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Clarification of Viral Vectors

Clarification of Viral Vectors

Clarification of Viral Vectors

Product catalog summary
Background
The document discusses the manufacturing of viral vectors, highlighting two main approaches: scale-out of adherent-cell systems using 2D planar technologies and scale-up of 3D suspension cell cultures in bioreactors. The industry prefers suspension cultures like HEK293 cells due to their ability to grow in serum-free media, enhancing safety and reducing costs. Downstream processing aims to eliminate contaminants from host cells and culture media, moving away from traditional methods like centrifugation due to scalability and labor issues. The FILTROX BIO SD system offers a scalable solution for removing host cells and contaminants.

Challenges
High-density cultures typically run in fed-batch mode, with cell paste harvested and cells lysed through physical or chemical means. The challenge lies in removing cell debris and impurities during clarification. Alluvial filtration is recommended for this step.

Solution
The PURADISC® BIO SD system is highlighted as an advanced technology for alluvial filtration, using depth filters to capture contaminants. The system is scalable from lab to production scale, with various product sizes available for different batch sizes. The use of filter aids like diatomaceous earth prevents filter blockage. The system eliminates the need for a two-step centrifugation and depth filtration process, offering flexible optimization and linear scalability.

Product Variants
The document lists several variants of the PURADISC® BIO SD system, ranging from lab scale (PURACAP® BIO SD 2" Capsule) to bio process scale (PURADISC® BIO SD 16D Module), each suited for different batch sizes and stages of production.

Additional Equipment
The PURADISC® BIO SD system is used with DISCSTAR® BIO SD pressure housings and NOVOX® sheet filters, which are available in various configurations to support different module sizes.
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Catalog excerpts

Clarification of Viral Vectors-1

VIRAL VECTORS DEPTH FILTRATION FOR VALUABLE LIQUIDS. SINCE 1938.

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Clarification of Viral Vectors-2

Clarification of Viral Vectors The Background To manufacture viral vectors, two approaches generally are adopted for culturing purposes: scale-out of adherent-cell systems based on 2D planar technologies and scale-up of 3D suspension cell cultures in different types of bioreactors. The industry appears to favor cells adapted to suspension cultures (e. g. HEK293), which can successfully grow in serum-free media and thus provide an enhanced safety profile and reduced cost of goods. Downstream processing is aimed at eliminating contaminants originating from host cells and culture media. The general...

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Clarification of Viral Vectors-3

The Solution Optimized solutions for viral vector clarification The PURADISC® BIO SD system isthe state-of-the-art technology for alluvial filtration. It is based on depth filters that capture contaminants in their three-dimensional matrix. PURAFIX® depth filters are low in extractable ions and by adding filter aid, such as diatomaceous earth, the blocking of the filter can be avoided. The following table shows all available variants of PURADISC® BIO SD. Product Size Description Batch size Best use PURACAP® BIO SD 2" Capsule Lab scale PURACAP® BIO SD 5" Capsule Small pilot scale PURACAP® BIO...

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Clarification of Viral Vectors-4

Filter Presses and Module Housings PURADISC® BIO SD is used in combination with a pressure housing DISCSTAR® BIO SD. FILTROX offers the corresponding pressure housings for the different module sizes and filter presses for filter sheets. DISCSTAR® BIO SD 12" short support system DISCSTAR® BIO SD 12" double support system NOVOX® sheet filter

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