Emphaze™ AEX Hybrid Purifer can optimize the purification process of mammalian cell culture products and downstream monoclonal antibodies (mAbs) by protecting Protein A affinity chromatography column and prolonging its service life.
Characteristics of Emphaze™ AEX Hybrid Purifer:
1. Improve process efficiency
lRemove multiple types of impurities through a one-step process, thereby greatly streamlining the customer’s process and achieving better process benefits.
Zeta Plus™ Series Depth Filter, Emphaze™ AEX Hybrid Purifer and LifeASSURE™ Membrane as matching filtration solutions can replace centrifugal unit operation and reduce the used area of downstream sterilizing membrane.
2. Improve product purity and yield
The matching filtration solution provided by 3M can remove impurity particles early in the process, protect the chromatography column and improve its purification performance.
3. Simplify the production process
Emphaze™ AEX Hybrid Purifer is a fully synthetic, high loading purification product consisting of Q-functional nonwoven media and bioburden reducing membrane.
Only buffer or salt solution is recommended for Emphaze™ AEX Hybrid Purifer preconditioning flush, not deionized water.
Process Advantage of Emphaze™ AEX Hybrid Purifer
Turbidity reduction
Based on the Emphaze™ AEX Hybrid Purifer products have strong anion exchange ability and mixing mechanism of 0.2μm membrane at the terminal, so its turbidity reduction ability is better than that of the conventional; depth filtration. During the whole purification process, the turbidity of the filtrate is generally <5NTU.
Figure 1: Pressure-Load and Turbidity-Load curves during the purification process of CHO centrifugate
HCP reduction
The positive charge of the Q-functional nonwoven media bonded to Emphaze™ AEX Hybrid Purifer can significantly reduce the negatively charged HCP. The HCP removal rate of harvest and centrifugate can usually reach 20-40%.
Figure 3: Pressure-Load and HCP removal rate-Load curves during the purification process of CHO centrifugate
DNA reduction
Compared with conventional depth filtration, Emphaze™ AEX Hybrid Purifer has much higher DNA capture ability. Usually, the DNA LVR＞4 in harvest and centrifugate supernatant.
Figure 2: Pressure-Load and DNA removal rate-Load curves during the purification process of CHO centrifugate
Bioburden reduction
The unique design of integrate the Emphaze™ AEX Hybrid Purifer with 0.2μm membrane can provide bioburden LRV＞6, and provide excellent protection for downstream sterilizing membranes (including 0.1μm sterilizing membranes for reducing mycoplasma). This is also an economical strategy to reduce the risk of downstream pollution caused by bacteria and mycoplasma.
Table 1: Challenge test results of defective pseudomonas
Challenge condition 1: Mother liquor of challenger bacteria diluted with physiological saline, 2L (ASTM F838-05)
Challenge condition 2: Undiluted challenge bacteria mother liquor, 6L.
Excellent throughput and mAb recovery
Emphaze™ AEX Hybrid Purifer can not only substantially reduce turbidity, DNA, HCP and bioburden, but also have the same throughput as conventional high-precision depth filter (see Figure 1-3). In addition, as an all-synthetic, low nonspecific binding and positively charged Q-functional nonwoven media purification product, it can provide better mAbs yield than depth filtration.
Improving the performance of capture column
Emphaze™ AEX Hybrid Purifer can effectively reduce pre Protein A Column soluble impurities, such as DNA and HCP, thus greatly improving the performance of the capture column. That is, after using Emphaze™ AEX Hybrid Purifer in the upstream purification process, the capture column can remove HCP and DNA more effectively.
Enhance the protection to capture column
Emphaze™ AEX Hybrid Purifer has excellent protection ability against expensive capture chromatography, and greatly reduces the impurities bound to chromatography column. So, a milder column cleaning condition can be adopted, which can greatly prolong the service life of the chromatography column.
Application of Cell Harvest & Clarification
Emphaze™ AEX Hybrid Purifer, combined with Zeta Plus™ Series Depth Filter and LifeASSURE™ membrane as a matching filtration solution, can greatly improve the process and make it possible to operate without centrifugation.
• HCP remove rate is 30%, DNA LRV >4
• Consistent output turbidity <5 NTU
• Output particle size distribution <30nm
• Bioburden LRV >6
Application of Capture, Fine Purification, and Final Filling
The performance of Emphaze™ AEX Hybrid Purifer can reduce the use scale of fine chromatography columns for subsequent removal of soluble impurities such as DNA, HCP and viruses. 3M Emphaze™ AEX Hybrid Purifer greatly improved the whole production efficiency by significantly reducing the soluble impurities such as DNA and HCP in the samples on the capture column.
Emphaze™ AEX Product Selection/Specification
Guochu Technology (Xiamen) provides products of 3M, including: Harvest RC Series Filter, Emphaze™ AEX Series Chromatography Filter, Polisher ST Series Chromatography Filter, LifeASSURE™ PDA Filter Cartridge, LifeASSURE™ PFS Filter Cartridge, LifeASSURE™ BDA Filter Cartridge, Zeta Plus™ Filter Cartridge, LifeASSURE™ BA Series Filter Cartridge, LifeASSURE™ BNA Filter Cartridge, BetafineT™ DP Filter Cartridge, BetafineT™ XL Filter Cartridge, BetafineT™ BT Filter Cartridge, Micro-Klean™ RT Filter Cartridge, Micro-Klean™ D Filter Cartridge, Betapure™ AU Filter Capsule, Betapure™ NT-T Filter Capsule, 3M™ High Flow Filter Cartridge, 3M™ NB Filter Bag, Micro Screen™ Metal Filter Cartridge, Liqui-Cel™ Membrane Contactor, Liqui Flux™ B Cross-flow Membrane, 3M™ CFSI Activated Carbon Filter Cartridge, ZW Series Cartridge, Zeta Plus™ Series Cartridge, Sanitary High Flow Cartridge, etc.
For details, please contact +86-592-6518670, +86-592-6514970.
Guochu Technology (Xiamen) provides all models of 3M Emphaze™AEX Hybrid Purifer Series, including: EMP301AEX020A, EMP303AEX020A, EMP513AEX020A, EMP710AEX020A, EMP770AEX020A.
