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3M Purification

Single-Use Clarification and Purification for Biopharmaceutical Processes

3M Emphaze
™ ™
AEX Hybrid Purifier
3M Innovation. Transform and Redefine.
Efficiency. Purity. Economics.

The 3M™ Emphaze™ platform represents a new class of


purification products that can redefine the manufacturing
processes for the production of therapeutic proteins and
other biologics.
3M Innovation: 3M Advancing the
Making Progress Possible Biopharmaceutical Industry
3M creates transformational products and solutions At 3M, we are advancing the global pharmaceutical
that enable customer successes and improve people’s industry by helping to build products that enable
lives around the world. better and more efficient manufacturing processes.
We utilise a collaborative, high-energy approach to 3M Purification provides cutting-edge technologies
solve the toughest problems across industries and to address filtration and purification needs of the
markets by: global biopharmaceutical industry.
• Constantly exchanging and building on each We deliver novel products to enable reduction in the
other’s ideas. complexity and cost of pharmaceutical, vaccines and
• Uncovering new connections between plasma fractionation production processes.
seemingly unrelated markets and more than
50 diverse technology platforms.
• Fostering a culture of intellectual curiosity and
creativity that pushes boundaries.

Transforming
Ideas
into Realities.
2
3M™ Emphaze™
AEX Hybrid Purifier

“The 3M™ Emphaze™ AEX Hybrid Purifier combines


advanced polymer materials, a novel anion exchange
hydrogel nonwoven media integrated with a fine
particle, bioburden reduction multi-zone membrane.”

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Unique 3M Technology
The 3M Emphaze AEX Hybrid Purifier is created using the unique combination of numerous 3M proprietary
technologies. The resulting product provides an extremely high level of product protein purity early in the
downstream process.
The 3M Emphaze product platform demonstrates that 3M’s materials-based technology engine enables true
innovation for the Biopharmaceutical industry. The 3M Emphaze AEX Hybrid Purifier combines advanced
polymer materials, a novel anion exchange hydrogel nonwoven media integrated with a fine particle, bioburden
reduction multi-zone membrane.

3
Transforming the Biopharmaceutical Making Your Job Easier
Production Process: Increased Process Efficiencies
• Simplifying our customers’ processes by
removing multiple types of impurities in a
Efficiency. Purity. Economics. single process step, leading to a better process
economics.
• As a matched component solution, 3M’s Zeta Plus
Series depth filter, Emphaze AEX Hybrid Purifier
and LifeASSURE membrane filters can eliminate
the need for the centrifuge unit operation and
The 3M™ Emphaze™ AEX Hybrid Purifier also reduce the required area of the downstream
represents a new class of clarifying products that sterilising-grade membrane.
can be applied to redefine your manufacturing Increased Product Purity and Yield
processes for the production of therapeutic proteins • Removing impurities early in the process, the 3M
like monoclonal antibodies (mAb), blood proteins and matched component solution provides protection
vaccines. to chromatography columns increasing their
3M Emphaze AEX Hybrid Purifier, the first in a series purification performance.
of chromatography and membrane chromatographic Simplified Manufacturing Process
products, is designed to remove insoluble and soluble • Elimination or optimisation of unit operations
impurities, like cell debris, aggregates, bacteria, DNA, results in significant manufacturing operational
HCP and virus, which helps optimise downstream efficiency improvement.
processes. Through a unique combination of 3M
technologies, 3M has created an encapsulated, single- Significant biopharmaceutical process-wide improvements
use all-synthetic clarifying media based on a hydrogel are achieved when deployed at the clarification stage of the
nonwoven media. monoclonal antibody purification:
The 3M Emphaze AEX Hybrid Purifier delivers High
• Nominal 30% HCP and greater than 4 log DNA reduction
• Consistent output turbidity (< 5 NTU)
clarified process fluid by removing insoluble performance
• Tight particle size cut-off (<30 nm)
clarification
impurities, such as cell debris, aggregates and • Greater than 6 log bioburden reduction
bacteria, through a combination of chromatographic • > 10x less HCP in the product stream post Protein A
Enables higher • > 1000x reduction in DNA concentration post Protein A
and size exclusion mechanisms. Protein A column • > 10x less residual contaminants on Protein A column
performance • Reduced column capacity fade and potentially
When used at the clarification stage, the matched extended column life
component combination of 3M Emphaze AEX Enables tighter • Seamless 0,2 μm to 0,1 μm transition
Hybrid Purifier, Zeta Plus™ depth filters and sterilising filters • Significant reduction in filter surface area
LifeASSURE™ membrane filters provide a process with less surface
area
with increased efficiency and protein purity. This can
Enables smaller • > 10x less contaminants
enable the reduction of substantial biopharmaceutical downstream • Target protein at or near regulatory HCP and DNA
manufacturing costs. AEX column contaminate purity requirements

