For New Modalities －Bionanoparticles Purification－

Among the new modalities that are growing rapidly in recent years, we will introduce the latest applications in the field of purification of “bionanoparticles” such as virus vectors for gene therapy, VLPs, and extracellular vesicles, in which CIM monolith has a great advantage.

An Industrial Purification Platform for AAV

AAV (adeno-associated virus) is the most prominent viral vector platform in the field of gene therapy drugs, which has already been successful in clinical research on many genetic diseases. This poster presents fully scalable non-affinity purification strategy that has been proven to be effective for all AAV serotype tested to date.

（Products）

• 311.8140-2　CIMmultus OH-1 monolithic column（weak HIC）
• 311.6157-2　CIMmultus SO3-1 monolithic column（strong CEX）
• 311.5113-2　CIMmultus QA-1 monolithic column（strong AEX）
• 110.6157-1.3　CIMac SO3-0.1 analytical monolith（strong CEX analysis）

Orthogonal Characterization of AAV Samples by Simultaneous Monitoring of Multiple Analytical Parameters during Chromatography

Fast, accurate and meaningful characterization of cell culture harvests and in-process samples is critical for both process development and for documentation of in-process control. This technical note introduces an example of multifaceted AAV process sample analysis using CIMac SO3-0.1 high-speed ion exchange analytical column in combination with multiple optical detectors.

（Products）

• 110.6157-1.3　CIMac SO3-0.1 analytical monolith（strong CEX analysis）

Fluorescence, Light Scattering and UV Absorbance Detector Calibration Plots of Empty and Full AAV2/8 Capsid Mixtures

AAV vector lots are generally a heterogeneous mixture of empty particles (i.e. do not contain DNA) and full particles (i.e. contain DNA). In this study we show an example of measuring empty/full ratio by using CIMac AAV full/empty-0.1 ion exchange analytical column specially designed for AAV empty/full separation, in combination with multiple optical detection systems (fluorescence, light scattering, UV). The things to be taken into account for accurate empty/full quantification are also discussed.

（Products）

• 110.8503-1.3 CIMac AAV empty/full-0.1 analytical monolith

HEK293-derived Adeno Associated Virus (AAV) Purification: Comparison of Small Scale Laboratory Production towards Industrial Format using Monoliths

Successful process on laboratory scale, such as Cesium chloride purification, lacks scalability when the process is due to be transferred to larger industrial scale. The aim of the study was to develop robust, fast and effective rAAV virus purification platform, which can be used for several AAV serotypes with various inserts. Derived purity of industrial scale monolith purification product was comparable to ICGEB laboratory scale purification.

（Products）

• 411.8140-2　CIMmultus OH-8 monolithic column（weak HIC）
• 311.6157-2　CIMmultus SO3-1 monolithic column（strong CEX）
• 311.5113-2　CIMmultus QA-1 monolithic column（strong AEX）
• 110.6157-1.3　CIMac SO3-0.1 analytical monolith（strong CEX analysis）

Exosome Purification with CIMmultus EV-1 Monolith Column

Exosomes are promising candidates for a wide range of diagnostic and therapeutic applications and the demands for fast, robust, and scalable purification procedures are rapidly increasing. This poster shows the example of purification of cell culture derived exosomes by using CIMmultus EV, a newly designed column for extracellular vesicles.

（Products）

311.5120-2 CIMmultus EV-1 monolithic column（for extracellular vesicles）

* "CORNERSTONE Exosome Process Development Pack" in the document is a discontinued product. Please contact us via Inquiry Form for the details on alternative working conditions.

Purification of Norovirus Virus-Like Particles and Their SEC-MALS Analysis

Virus like particle (VLP) is one of a promising new modalities that many applications for novel vaccines or nanodrugs are developed. In this article, we introduce an example of purification method development for Norwalk virus VLP supported by SEC-MALS in combination with other analytical methods. The appropriate selection for analytical SEC columns in bionanoparticle characterization is also discussed.

（Products）

• 311.5113-2 CIMmultus QA-1 monolithic column（strong AEX）
• Shodex OHpak SB-805 HQ（aqueous SEC column）
  *Please see here for details about Shodex HPLC product.