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