AVIPure® AAV Affinity Resins

AVIPure^® AAV Affinity Resins provide capture step purification of adeno-associated virus (AAV) 2, 5, 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.

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High performance at a lower price point

AAV process cost reduction

~20% lower resin cost/L
> 20 cycle re-use, NaOH stable
High binding capacity, yield, purity

Speed to market

Pre-packed or loose resin

Available now: AAV2, AAV5, AAV8, AAV9
Available pre-packed in OPUS^® Columns

专业制造能力

安全供应

Redundant manufacturing at 3+ sites
Worlds largest ligand manufacturer at 4+ sites
10+ year supply agreements

HIGH PERFORMance

High performance at a lower price point

AVIPure^® AAV 2, 5, 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 simplify processes and dramatically improve overall process economics.

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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

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.

填料	残留 HCP	残留 DNA
AVIPure® AAV2 Resin	4400 ppm	2400 ppm
供应商 A	33000 ppm	4000 ppm

AVIPure^® AAV2 Resin delivered purified product with 1.5X lower residual DNA and fewer impurity proteins by SDS-PAGE.

泳道	样品
1	AVIPure® Elution
2	AVIPure® NaOH CIP
3	竞品洗脱液
4	竞品 NaOH CIP

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.

使用预装、预质量确认的OPUS^®层析柱，可使您在数周内从开发进入生产规模。

OPUS^® Pre-packed Columns

AVIPure® AAV2, 5, 8, 9 Resin characteristics

类别	Description
基质	交联琼脂糖，球形
粒径 (d _{50 V} )	~ 50 µm
配基	AAV2, AAV5, AAV8: Alkali-tolerant recombinant protein (animal free) AAV9: 耐碱多肽（合成）
偶联化学	AAV2: Thiol AAV5: Epoxy AAV8 and AAV9: Carbamate
Binding capacity	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
缓冲液兼容性	对所有常用的水性缓冲液稳定，包括 8 M 尿素、6 M 盐酸胍、乙二醇和去污剂
溶剂兼容性	水、乙醇 (0–20% v/v)、乙腈、1–2 M 乙酸、其它常见有机溶剂
pH 稳定性	1-13
在线清洗稳定性	0.1-0.5 M NaOH
压力/流速 ^a	3 bar @ >300 cm/hc
最高压力 (ΔP)a	40 psi
温度稳定性	2–40 °C
发货状态	2 % 苯甲醇
储存	2–8 °C, 2% benzyl alcohol or 18-20% ethanol; do not freeze
^a 2.6 x 20 cm层析柱，以4 bar压力装柱

层析

ATMP

RGEN

Manufacturing Centers of Excellence

Repligen在ISO 9001质量管理体系下开发和生产用于生物制药行业的产品。我们专注于及时交付高质量、一致且稳健的产品，以确保我们客户的业务连续性。

Repligen manufacturing sites are located in Massachusetts, California, and New Jersey in the United States and in Sweden, France, The Netherlands, Germany and Estonia.

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