3M Emphaze
AEX Hybrid
4
Purifier
3M™ Emphaze™
AEX Hybrid Purifier

Unique Product. Unique Construction.


The 3M™ Emphaze™ AEX Hybrid Purifier is an integral combination of two types of purification media that
work together to provide high product purity in a single unit operation.
The all-synthetic purification media and unique layering construction provides high purity by integrating
multiple separation mechanisms into one single-use product:

4 layers of Q-functional Nonwoven


Media
Strong anion exchange chromatographic media,
comprised of a hydrogel nonwoven, provides high
removal of insoluble and soluble impurities such as
Layer 1 cell debris, aggregates, bacteria, DNA, HCP and
virus.
Nonwoven Media

Layer 2 Highly Asymmetric 0.2 μm Bioburden


Reduction Filter
Layer 3
The unique combination of a highly asymmetric 9
zone microporous membrane along with the highly
Layer 4 charged hydrogel media provides a substantial
reduction of negatively charged soluble impurities,
including microbiological contaminants.
Each zone and layer of the membrane has a
progressively smaller pore size allowing both
Bioburden Reduction Membrane

high purity and high throughput early in the


downstream process.
Zone 1-3 • Fine particle removal that exceeds the
performance of a 0,2 or 0,1 grade micron
membrane alone.
Zone 4-6
• Superior turbidity (particle) removal: <5 NTU.
Zone 7-9 0,2 μm • > 6 log bioburden reduction.
• Even flow distribution.

Anion Exchange
Significant polymer chemistry development to
Anion Exchange

create a highly-charged, durable polymer for


reduction of negatively charged insoluble and
soluble impurities including cell debris, aggregates,
bacteria, virus, endotoxin, DNA and HCP for
higher purity and increased efficiencies.

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Applications for Cell Culture and Harvest and Clarification
The 3M™ Emphaze™ AEX Hybrid Purifier, • 30% HCP and greater than 4 log DNA reduction.
when used in clarification as a matched component
solution with 3M’s Zeta Plus™ depth filtration • Consistent output turbidity (< 5 NTU).
and LifeASSURE™ sterilising-grade membrane,
enables significant process-wide improvements • Tight particle size cut-off (< 30 nm).
providing opportunity to optimise a centrifuge free
• Greater than 6 log bioburden reduction.
process.

Cell Culture

Master Cell Bank


(MCB)

X
• 3M™ Emphaze™ AEX Hybrid Purifier when
used as a matched component solution
with a Zeta Plus™ filter and LifeASSURE™
membrane may provide a centrifuge-free direct
harvest clarification using a 3-stage clarification
train having sterile effluent.

