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3M Emphaze
™ ™
AEX Hybrid Purifier
3M Innovation. Transform and Redefine.
Efficiency. Purity. Economics.
Transforming
Ideas
into Realities.
2
3M™ Emphaze™
AEX Hybrid Purifier
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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
Anion Exchange
Significant polymer chemistry development to
Anion Exchange
5
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
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.
6
3M™ Emphaze™
AEX Hybrid Purifier
Cation Exchange
Anion Exchange
LifeASSURE™ PDA010
Series Sterile Capsule
Total
>3 log HCP reduction
>6 log DNA reduction
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)
8
3M™ Emphaze™
AEX Hybrid Purifier
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 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
11
3M™ Emphaze™
AEX Hybrid Purifier
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