Optimized solutions for Plasmid- DNA clarification and purification

PURADISC® BIO SD is the state-of-the-art technology for alluvial filtration for Plasmid-DNA clarification. It is based on depth filters that capture contaminants in their three-dimensional matrix. The used PURAFIX® depth filters 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. 

Save one process step
The main advantage of alluvial filtration for the clarification step of Plasmid-DNA is the elimination of the two-step approach. Due to the increased filtration capacity the traditional approaches such as centrifugation followed by depth filtration or a two-step depth filtration are not necessary anymore. The simultaneous reduction of impurities e.g. HCP is another advantage.

Single-use and traditional approach of clarification

The ongoing optimization of mammalian cell lines and fermentation processes leads to higher cell densities/titers and higher monoclonal antibody (mAb) yields. Due to this optimization also the biomass increases, including cell debris and other impurities, which challenges the clarification/harvest step.

The typical clarification process for mammalian cells and mAb involves a primary and a secondary clarification step. Due to potentially high shear forces and the necessity of this step to remove submicron particles, depth filtration is a mandatory step before transferring the liquid into the downstream. 

Clarification for vaccines – the economic and efficient removal of cell debris and negatively charged molecules with FILTRODISC™ BIO SD and FILTRODISC™ R2U depth filter modules.

The purification of vaccines is a critical step during their complex production process. Cells and cell debris, as well as unwanted contaminants such as host cell proteins (HCPs) and nucleic acids need to be removed, while ensuring an optimal product yield. FILTROX offers a variety of filtration solutions to meet the specific needs for vaccine clarification.

A well-established and efficient technology is alluvial (or body feed) filtration with filter aids such as diatomaceous earth. Lenticular filter modules (FILTRODISC™) can be easily applied to combine the exceptional filtration capacity of filter aids with the advantages of using an enclosed filter housing (DISCSTAR™).

To further optimize pharmaceutical processes, the single use filter modules FILTRODISC™ BIO SD for alluvial filtration and FILTRODISC™ R2U (Ready2Use) for standard depth filtration of less turbid fluids are the best solution for eliminating cross-contamination risks and reducing cleaning validation efforts. This technology is easy to implement and linear scalable from lab to production. 

SPECIFIC IMPURITIES TO REMOVE?

To address the removal of specific impurities, filter sheets containing adsorbants with functional properties such as cationic resins (PURAFIX® CH ZP) and activated carbon (CARBOFIL™) are used.