The 3M™ Emphaze™ AEX Hybrid


Purifier’s built-in 0,2 micron membrane
provides opportunity for reduction of the
sterilisation-grade membrane surface
area and enables the use of 0,1 micron
membrane.
Zeta Plus™ Encapsulated System
• Protects and improves performance
of capture chromatography
3M™ Emphaze™ AEX Purifier
• Outstanding turbidity reduction
• DNA, HCP reduction
• Bioburden reduction
LifeASSURE™ PDA020 (0,2 μm)
LifeASSURE™ PDA010 (0,1 μm)
Series Sterile Capsule
Harvest and Clarification

6
3M™ Emphaze™
AEX Hybrid Purifier

• Increased product purity post Protein A Capture and Polish


• Reduction of column exposure to
difficult-to-clean contaminants
– Less denaturing column cleaning • Purification at the clarification stage significantly
– Reduced column capacity fade impacts processes downstream of the affinity
column
– Improvement: >1 Log HCP, >3 Log DNA
• Enables adoption of membrane adsorber
technology in place of column chromatography

Cation Exchange

Anion Exchange
LifeASSURE™ PDA010
Series Sterile Capsule

Total
>3 log HCP reduction
>6 log DNA reduction

• Reduction in AEX column size


LifeASSURE™ PDA020 (0,2 μm) • Lower capital expense
LifeASSURE™ PDA010 (0,1 μm) • Lower operating expense
Series Sterile Capsule • Enables membrane adsorber
Fill and Finish technology

Applications for Capture and DNA Reduction Enhanced Performance of


> 4 LRV Protein A Column
Polish, Fill and Finish
HCP Reduction Protection and
3M Emphaze AEX Hybrid Purifier performance 20 - 40% Cleanability
allows reduction in the size of polishing columns
which are designed to eliminate residual soluble Bioburden Reduction Excellent mAb Recovery
impurities such as DNA, HCP and virus. By > 6 LRV* of > 95% mAb
significantly reducing the loading of soluble Brevundimonas Diminuta
impurities, such as DNA and HCP onto the capture
chromatography column, 3M Emphaze AEX Turbidity Reduction
Hybrid Purifier substantially enhances the overall < 5 NTU * (LRV) Log Reduction Value
manufacturing process.
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Process Features Host Cell Protein Reduction
Superior Turbidity Reduction The Q-functional nature of the 3M Emphaze AEX
Hybrid Purifier provides superior reduction of
The 3M™ Emphaze™ AEX Hybrid Purifier negatively charged HCP. HCP reduction of 20-40% is
provides better turbidity reduction than conventional often achieved with harvest and centrate fluids.
clarification unit operations, with outlet turbidity
typically < 5 NTU throughout the entirety of the Graph 3: Pressure and HCP reduction, as a function of throughput,
during clarification of a CHO centrate
clarification run, due to the combination of high
anion exchange capacity and 0,2 μm rated membrane. Conventional Clarification
Pool
3M™ Emphaze™ AEX Hybrid Purifier 6% reduction
Graph 1: Pressure and turbidity reduction, as a function of 50%
Pool
throughput, during clarification of a CHO centrate 40% 31% reduction
7,53 NTU

HCP Reduction
8
Conventional Clarification 30%
7
3M™ Emphaze™ AEX Hybrid Purifier
20%
Outlet Turbidity (NTU)

5
10%
4 3,39 NTU

3
0%
Pressure (bar)

2 1,72 bar
Pool 1,38
1 4,19 NTU
0,69
0
Pool 0
2,19 NTU 0 100 200 300 400 500 600 700 800
Pressure (bar)

1,38 1,72 bar Throughput (l/m²)


0,69
0
0 100 200 300 400 500
Throughput (l/m²)
600 700 800
Bioburden Reduction
The unique hybrid design of the 3M Emphaze AEX
DNA Reduction Hybrid Purifier, incorporating a 0,2 μm membrane,
provides greater than a 6 LRV of bioburden and
The 3M Emphaze AEX Hybrid Purifier has a
affords high protection of downstream sterilising
binding capacity for DNA substantially higher than
membranes, including LifeASSURE™ 0,1 μm
conventional depth filters. It generally provides
sterilising membranes for mycoplasma reduction.
greater than a 4 Log Reduction Value (LRV) of DNA
This enables economical strategies to reduce the
from harvest and centrate fluids.
risk of downstream contamination by bacteria and
Graph 2: Pressure and DNA reduction, as a function of throughput, mycoplasma.
during clarification of a CHO centrate
6 Table 1: Results of two B. diminuta Challenges
5 Challenge
Total Challenge Total
Test Volume, Solution
DNA Reduction (LRV)

