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Plug and Play, Scalable, Reusable Ion Exchange Membrane Chromatography
Meeting Process Demands for Scalability and Economy
The use of ion exchange chromatography for purification in downstream processing is well established. Many regulatory approved processes make use of large process columns packed with ion exchange sorbent for effective and reliable performance. As demand intensifies for improved throughput and reduced processing costs, Pall’s Mustang ion exchange membrane technology keeps pace, enabling process developers to harness:
- Reduced process times through use of high volumetric flow rates.
- Improved process economics through increased throughput and reduced buffer consumption.
- Enhanced process flexibility through use of a much smaller operating footprint.
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 robust, easy to use and enable users to significantly optimize their process by minimizing buffer consumption, increasing throughput and reducing 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 large charged biomolecules such as plasmids and lentiviruses in a single pass.
- Speed – Membrane binding capacity is not significantly affected by flow rate. Mustang Q capsules typically operate at 10 MV/min flow rates (up to 50 L/min for XT5000), enabling membrane chromatography to process much faster than conventional chromatography sorbents.
High flow rates enable the processing of large volumes in less than a single working shift. - Scalability and Flexibility – A full range of capsule sizes accommodates various volumes and capacities required in biopharmaceutical processing, from process development to full-scale manufacturing.
Capsules can be deployed in single-use applications or can be regenerated and reused. - Reproducibility – Capsules are manufactured using the Statistical Process Control (SPC) system to enable the process to be reproduced in a consistent manner.
The consistency of the process ensures conformance to specifications and delivers consistent process results. - Convenience – Easy-to-use capsules eliminate the need for packing protocols. In single-use applications, 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 – The small device footprint requires significantly less buffer yet maintains efficient contaminant removal performance.
Screening and optimization studies can be performed with full confidence as Mustang Q capsules, XT5 to XT5000, are made with the same construction materials and consistent void volume-to-membrane ratio, for scalable chromatographic performance. The XT5 device, is ideal for scale-down optimization studies.
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
Specifications
Table 1
Specifications of Mustang Q membrane in XT Acrodisc® unit
| Part number (P/N) | MSTGXT25Q16 |
| Membrane Bed Volume | 0.86 mL |
| Housing | Polypropylene |
| Media | 16-layer Mustang Q 0.8 μm membrane |
| Connections | Female luer-lock inlet and outlet |
| Maximum Operating Pressure | 4 bar (58 psi) |
| Recommended Connectors for Chromatography Workstation | Luer to 1/4–28 female adaptor (Bio-Rad, part number 732-0113) |
Table 2
Specifications of Mustang Q XT capsules
| Type of Mustang Q XT Capsule |
5 mL Scale Down (P/N XT5MSTGQPM6) |
50 mL Scale Up (P/N XT50MSTGQP05) |
140 mL Pilot Scale (P/N XT140MSTGQP05) |
450 mL Process (P/N XT450MSTGQP05) |
5 L Process (P/N XT5000MSTGQP1) |
| Materials of Construction | |||||
| Membrane | Modified hydrophilic polyethersulfone (PES) membrane | ||||
| Membrane Support and Drainage | Polypropylene | ||||
| Core/Cage/End Caps | |||||
| Housing | |||||
| O-rings | Silicone | ||||
| Valve | Not applicable | Polypropylene | Polypropylene | Polypropylene | Polypropylene |
| Nominal Dimensions | |||||
| Capsule Length Without Protective Caps |
39 mm (1.5 in.) | 132 mm (5.20 in.) | 190 mm (7.48 in.) | 339 mm (13.35 in.) | 605 mm (23.8 in.) |
| Maximum Diameter of Capsule Body |
97 mm (3.8 in.) | 107 mm (4.21 in.) | 107 mm (4.21 in.) | 107 mm (4.21 in.) | 270 mm (10.6 in.) |
| Weight Dry | 187 g (6.6 oz.) | 555 g (1.22 lb.) | 768 g (1.5 lb.) | 1,436 g (3.16 lb.) | 10.3 kg (22.7 lb.) |
| Weight in Use (Filled) | 195 g (6.88 oz.) | 653 g ( 1.44 lb.) | 1,009 g (2.0 lb.) | 2,207 g (4.86 lb.) | 19.6 kg (43.2 lb.) |
| Connectors | Female M6 threads | 0.5 in. sanitary flange | 0.5 in. sanitary flange | 0.5 in. sanitary flange | 0.5 in. sanitary flange |
Operating Characteristics
Table 3
Operating characteristics of Mustang Q XT capsules*
| Type of Mustang Q XT Capsule |
5 mL Scale Down (P/N XT5MSTGQPM6) |
50 mL Scale Up (P/N XT50MSTGQP05) |
140 mL Pilot Scale (P/N XT140MSTGQP05) |
450 mL Process (P/N XT450MSTGQP05) |
5 L Process (P/N XT5000MSTGQP1) |
| Maximum Operating Temperature | 38 °C | ||||
| Maximum Operating Pressure | 5 bar (72.5 psi) at 38 °C |
3 bar (43.5 psi) at 38 °C |
3 bar (43.5 psi) at 38 °C |
3 bar (43.5 psi) at 38 °C |
3 bar (43.5 psi) at 38 °C |
| Storage Conditions | 0.1 M NaOH + 1 M NaCl | ||||
* With fully compatible fluids that do not soften, swell or adversely affect the capsule or its materials of construction.
Advanced Mustang Membrane Technology
Mustang membrane is a polyethersulfone (PES)-based membrane with a 0.8 μm nominal pore size and a surface coating of an irreversibly cross-linked polymer containing quaternary amine groups. Mustang membrane chromatography allows rapid and direct access to the membrane binding sites for large biomolecules (nucleic acids and proteins) and virus particles by direct fluid convection.
