The use of scalable Mustang XT membrane chromatography capsules is a flexible solution for downstream processing that significantly helps process developers improve their process economics:
- Reduce process times through use of high volumetric flow rates.
- Improve process economics through increased throughput and reduced buffer consumption.
- Enhance process flexibility through use of a much smaller operating footprint.
- Increase process capacities by linking units in parallel or series.
Pall has combined its competencies in membrane device design and chromatography to develop a range of high-performance, scalable Mustang Q XT membrane chromatography capsules. These capsules are reliable, easy to use and enable users to significantly improve their process economics through reduced buffer consumption, increased throughput and reduced capital expenditure. Processes benefit from:
- High Binding Efficiency – Mustang Q XT capsules exhibit high capacities and high flow at low pressure drops, allowing binding of charged biomolecules in a single pass.
- Speed – High flow rates enable the processing of large volumes in less than a single working shift. Mustang Q XT5000 capsules typically operate at 10 MV/min flow rates (50 L/min) making membrane chromatography 30 to 50 times faster than conventional chromatography sorbents.
- Scalability and Flexibility – A full range of capsule sizes accommodates various volumes and capacities required in biopharmaceutical processing, from process developmentto full-scale manufacturing. Capsules can be used as single-use or cleaned and reused.
- Reproducibility – Capsules are manufactured using the Six Sigma statistical process control system to ensure reproducible process and conformance to specifications, and enable consistent process performance.
- Convenience – Easy-to-use capsules eliminate need for packing protocols. If used as disposables, there are no cleaning, cleaning validation, or cross-contamination issues.
- Lower Cost – Membrane capsules offer lower operating and capital investment costs than conventional columns that require validated packing and cleaning protocols.
- Reduced Buffer Consumption – Small device footprint requires significantly less buffer yet maintains efficient contaminant removal performance.
Mustang Membrane Technology
Mustang membrane chromatography continues to make advances in chromatographic separations. Its open pore structure eliminates the diffusion limitations of sorbents, allowing biomolecules to access all binding sites by direct fluid convection. This means that high dynamic binding capacities and sharp breakthrough curves are achieved over a very wide range of flow rates and also a large range of molecular sizes.
The Mustang Q XT140 capsule and Mustang Q XT5000 capsule use patented Ultipleat® pleating technology to maximize membrane volume while maintaining a small footprint. This also minimizes hold up volume, which leads to enhanced chromatographic performance with linear or step gradients.
Introducing the Mustang XT Range
Mustang Q XT capsules have been designed for optimum membrane chromatography performance, providing scalability from process development through to full scale manufacturing. Each unit is constructed with the same membrane bed height to maintain scalability for both dynamic binding capacity and pressure drop, and the durable polypropylene housing has been designed to minimize upstream and downstream hold-up volume, to enhance chromatographic performance. The durable housing also provides the flexibility to use Mustang XT devices as single use disposables, or as multi-use devices. Available at this time with Mustang Q chemistry, the Mustang Q XT capsules can be operated at typical flow rates of 10 MV/min, and exhibit excellent dynamic binding capacities for maximum throughput.
In many applications, the dynamic binding capacity of Mustang Q membrane is equivalent to or greater than the equivalent resin chemistries; and unlike sorbents, the dynamic binding capacity is independent of flow rate. In polishing applications, for the removal of low levels of contaminants, this means high flow rates (more than 10 MV/min) and low pressure drops that can be fully exploited with minimum membrane volume. In capture applications, good resolution with high yields and minimal elution volumes are achieved, due also to the characteristics of the membrane, the uniform flow path and the very low total volume-to-membrane-volume ratio which is engineered into the Mustang Q XT capsule.