Challenge, Level, Effluent, LRV


4 Conventional Clarification No. L Concentration,
CFU CFU/cm² CFU
3M™ Emphaze™ AEX Hybrid Purifier Pool CFU/mL
3 4,6 LRV
1 0-2 6,8 x 106 1,4 x 1010 8,2 x 107 1,0 x 102 8,1
2 6 12 9 5
Pool 0-2 5,4 x 10 1,1 x 10 6,5 x 10 1,3 x 10 6,9
1,4 LRV
6 12 10 5
1 2 2-4 5,4 x 10 2,2 x 10 1,3 x 10 4,3 x 10 6,7
0 4-6 5,4 x 106 3,2 x 1012 1,9 x 1010 1,1 x 106 6,5

Challenge 1 = Saline-diluted master culture, 2 L (ASTM F838-05)


Pressure (bar)

1,38 1,72 bar


Challenge 2 = Undiluted master culture, 6 L
0,69
0
0 100 200 300 400 500 600 700 800
Throughput (l/m²)

8
3M™ Emphaze™
AEX Hybrid Purifier

Monoclonal Antibody Enhanced Capture Column Protection


Process Benefits The 3M Emphaze AEX Hybrid Purifier provides high
protection of the valuable capture chromatography column,
Excellent Throughput and mAb resulting in measurably fewer column-bound impurities.
This has the potential to increase capture column life
Recovery through less aggressive column cleaning procedures.
While providing superior reduction of Figure 1: HCP concentrations in CHO harvest or centrate (1), clarified
impurities including turbidity, DNA, HCP fluid (2), protein A eluate (3) and clean-in-place fluid (4) when
and bioburden, the 3M Emphaze AEX CHO harvest/centrate was clarified using either conventional
Hybrid Purifier generally exhibits throughput clarification (blue) or Emphaze™ AEX Hybrid Purifier (orange).
performance similar to the best commercially Harvest/ Clarified
Protein A
Protein A
4M Guanidine HCI
CIP
available fine conventional depth filters (see Centrate Clarification Fluid Chromatography Eluate Clean-In-Place Fluid
. 3 $ /
graphs 1-3). Also, the cationic nature of Set-up 1, Conventional Clarification
the Q-functional nonwoven and very low 1 000 000
Set-up 1, 3M™ Emphaze™ AEX Hybrid Purifier
Set-up 2, Conventional Clarification
nonspecific binding of the all-synthetic hybrid 100 000
24% reduction Set-up 2, 3M™ Emphaze™ AEX Hybrid Purifier

media provide excellent mAb recovery, 34% reduction 15 982


19X
ppm HCP/IgG

typically exceeding the very good mAb 10 000 19X 3 056


859 634
recovery achieved by conventional depth filters. 1 000
78X 17X
100 78X
39 37

Enhanced Capture Column 10

1
Performance Harvest/Centrate
.
Clarified Fluid
3
Protein A Eluate
$
CIP Fluid
/

By significantly reducing the loading of Figure 2: DNA concentrations in CHO centrate (1), clarified fluid (2), protein
soluble impurities, such as DNA and HCP, A eluate (3) and acid regeneration fluid (4) when CHO centrate
onto the capture chromatography column, was clarified using either a conventional depth filter (blue) or
the 3M Emphaze AEX Hybrid Purifier Emphaze™ AEX Hybrid Purifier (orange).
can substantially enhance its purification Clarified Protein A Regen.
Protein A- Acid
performance. That is, HCP and DNA reduction Centrate
.
Clarification Fluid
3
Chromatography Eluate
$
Regeneration Fluid
/
by the capture chromatography column may 100 000 000 4,26E+07 4,12E+07 6,17E+07
be significantly improved when the Emphaze
Conventional Clarification
DNA Concentration (pg/ml)

10 000 000 3M™ Emphaze™ AEX Hybrid Purifier


AEX Hybrid Purifier is used for upstream 1 000 000
4,0 log
188 867
clarification process. 100 000
5 592 3,5 log 3 580
10 000
1 000 2,7 log
100 57

