Bioprocess Filter 411: A Look at New Products for 2012

Solution providers churn out new and improved products in the heated market for upstream and downstream filtration technology.

Sartorius Stedim’s Sartoguard PES double layer pre-filters were introduced in 2010 as a means to protect 0.1 and 0.2-μm sterilizing grade filters. The Sartoguard GF is a new addition to the pre-filter portfolio, offering depth+membrane based pre-filters (in addition to membrane-only pre-filters). The GF features three layers of glassfiber (GF) upstream fleece pleated with heterogeneous double-layer PES membranes. The result, Sartorius says, is high total throughput and excellent clarification capability in pre-filtration. Applications include: cell culture media, viscous buffers, serum and serum-supplemented media, and large-volume parenterals.

3M Purification has rounded out its Zeta Plus Encapsulated Depth Filter platform to enable consistent use and scalability from lab to pilot to large-scale commercial production. 3M exhibited the new scale-up filters (up to 50 L) at the recent Interphex show, and also discussed its position as a provider of full solutions for process and environmental filtration, as well as single-use storage equipment, endotoxin removal, bioprocess monitoring tools, and more.

Pall Corp. displayed its Allegro Single-Use Tangential Flow Filtration System prominently at the recent Interphex show in New York. The Allegro, Pall notes, is designed specifically for the incorporation of single-use components. “It is not a disposable version of a traditional TFF system design” and emphasizes ease of use and allowing operators access to components from one side of the system.

In TFF, cleaning of the casettes and system is difficult but essential. The Allegro system, Pall explains, has five attached manifolds—feed, retentate, permeate, retentate biocontainer and recovery—which are gamma irradiated and ready to install. The single-use flowpaths have, where possible, incorporated single-use sensors for tracking of key process parameters and out-of-spec notifications. The Allegro TFF is suitable for ultrafiltration and diafiltration (UF/DF). Typical applications are concentration and diafiltration of proteins, recombinant molecules, potent biological and cytotoxic drugs, and vaccines.

The IBD In-Line Buffer Dilution systems from Asahi Kasei Bioprocess are geared towards simplifying and speeding buffer prep. The IBD systems rely upon process analytical technology (PAT) to provide conductivity and pH feedback control. More robust buffer production leads to faster capture, polishing, virus filtration, and fill/finish for downstream processing. In addition, says AK Bio, the compact footprint and disposable buffer bags are a smart replacement for large buffer tanks. Individual systems can be customized based on specific process requirements, the company says.

EMD Millipore (aka Merck Millipore outside the U.S.) has just added the Millistak+ µPod filter to its portfolio of disposable depth filter systems. The 23-cm2 filter is designed for process development screening for depth filter selection and optimization. Users can connect multiple devices in parallel or series to screen combinations of media, the company says. “The flexible, modular format of the product line ensures that the clarification process is easily scalable from 5 to 12,000 liters or more,” says Inese Lowenstein, the company’s Director for Downstream Processing. Applications include primary and secondary clarification, including cell cultures, yeast and E. coli lysates post centrifuge, E. coli refolds, media, vaccines, plasma proteins and sera.

Also new from Millipore, the Samplicity Filtration System is considered a high-throughput alternative to syringe-tip filters for chromatography sample prep. It is vacuum-driven and designed to filter 1 to 8 samples directly into standard HPLC vials.

Meissner's new UltraSnap filter assembly “conveniently secures multiple pre and final filters into a single-use filtration system for plug and play use.” The system, which comes pre-assembled, is best for clarification through sterile filtration applications. Because of its scalability, UltraSnap allows for flexibility to accommodate various flow capacities, throughput volumes, and retention efficiencies. and effectively makes the scale of single-use filters unlimited.

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