Scale up quickly and reliably with TFF Pelicon cassettes
1
Scale-Up Quickly and Reliably With Pellicon ® Tangential Flow Filtration Cassettes and Hardware Introduction Tangential Flow Filtration (TFF) is a separation process that uses membranes to separate components in a liquid solution or suspension on the basis of size or molecular weight differences. Pellicon ® cassettes combine the advantages of efficient, gentle processing, and linear scalability for effective, predictable scale-up from laboratory to process applications. Whether you are clarifying, concentrating, or purifying milliliters or thousands of liters of solution, you can have confidence in the Pellicon ® product family of TFF cassettes to take you from bench-top to process volumes with predictable, scalable results. The rugged design and chemical compatibility of Pellicon ® cassettes makes it the most reliable and best performing ultrafiltration system available. The Pellicon ® cassette technology is available in a range of surface areas, for process development to purifying large volumes in pilot or manufacturing scale. The membranes and feed channels stay the same, ensuring an easy-to-use, scale-up or scale-down transition from one surface area to the next. Conclusion The devices met or exceeded the acceptance criteria for comparability and scalability in the following areas: Pellicon ® 3 devices demonstrated similar performance despite containing different lots of membrane. With Pellicon ® cassettes and hardware you can achieve: Pellicon ® 3 cassettes: mab & recombinant protein, plasma Ultracel ® PLC membrane: 10, 30 kD Biomax ® membrane: 10, 30, 50 kD Pellicon ® 2 cassettes: All applications Ultracel ® PLC membrane: 5, 10, 30, 100, 300, 1000 kD Biomax ® membrane: 5, 8, 10, 30, 50, 100, 300, 500, 1000 kD Durapore ® membrane: 0,1 0,22 0,45 0,65 um Holder Family A complete range of holders from pre-clinical up to full-scale manufacturing – Stand alone or for integration into a system TFF System Family A complete range of easy-to-use, linearly scalable TFF systems 0.5 to 30 m 2 0.1 to 1.5 m 2 50 to 264 cm 2 50 cm 2 Cogent ® Process-Scale System Mobius ® FlexReady Solution for TFF Cogent ® M1 System Cogent ® μScale System • More cost-effective feedstream • Increase the speed to market by reducing scale-up testing • Easier, more reliable scale-up and scale-down • Higher product recovery • Higher flux • Higher yields • Faster and gentler processing • Greater robustness Because of their reputation for performance and reliability, Pellicon ® cassettes with membranes have been utilized in almost every plasma, vaccine and biotech protein production process in the world. PRE-CLINICAL PRE-CLINICAL PHASE 2 PHASE 2 PHASE 3 PHASE 3 MARKETING APPROVAL PHASE 1 PHASE 1 88 to 264 cm 2 0.1 to 5 m 2 5 to 140 m 2 Pellicon ® 2 Mini 0.1 m 2 Pellicon ® 2 Maxi 2.5 m 2 Pellicon ® 2 0.5 m 2 300 ML – 100 L 2 L AND UP 10 L AND UP Pellicon ® 3 88 cm 2 Pellicon ® 3 0.11 m 2 Pellicon ® 3 0.57 m 2 Pellicon ® 3 1.14 m 2 PILOT / PRODUCTION SCALE-UP / SCALE-DOWN Pellicon ® Cassettes The ideal solution for your Tangential Flow Ultra & Micro Filtration applications 0.0 0.0 10.0 20.0 40.0 20.0 60.0 80.0 TMP (psi) Flux (lmh) 40.0 100.0 30.0 50.0 120.0 cassette 0.57m² cassette 88cm cassette 0.11m² cassette 1.14m² 140.0 160.0 60.0 80.0 70.0 90.0 average +/-10% average Protein Process Performance in Scalability The Pellicon ® lines of Ultracel ® TFF cassettes are used in a variety of applications within the biopharmaceutical industry. Devices containing 10kD PLCGC membrane were selected as representative of the product family. These devices were challenged with a model protein stream to compare the performance of the Pellicon ® 3 minis as well as scalability within the Pellicon ® 3 line. The Pellicon ® 3 cassettes met the specifications for equivalency in terms of protein flux performance. The average limiting flux of the Pellicon ® 88 cm 2 cassette fell within 10%. Pellicon ® cassettes’ true linear scalability allows for faster, but gentler processing of proteins. This results in higher product yields and a more cost-effective solution for your purification and separation needs. Figure 1: Average flux performance Pellicon ® 3 cassettes with 40 g/L BSA The life science business of Merck operates as MilliporeSigma in the U.S. and Canada. Copyright © 2017 Merck KGaA. All Rights Reserved. Merck, Millipore and the Vibrant M are trademarks of Merck. Pellicon, Ultracel, Biomax Durapore, Mobius and Cogent are registered trademarks of Merck. Lit. No. PS2299EN00 Ver. 2.0 | 2017 - 03030 | 03/2017 Frédéric SENGLER, Karine PERON, Millipore S.A.S. 2017 - 03030 - PS2299EN00 Scale up quickly and Reliably_V3.indd 1 3/27/17 9:19 AM
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Transcript of Scale up quickly and reliably with TFF Pelicon cassettes
Scale-Up Quickly and ReliablyWith Pellicon® Tangential Flow Filtration Cassettes and Hardware
IntroductionTangential Flow Filtration (TFF) is a separation process that uses membranes to separate components in a liquid solution or suspension on the basis of size or molecular weight differences.