10 7,5

1
Centrate Clarified Fluid Protein A Eluate Regen. Fluid
. 3 $ /

Advancing
the Industry 9
Scientific Applications Support Scientific Services
Services (SASS) Post-use Integrity Test Adsorption
• Process Fluid • Binding
3M has a global team of market-focused • Correlation - Equilibrium
scientists and engineers who excel in supporting, - Recovery
Bacterial Challenge Test
collaborative efforts between our customers and • ASTM Extractables and Leachables
3M. - Brevundimonas Dimunuta • Flush-up Studies
Our technical team is skilled in performing on- ATCC 19146 • Recirculation Studies
site bench-scale tests and relating the results to - Acholoeplasma laidlawii • United States
full-scale manufacturing process operations. ATCC 23206 Pharmacopoeial (USP)
- Microbiological Tests (61,
When unique processing problems are Compatibility 62, 63, 71)
encountered, our expert product and application • Sterilisation - Biological Tests (85, 87, 88)
specialists are equipped to identify solutions • Solvents - Chemical Tests (231, 233,
using 3M’s broad array of existing products and • Integrity others as required)
solutions. • Viability - Physical Tests (631, 643,
645, 661, 787, 788, 790,
791)
• GMP Guidelines
• Flushing

Antwerp, Belgium
St. Paul, MN, USA
Tokyo, Japan

Shanghai, China
Sumaré, Brazil

Cairo, Egypt
3M Validation
Laboratory
Bangalore, India 3M Technical
Specialist
3M Corporate
Research Laboratory
3M Purification provides comprehensive technical services and advanced engineering
support for biopharmaceutical customers from centres around the world.

Global
Support
10
Network
3M™ Emphaze™
AEX Hybrid Purifier

Product Selection/Specification
Product Name BV8 BV60 BV120 BV360 BV800 BV5600
Model Number EMP301AEX020A EMP303AEX020A EMP503AEX020A EMP513AEX020A EMP533AEX020A EMP710AEX020A EMP770AEX020A
Part Number 70020301647 70020301654 70020301662 70020301670 70020301688 70020301696 70020301704
Global Part
7100037396 7100037383 7100029619 7100029617 7100029616 7100048383 7100048384
Number
Height x Diameter 4,5 cm x 7,7 cm 8,8 cm x 7,7 cm 10,3 cm x 21,6 cm 15,2 cm x 21,6 cm 5,7 cm x 45,2 cm 20,3 cm x 45,2 cm
Weight Dry 71 g 77 g 1,0 kg 1,0 kg 1,4 kg 3,1 kg 9,2 kg
Weight Wet Post
80 g 85 g 1,1 kg 1,1 kg 1,9 kg 3,8 kg 13,9 kg
Blow Down
Fill Volume1 13 ml 16 ml 550 ml 550 ml 1,4 l 3,4 l 10,6 l
Hold Up Volume
9 ml 100 ml 150 ml 460 ml 700 ml 4700 ml
Post Blow Down2
Polypropylene, Polysulfone, Polypropylene, Polycarbonate, Polypropylene,
Capsule Material
Glass-filled Polypropylene Thermoplastic Elastomer, Fluorocarbon Thermoplastic Elastomer, Silicone
Sterilisation Post
Post use 1 autoclave cycle at 121 ºC for 30 minutes Post use 1 autoclave cycle at 126 ºC for 30 minutes
Use
Inlet/Outlet
Luer Fitting ½” or ¾” Sanitary Connector 1 ½” Sanitary Connector (manifold)
Connections
Max. Inlet
2,8 bar 3,1 bar 3,4 bar
Pressure3
Max. Differential
2,4 bar
Pressure
Max. Temperature 40 ºC
Required
Preconditioning 0,13 l 0,9 l 1,8 l 5,5 l 12 l 85 l
Flush Volume4
Recommended Use
8 ml/min 50 ml/min 100 ml/min 300 ml/min 700 ml/min 4900 ml/min
Flow Rate
Storage Conditions Controlled Indoor Temperatures: 0 - 30 °C in original sealed packaging
Shelf-life5 Up to 2 years from date of manufacture at maximum 30 °C

