Clarification for Plasmid DNA

Product catalog summary

Background
The document discusses the increasing demand for plasmid DNA due to the rise in gene and cell therapies, particularly for immunotherapies using modified T cells. This demand is driven by the clinical success and the growing number of late-phase clinical studies, necessitating larger manufacturing capacities and new technical solutions for cell therapy and viral vector production.

Clarification by Alluvial Filtration
The document introduces the PURADISC® BIO SD system as a state-of-the-art technology for alluvial filtration, which is crucial for the clarification of plasmid DNA. This system uses depth filters to capture contaminants and is enhanced by adding filter aids like diatomaceous earth to increase filtration capacity.

The Challenge
The main challenge in plasmid DNA production is the removal of cell debris and impurities during the first clarification step. Traditional methods involve multiple steps, such as centrifugation followed by depth filtration, which can be inefficient.

The Solution
The PURADISC® BIO SD system offers a streamlined solution by eliminating the need for a two-step approach, thus reducing impurities and simplifying the process. It is linearly scalable, allowing for easy transition from process development to large-scale production.

Product Specifications
The document provides a detailed table of product sizes and their best uses, ranging from lab scale to bio process scale, with batch sizes from up to 2 L to 1000 L.

Filter Presses and Module Housings
The PURADISC® BIO SD system is used with DISCSTAR® BIO SD pressure housings, which are available in various sizes to accommodate different production scales.

Catalog excerpts

CLARIFICATION SOLUTIONS FOR •PLASMID DNA r* DEPTH FILTRATION FOR VALUABLE LIQUIDS. SINCE 1938.

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Clarification of Plasmid DNA The Background The increased use of gene and cell therapy, e. g. for immunotherapies with modified T cells, leads to a higher demand for recombinant viral vectors. These types of therapies are based on the use of adeno-associated viruses (AAV), lentiviruses or other virus types. Plasmid DNA is used here as starting material for the transient expression. Due to the clinical success and the growing number of late-phase clinical studies, the demand for plasmid DNA is increasing too. As a result, there is a need for larger manufacturing capacities. In order to meet the...

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The Solution The PURADISC® BIO SD system is the state-of-the-art technology for alluvial filtration. It is based on depth filters that capture contaminants in their three-dimensional matrix. The used PURAFIX® depth filter sheets are low in extractable ions and pyrogens. By adding filter aid, such as diatomaceous earth, the capacity per m2 filter area can be drastically increased. Product Size Description Batch size Best use PURACAP® BIO SD 2" Capsule Lab scale PURACAP® BIO SD 5" Capsule Small pilot scale PURACAP® BIO SD 10" Capsule Pilot scale PURADISC® BIO SD 12M Module Pilot scale Process development,...

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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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Clarification for Plasmid DNA

Clarification for Plasmid DNA

Catalog excerpts

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