Pellicon® cassettes combine the advantages of efficient, gentle processing, and linear scalability for effective, predictable scale-up from laboratory to process applications.Whether you are clarifying, concentrating, or purifying milliliters or thousands of liters of solution, you can have confidence in the Pellicon® product family of TFF cassettes to take you from bench-top to process volumes with predictable, scalable results.The rugged design and chemical compatibility of Pellicon® cassettes makes it the most reliable and best performing ultrafiltration system available.The Pellicon® cassette technology is available in a range of surface areas, for process development to purifying large volumes in pilot or manufacturing scale. The membranes and feed channels stay the same, ensuring an easy-to-use, scale-up or scale-down transition from one surface area to the next.
ConclusionThe devices met or exceeded the acceptance criteria for comparability and scalability in the following areas:Pellicon® 3 devices demonstrated similar performance despite containing different lots of membrane.
With Pellicon® cassettes and hardware you can achieve:
Pellicon® 3 cassettes: mab & recombinant protein, plasmaUltracel® PLC membrane: 10, 30 kDBiomax® membrane: 10, 30, 50 kD
Pellicon® 2 cassettes: All applicationsUltracel® PLC membrane: 5, 10, 30, 100, 300, 1000 kDBiomax® membrane: 5, 8, 10, 30, 50, 100, 300, 500,
1000 kDDurapore® membrane: 0,1 0,22 0,45 0,65 um
Holder FamilyA complete range of holders from pre-clinical up to full-scale manufacturing – Stand alone or for integration into a system
TFF System FamilyA complete range of easy-to-use, linearly scalable TFF systems
0.5 to 30 m20.1 to 1.5 m250 to 264 cm250 cm2
Cogent® Process-Scale
System
Mobius® FlexReady
Solution for TFFCogent® M1 System
Cogent® μScale System• More cost-effective feedstream
• Increase the speed to market by reducing scale-up testing• Easier, more reliable scale-up and scale-down• Higher product recovery
• Higher flux• Higher yields• Faster and gentler processing• Greater robustness
Because of their reputation for performance and reliability, Pellicon® cassettes with membranes have been utilized in almost every plasma, vaccine and biotech protein production process in the world.
PRE-CLINICAL
PRE-CLINICAL
PHASE 2
PHASE 2
PHASE 3
PHASE 3
MARKETING APPROVALPHASE 1
PHASE 1
88 to 264 cm2 0.1 to 5 m2 5 to 140 m2
Pellicon® 2 Mini 0.1 m2 Pellicon® 2 Maxi 2.5 m2Pellicon® 2 0.5 m2
300 ML – 100 L 2 L AND UP 10 L AND UP
Pellicon® 3 88 cm2 Pellicon® 3 0.11 m2 Pellicon® 3 0.57 m2 Pellicon® 3 1.14 m2
PILOT / PRODUCTIONSCALE-UP / SCALE-DOWN
Pellicon® CassettesThe ideal solution for your Tangential Flow Ultra & Micro Filtration applications
0.00.0 10.0 20.0 40.0
20.0
60.0
80.0
TMP (psi)
Flux
(lm
h)
40.0
100.0
30.0 50.0
120.0
cassette 0.57m²cassette 88cmcassette 0.11m² cassette 1.14m²
140.0
160.0
60.0 80.070.0 90.0
average +/-10%average
Protein Process Performance in ScalabilityThe Pellicon® lines of Ultracel® TFF cassettes are used in a variety of applications within the biopharmaceutical industry. Devices containing 10kD PLCGC membrane were selected as representative of the product family. These devices were challenged with a model protein stream to compare the performance of the Pellicon® 3 minis as well as scalability within the Pellicon® 3 line.
The Pellicon® 3 cassettes met the specifications for equivalency in terms of protein flux performance. The average limiting flux of the Pellicon® 88 cm2 cassette fell within 10%.Pellicon® cassettes’ true linear scalability allows for faster, but gentler processing of proteins. This results in higher product yields and a more cost-effective solution for your purification and separation needs.
Figure 1: Average flux performance Pellicon® 3 cassettes with 40 g/L BSA
The life science business of Merck operates as MilliporeSigma in the U.S. and Canada.
Copyright © 2017 Merck KGaA. All Rights Reserved. Merck, Millipore and the Vibrant M are trademarks of Merck. Pellicon, Ultracel, Biomax Durapore, Mobius and Cogent are registered trademarks of Merck. Lit. No. PS2299EN00 Ver. 2.0 | 2017 - 03030 | 03/2017
Frédéric SENGLER, Karine PERON, Millipore S.A.S.
2017 - 03030 - PS2299EN00 Scale up quickly and Reliably_V3.indd 1 3/27/17 9:19 AM
