Disposables on a grand scale
Disposable membrane capsules offer advantages over packed columns

New methods of chromatography are needed to meet increasing capacity demands and the downstream processing requirements of developing and producing drugs. Pall Corporation has answered this need with the new Mustang XT5000 capsule, which provides greater throughput, superior binding capacity, and fast processing for a wide range of process chromatography applications.

The next-generation ion-exchange membrane capsule extends Mustang chromatography’s uses beyond the removal of contaminants such as DNA, viruses, endotoxins and host cell proteins. It also enables super-efficient capture of large molecules—especially important for the development of new drugs and therapies that utilize recombinant proteins, plasmids and other viral vectors—and blood plasma fractions. With the ability to process large fluid volumes 30 times faster than traditional chromatography resins during capture and polishing steps, the new capsule brings the benefits of Mustang technology to both ends of the process chromatography spectrum.
The 5-liter Mustang XT5000 offers unprecedented time and cost savings as a function of its single-use format, high volumetric throughput, and ability to efficiently process large molecules. It is the largest chromatography capsule available for reliable process performance. As a single-use capsule, the Mustang XT5000 does not require media packing, cleaning or cleaning validation, and it avoids the need for cleaning buffers and costly resin. It also prevents cross-contamination risks. As an integral part of Pall’s extensive portfolio of single-use technologies, the new Mustang capsule brings manufacturers one step closer to completely disposable manufacturing processes.

“Mustang technology will play a critical role in preventing bottlenecks in process chromatography steps as macromolecule drugs move from clinical trial to pilot and full-scale production,” said Dr. Holly Haughney, Vice President, Pall Life Sciences. “The newest Mustang capsule extends disposability into new processing areas that traditionally use conventional columns. Many downstream processes, including chromatography, have been identified as sources of inefficiency in drug manufacturing. Mustang technology overcomes these inefficiencies by increasing through-put, decreasing labor and processing steps, and reducing contamination risks.”
Membrane advantages
The Mustang XT5000 capsule uses Pall’s ion-exchange membrane technology to offer exceptional flowrates and high dynamic binding capacity. Mustang chromatography allows biomolecules to access all binding sites by direct fluid convection. Since the binding is not diffusion-limited, high dynamic binding and sharp breakthrough curves are achieved over a very wide range of flowrates and a large range of molecular sizes. This gives significant advantages over packed columns, especially for high flowrates or large molecules.
The capsule demonstrates good resolution, while providing high yields and mini-mal elution volumes in capture applications as a result of its uniform flow path and very low ratio of total volume to membrane volume. The systems can be configured in series, or in parallel for even higher throughput. Space requirements are low, due to the packing density of the membrane in the capsule and the ability to stack capsules.
To further simplify validation and process development for the Mustang XT5000 capsule, Pall is also introducing the Mustang XT5 capsule, a complementary scale-down unit, which requires small fluid volumes for production support studies. The XT5 capsule has been designed to give a direct scale up to the XT5000 and uses the same materials of construction.