High Quality Standards
- Manufactured to high quality assurance standards in accordance with ISO 9000
- Membrane lots tested for dynamic protein and DNA binding capacity
- Identified by lot number and a unique serial number for complete traceability of manufacturing history, satisfying stringent QC/QA requirements
- Supplied with Certificate of Analysis to confirm Pall quality standards
- Meets USP biological reactivity tests in vivo in accordance with requirements for USP Class VI-50 °C Plastics and all materials listed in Drug Master File submitted to the FDA
Products in this datasheet may be covered by one or more patents including :
EP 0 667 800
EP 0 982 061
EP 1 380 331
EP 1 163 045
EP 1 614 459
Proven ApplicationsMustang Q capsules with the same membrane technology and smaller membrane volumes are proven in a wide range of approved processes and clinical trials for applications such as:
- Contaminant removal for DNA, virus, host cell protein, and endotoxin
- Plasmid, Virus, protein capture, and oligonucleotide purification
- Column guard to enhance selectivity of subsequent chromatography steps
Scalable Mustang Q XT products meet processing requirements in a range of volumes:
- Mustang Q XT5: 5 mL capsule, for laboratory scale process development work
- Mustang Q XT140: 140 mL capsule, for pilot scale work and small scale clinical manufacturing runs
- Mustang Q XT5000: 5 L process scale capsule, for process scale clinical manufacturing
Materials of Construction
|5 L Process Capsule||140 mL Pilot Scale Capsule||5 mL Scale Down Capsule|
|Membrane||Modified hydrophilic polyethersulfone (PES) membrane||Modified hydrophilic polyethersulfone (PES) membrane||Modified hydrophilic polyethersulfone (PES) membrane|
|Membrane Support and Drainage||Polypropylene||Polypropylene||Polypropylene|
|Core/Cage/Endcaps||Polypropylene||Not applicable||Not applicable|
Mustang XT stand is 316/316L stainless steel.
|5 L Process Capsule||140 mL Pilot Scale Capsule||5 mL Scale Down Capsule|
|Maximum Operating Temperature||38 °C||38 °C||38 °C|
|Maximum Operating Pressure||3 barg (43.5 psig) at 38 °C||3 barg (43.5 psig) at 38 °C||5 barg (75.0 psig) at 38 °C**|
|Maximum Differential Pressure||3 barg (43.5 psig) at 38 °C||3 barg (43.5 psig) at 38 °C||5 barg (75.0 psig) at 38 °C**|
|Storage Conditions||0.1 M NaOH plus 1 M NaCl||0.1 M NaOH plus 1 M NaCl||0.1 M NaOH plus 1 M NaCl|
* With fully compatible fluids that do not soften, swell or adversely affect the capsule or its materials of construction.
** Maximum operating pressure for the Mustang XT5 capsule is 13 barg (196 psig) at 38 °C when used with the XT5 Jacket.
|Part Number||5 L Process Capsule||140 mL Pilot Scale Capsule||5 mL Scale Down Capsule|
|Length without Protective Inlet/Outlet Caps||605 mm (23.8 in.)||190 mm (7.48 in.)||39 mm (1.5 in.)|
|Diameter of Capsule Body (Central Section)||246 mm (9.7 in.)||91 mm (3.6 in.)||91 mm (3.6 in.)|
|Diameter at Inlet/Outlet Ends||270 mm (10.6 in.)||Inlet: 107 mm (4.21 in.) |
Outlet: 90 mm (3.54 in.)
|Diameter Across Flats at Inlet/Outlet Ends||Not applicable||Inlet: 104 mm (4.09 in.) |
Outlet: 86 mm (3.39 in.)
