Fully disposable process stream

The disposable bioprocessing market has moved far beyond plastic bags for buffer preparation toward a range of products for cell culture and upstream and downstream operations, reports Genetic Engineering & Biotechnology News (GEN). Increasing numbers of biomanufacturing experts now believe that a completely disposable bioprocess stream is feasible and even within reach, according to the March 1 issue of GEN (www.genengnews.com/articles/chitem.aspx?aid=2818).

"It should come as no surprise that bioprocess disposables are rapidly gaining in popularity within the industry as their use minimises expensive validation studies and avoids many costly sterilisation and cleaning procedures," says John Sterling, Editor in Chief of GEN.

The largest hurdles remaining relate to disposable technology development in the areas of biosensors and chromatographic purification. Progress is being made in these areas, though, and the discussions have shifted from the challenges to an emphasis on the opportunities disposable products provide, especially in terms of ease of use, flexibility, maximising infrastructure utilization, in addition to cost savings, environmental impact.

For example, GE Healthcare offers its ReadyMate^TM line of genderless disposable connectors. By eliminating the need to stock both male and female connectors, inventories can be reduced by half, according to the company.

Pall's Allegro^TM line of disposable products for small- to large-scale processing includes Kleenpak^TM Nova capsule filters. Single-use Kleenpak Connectors, each composed of a male and a female connector, are used to link two separate presterilised fluid pathways. The company's Allegro 2-D biocontainers range in size from 50 mL to 50 L, while Allegro 3-D biocontainers and accompanying front-loading stainless steel totes are available in 100 L, 200 L, and 500 L sizes and contain a sampling port and two inlet top ports.

Sartorius Stedim Biotech recently added to its BioStat® CultiBag family of products, introducing three new products, including the CultiBag RM 600, a 600 L disposable bioreactor with a 300 L working volume. The CultiBag RM relies on the motion created by a rocking platform for mixing. It is designed for seed production or GMP manufacturing in batch or fed-batch mode. The 3-dimensional bag contains optical chemical sensors for pH and dissolved oxygen in the form of immobilised, disposable sensor patches. Also new from Sartorius is the CultiBag RM Twin-Rocker, which consists of two rocker units that can be controlled independently by a single BioStat RM Control Tower.