Do not sterilise or sanitise pre-use


1 Capsule Fill Volume is defined as the volume of liquid that is required to fill the capsule.
2 Post Blow Down Hold Up Volume is defined as the volume of the residual liquid after air/gas blow down.
3 Do not use this product for continuous service with compressed gasses. The use of compressed gas is permissible for integrity testing and blow down purposes.
4 The Preconditioning Flush is required for the product to be compliant with USP Biological Reactivity Tests including USP36 <87> and <88> Class VI. The flush solution can be a buffer
or 25-150 mM sodium chloride solution.
5 3M™ Emphaze™ AEX Hybrid Purifiers are designed to maintain USP <88> Class VI compliance and high adsorption capacity for up to 2 years from date of manufacture. Product
labeling includes the expiration date.
A full support package is available for 3M™ Emphaze™ AEX Hybrid Purifiers.
This package includes Installation and Operation Guides, Certificate of Quality and a Regulatory Support File.

Hardware and Single-Use Manifold Ordering Information


Model Name Description Part Number Global Part Number

01EZA Stainless Steel Holder 1 BV5600 capsule 70020310804 7100024303

03EZA Stainless Steel Holder up to 3 BV5600 capsules 70020310838 7100024304

07EZB Stainless Steel Holder up to 7 BV5600 capsules 70020274455 7000051418


Top and Bottom Manifold
Manifold Set 70020256221 7000001850
for use with BV800 and BV5600
Please contact your local representative for further information.

11
3M™ Emphaze™
AEX Hybrid Purifier

Product Scaling Configurations

rs x >2
CAPACITY

p Facto
-U Multi-Round
Scale x7 to
x49 Production
x2.3 to Large Scale
x15,6 Production
x3 or Pilot
x6 Production
x7 or
x14
Scale-Up
p 2 000 - 25 000 L
200 - 2 500 L
Lab/
R&D 25 - 200 L
5 - 25 L
1-5L Production Scale Products
0,5 - 1 L
PROCESS VOLUME

Important Notice
The information described in this literature is accurate to the best of our knowledge. A variety of factors, however, can affect the performance of the Product(s) in a particular application, some
of which are uniquely within your knowledge and control. INFORMATION IS SUPPLIED UPON THE CONDITION THAT THE PERSONS RECEIVING THE SAME WILL MAKE THEIR OWN DETERMINATION
AS TO ITS SUITABILITY FOR THEIR USE. IN NO EVENT WILL 3M PURIFICATION BE RESPONSIBLE FOR DAMAGES OF ANY NATURE WHATSOEVER RESULTING FROM THE USE OF OR RELIANCE UPON
INFORMATION.
It is your responsibility to determine if additional testing or information is required and if this product is fit for a particular purpose and suitable in your specific application.
3M PURIFICATION MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR OF ANY OTHER NATURE HEREUNDER WITH RESPECT TO INFORMATION OR THE PRODUCT TO WHICH INFORMATION REFERS.
Limitation of Liability
3M Purification will not be liable for any loss or damage arising from the use of the Product(s), whether direct, indirect, special, incidental, or consequential, regardless of the legal theory asserted,
including warranty, contract, negligence or strict liability. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to you.

3M, Emphaze, Zeta Plus and LifeASSURE are registered trademarks of the 3M Company.
3M Belgium BVBA/SPRL - 3M Purification All other trademarks are the property of their respective owners.
E-mail: 3MPurification.be@mmm.com
Address details: www.3M.be For more products and product applications visit our website at www.3m.be/purification or
www.3m.nl/purification.
3M Nederland BV - 3M Purification
E-mail: 3MPurification.nl@mmm.com Data may be subject to change without further notice. v.3 - DOC10357
Address details: www.3M.nl © 3M 2015. All rights reserved. LITCTEMP1.EU - 0315