|Weight Dry||10.3 kg (22.7 lb)||768 grams (1.5 lb)||187.2 grams (6.6 oz.)|
|Weight Drained (Wet Membrane)||14.2 kg (31.3 lb)||917 grams (1.8 lb)||191.2 grams (6.74 oz.)|
|Weight in Use (Filled)||19.6 kg (43.2 lb)||1009 grams (2.0 lb)||195.0 grams (6.88 oz.)|
|Connectors||38 mm (1.5 in.) sanitary flange||12.7 mm (0.5 in.) sanitary flange||Female M6 threads|
Mustang XT 5000 Stand
|Height for 1 x XT5000 Capsule||1122 mm (3.7 ft)|
|Height for 2 x XT5000 Capsules||1865 mm (6.1 ft)|
|Height for 3 x XT5000 Capsules||2607 mm (8.6 ft)|
|Base Depth||500 mm (1.6 ft)|
|Base Width||500 mm (1.6 ft)|
Chromatography PerformanceIn most applications the dynamic binding capacity of Mustang Q membrane is equivalent or greater than the equivalent resin chemistries. In polishing applications, for removal of low levels of contaminants this means the high flow rates (more than 10 cv/min) and low pressure drops can be fully exploited with minimum membrane volume. In capture applications, good resolution with high yields and minimal elution volumes are achieved, due also to the characteristics of the membrane, the uniform flow path and the very low total volume to membrane volume ratio which is engineered into the XT capsule.
Flow Rate vs Differential Pressure for Mustang XT5,
Mustang XT140 and Mustang XT5000
High Speed Chromatography
BSA Dynamic Binding and Elution Curve for
Mustang Q XT5000 Capsule at 50 L/min
A solution of 1.2 mg/mL BSA (bovine serum albumin) in 20 mM Tris, ph 8.0 was loaded at a flow rate of 50 L/min and the UV absorbance was monitored at 280 nm. Arrows on the chromatogram indicate where the load, wash, and elute steps take place. Initial breakthrough does not occur until after 4 minutes have elapsed, and full saturation is achieved in 8 minutes. Wash and elution take only 2 minutes. These three steps together take place in less than 10 minutes, and approximately 400 g of BSA were bound and eluted in total.
High Dynamic Binding Capacity
BSA Dynamic Binding Capacity Curve for
Mustang Q XT5000 Capsule at 50 L/min
- Application Note “Purification of Influenza Virus by Ion Exchange Chromatography on Mustang® Q XT Membranes Fast Purification Conditions Screening on AcroPrep™ Advance 96-Well Filter Plates”
- Product Note: Mustang® Q Membrane Chromatography
- Instructions for Use: Mustang® Q XT5, Q XT140, and Q XT5000 Chromatography Capsules - Assembly and Installation Procedures
- Instructions for Use: Mustang® Q XT5000 Stand and Lifting Handle Assembly - Assembly and Installation Procedures
Optimize Your Scale Up with Pall
When it is time to scale up your process, Pall offers a comprehensive range of pilot- and process-scale PK chromatography control systems. PK systems:
- Ensure your purification is consistent and optimal at pilot and manufacturing scales
- Provide flexibility and execution of all biochromatography applications
- Exhibit robust operation from hardware and software
- Cover a range of applications from 10 to 4000 L/h
Pall offers the most comprehensive range of chromatography products for biopharmaceutical manufacturing including scalable sorbents, columns, and systems. Our industry-leading technical support can help to ensure the most efficient development, start-up and lifetime operation of your processes, thereby lowering operating costs.
Mustang XT5000 Membrane Chromatography Capsules
|XT5000MSTGQP1||Mustang Q XT5000, Q chemistry with 5 L membrane volume for clinical manufacturing||1/pkg|
|XT140MSTGQP05||Mustang Q XT140, Q Chemistry with 140 mL membrane volume for pilot scale process development||1/pkg|
|XT5MSTGQPM6||Mustang Q XT5, Q chemistry with 5 mL membrane volume for scale-down process development; the capsule inlet and outlet has female M6 threads and includes connectors and tubing||1/pkg|
|XT5MSTGJKT||Mustang XT5 Jacket, to be used when operating a chromatography workstation that gives inlet pressures in excess of 5 barg (75 psig) when operated at flow rates of 50 mL/min||1/pkg|
Mustang XT5000 Stand
|XT5000T100||Top portion of stand||1/pkg|