Mustang® Q XT Chromatography Capsules product photo Primary L

Mustang® Q XT Chromatography Capsules

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.

Figure 1
Preliminary evaluation of membrane performances executed with Acrodisc units (0.86 mL - Left) and scaled up with Mustang XT5 device (5 mL - Right)

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


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Mustang Q XT140 (140ml) capsule product photo
Product ID
XT140MSTGQP05
Membrane Material
PES
Unit of Measure
EA
Min Order Qty
1
Membrane Material
Polyethersulfone (PES)
Unit of Measure
EA
Min Order Qty
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Mustang Q XT5 (5ml) capsule product photo
Product ID
XT5MSTGQPM6
Membrane Material
PES
Unit of Measure
EA
Min Order Qty
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Documents

Datasheets

Download: English

Description

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.

Figure 1
Preliminary evaluation of membrane performances executed with Acrodisc units (0.86 mL - Left) and scaled up with Mustang XT5 device (5 mL - Right)

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

Table 5
BSA dynamic binding capacity at 10 MV/min, demonstrating linear scalability

 
Mustang Q Device Membrane Volume (mL) Breakthrough (mg/mL) Pressure Drop (bar [psi])*
XT Acrodisc unit 0.86 83 ± 6 0.35 [5]
XT5 5 85 ± 5 0.68 [10]
XT50 50 82 ± 15 0.41 [6]
XT140 140 69 ± 10 0.48 [7]
XT450 450 87 ± 3 0.55 [8]
XT5000 5000 75 ± 3 0.62 [9]
 
* Measured at 10 MV/min with Tris buffer

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

Chromatography Capsules

Use

Chromatography

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.