Figure 2
16 layers of Mustang Q membrane in Ultipleat™ structure is adopted consistently across all sizes 
Capsule Design
Mustang Q XT capsules are available in multiple scalable sizes from 5 mL to 5 L volumes and are constructed with 16 layers of Pall’s Mustang Q membrane for consistent performance. Set-up is simple, and each device is 100% integrity tested before shipment for additional quality assurance. If required, process capacities can be increased by linking units in parallel or series.
The durable polypropylene housings have been designed to minimize upstream and downstream hold-up volume, enhancing chromatographic performance (Table 4). The housings provide the chemical stability needed for cleaning, reuse and long-term storage, allowing sanitization and storage in 0.1 M NaOH / 1 M NaCl for up to 12 months.
Seamless Scalability
Scalability is ensured via the consistent use of 16 layers of membrane across all of the product sizes. By maintaining a constant membrane bed height chromatographic performance is maintained across the product range. Scalable Mustang Q XT products meet processing requirements in a range of volumes:
- Screening and pre-clinical: Mustang Q membrane in XT Acrodisc unit (0.86 mL) and Mustang Q XT5 capsule (5 mL)
- Laboratory scale process development work and small-scale clinical manufacturing runs: Mustang Q XT50 (50 mL) and XT140 (140 mL) capsules
- Process scale clinical manufacturing: Mustang Q XT450 (450 mL) and XT5000 (5 L) process scale capsules
Table 4
Hold-up volume comparison across sizes
| Mustang Q Capsule Type | Bed Volume (mL) (A) | Void volume* (mL) (B) | Ratio A/B | EFSA** (cm²) |
| XT5 | 5 | 8 | 1.60 | 22 |
| XT50 | 50 | 98 | 1.97 | 236 |
| XT140 | 140 | 260 | 1.86 | 660 |
| XT450 | 450 | 770 | 1.71 | 2,121 |
| XT5000 | 5000 | 9,200 | 1.84 | 22,000 |
* Total liquid capsule fill volume including pores ( mL)
** Effective functional surface area
Applications
Proven Applications
Mustang Q XT 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:
- Capture of lentiviruses,
- Plasmid purification
- Adeno-associated virus (AAV) and adenoviruses purification
- Purification of large protein
- Monoclonal antibody polishing
In capture applications where the target molecule is relatively large, Mustang membrane exhibits improved capacities and recoveries and higher flow rates compared to packed bed sorbents. Each Mustang Q XT capsule is engineered with a uniform flow path and very low total volume-to-membrane volume ratio, enabling good resolution with high yields and minimal elution volumes.
Application Examples
Capture and Recovery of Plasmid DNA (7 kb) from E. coli Lysate
Table 6
Efficient recovery of plasmid DNA from clarified lysate with Mustang Q XT140 capsule
| Mustang XT140 Fraction (7kb) | Total Volume(L) | pDNA(g/L) | Endotoxin(EU/mg) | Total pDNA(g) | Yield(%) |
| Filtered lysate | 36.80 | 0.10 | * | 3.68 | – |
| Mustang Q XT pDNA pool | 3.33 | 0.89 | 204 | 2.96 | 80 |
Loading conductivity 89.6 mS/cm following alkaline lysis loaded in two cycles at 10 MV/min flow rate
* Not measured, but refer to typical endotoxin levels from E. coli lysate 2.1 x 106 (S. Zhang, A. Krivosheyeva and S. Nochumson. Biotechnol. Appl. Biochem. [2003] 37, 245-249.)
Data courtesy of A. Carnes, Nature Technology, Wilbio Conference, November 2008.
Viral Vector Purification
Mustang Q XT5 capsule provides efficient full capsid enrichment applying optimized step gradient elution.
Figure 3
Differentiation of empty/full vectors achieved with Mustang Q XT5 capsule (1 mS/cm step elution approach)
Type
Use
Related Documents
- Application Note Full Adeno Associated Virus (AAV) Capsid Enrichment Using Mustang® Q Membrane
- 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”
- Poster: Anion Exchange Chromatography Membrane for Full Adeno-Associated Virus (AAV) Capsid Enrichment
- Product Note: Mustang® Q Membrane Chromatography
Regulatory/Quality Documentation
Ordering Information
| Part Number | Description | Quantity |
| XT5000MSTGQP1 | Mustang Q XT5000, Q chemistry with 5 L membrane volume for clinical manufacturing | 1/pkg |
| XT450MSTGQP05 | Mustang Q XT 450 mL membrane volume for clinical manufacturing | 1/pkg |
| XT140MSTGQP05 | Mustang Q XT 140 mL membrane volume for pilot scale process development | 1/pkg |
| XT50MSTGQP05 | Mustang Q XT 50 mL membrane volume for pilot scale process development | 1/pkg |
| XT5MSTGQPM6 | Mustang Q XT 5 mL membrane volume for scale-down process development* | 1/pkg |
| MSTGXT25Q16 | Mustang Q membrane in XT Acrodisc unit (0.86 mL) | 4/pkg |
* The capsule inlet and outlet have female M6 threads and include connectors and tubing
Mustang XT5000 capsules can be connected to increase total available process volume up to 3 capsules using the Mustang XT5000 stand
Mustang XT5000 Stand
| Part Number | Description | Quantity |
| XT5000B100 | Stand base unit (lower section) | 1/pkg |
| XT5000T100 | Top (upper) section | 1/pkg |
| XT5000H100 | Lifting handle | 1/pkg |
Please contact your Pall representative for more information on the XT5000 capsules stand, and other other cartridges and configurations.
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