcDNA to 400 ppm.
Bind with 2-minute residence time, Clear more HCP and DNA
Bind, wash and elute 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 85% recovery.
AVIPure® AAV2 Resin and a competing AAV affinity resin were run under identical conditions. The eluted product was analyzed for purity by SDS-PAGE, HCP and residual DNA.
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.
Results
AVIPure® AAV2 Resin delivered purified product with 7-fold lower residual HCP.
AVIPure® AAV2 Resin delivered purified product with 1.5X lower residual DNA and fewer impurity proteins by SDS-PAGE.
SPEED TO MARKET
Available pre-packed in OPUS® Columns for quick deployment
AVIPure® 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.
AVIPure® AAV2, 5, 8, 9 Resin characteristics
Related Products
OPUS® Pre-packed Chromatography Columns
Accelerate process development and scale-up with consistent performance, reduced operational complexity, and faster deployment from lab to commercial production.
HiPer™ QA Resin
Designed for the purification of extra-large biotherapeutic molecules, the HiPer™ QA Resin achieves superior resolution of full vs. empty AAV capsids. Using innovative macroporous bead technology, this resin delivers high dynamic binding capacity, ultra-fast processing, lot-to-lot consistency, and high scalability to accelerate speed to market.
Resources
