3M Emphaze. AEX Hybrid Purifier. 3M Innovation. Transform and Redefi ne. Effi ciency. Purity. Economics. 3M Purification

Transcription

1 3M Purification SingleUse Hybrid Clarifier for Biopharmaceutical Processes 3M Emphaze AEX Hybrid Purifier 3M Innovation. Transform and Redefi ne. Effi ciency. Purity. Economics.

2 3M Emphaze AEX Hybrid Purifi er Designed to optimise clarification of mammalian cell cultures and optimise downstream processes for monoclonal antibodies (mabs) by protecting and increasing the life of protein A column. Efficiency. Reduces the load on chromatography columns with a singleuse product Purity. Provides high fl uid purity as early as possible in the downstream process Provides the expensive protein A column the best possible protection Economics. Helps reduce the total cost of ownership by simplifying the process train. 2 Transform and Redefi ne

3 3M Emphaze AEX Hybrid Purifi er The NEW Emphaze TM AEX Hybrid Purifier is an allsynthetic, multimechanism clarifying device containing both a Qfunctional anion exchange hydrogel media integrated with a fine particle, bioburden reduction membrane. Emphaze AEX Hybrid Purifi er 4 layers of Qfunctional nonwoven media Tilted crosssection of 4 layers of Qfunctional nonwoven Layer 1 Layer 2 Layer 3 Layer 4 Zone 1 Highly asymmetric.2 μm bioburden reduction membrane Zone 4 Zone 9.2 μm (a) PP BMF Fibre (b) PP BMF Fibre Illustrations of the grafted cationic polymer chain conformations in a pore of the Qfunctional nonwoven (a) in deionised water, and (b) in water containing a dissolved salt. 3

4 Process Benefi ts Superior Turbidity Reduction Due to its high anion exchange capacity and its defined.2 μm final pore size, Emphaze AEX Hybrid Purifier provides better turbidity reduction than depth filters, with outlet turbidity typically < 5 NTU throughout the entirety of the clarification run. Graph 1: Pressure and turbidity reduction, as a function of throughput, during clarification of a CHO centrate HCP Reduction The Qfunctional nature of Emphaze AEX Hybrid Purifier provides superior reduction of negatively charged HCP. HCP reduction of 24% is often achieved with harvest and centrate fluids. Graph 3: Pressure and HCP reduction, as a function of throughput, during clarification of a CHO centrate Outlet Turbidity (NTU) Conventional Clarification Emphaze AEX Hybrid Purifier 7.53 NTU 3.39 NTU 4.19 NTU 2.19 NTU DNA Reduction (LRV) Conventional Clarification Emphaze AEX Hybrid Purifier 4.6 LRV 1.4 LRV Pressure (bar) bar Throughput (l/m²) Pressure (bar) bar Throughput (l/m²) DNA Reduction Emphaze AEX Hybrid Purifier has a binding capacity for DNA, substantially higher than conventional depth filters. It generally provides greater than a 4 Log Reduction Value (LRV) of DNA from harvest and centrate fluids. Graph 2: Pressure and DNA reduction, as a function of throughput, during clarification of a CHO centrate Bioburden Reduction The unique hybrid design of the Emphaze AEX Hybrid Purifier, incorporating a.2 μm membrane, provides greater than a 6 LRV of bioburden and affords unsurpassed protection of downstream sterilising membranes, including.1 μm sterilising membranes for mycoplasma reduction. This enables economical strategies to reduce the risk of downstream contamination by bacteria and mycoplasma. HCP Reduction 5% 4% 3% 2% 1% % Conventional Clarification Emphaze AEX Hybrid Purifier 31% reduction 6% reduction Table 1: Results of two B. diminuta Challenges Test No. Volume, L Challenge Solution Concentration, CFU/mL Total Challenge, CFU Challenge Level, CFU/cm² Total Effluent, CFU LRV x x x x x x x x x x x x x x x x Pressure (bar) bar Throughput (l/m²) Challenge 1 = Salinediluted master culture, 2 L (ASTM F8385) Challenge 2 = Undiluted master culture, 6 L 4

5 3M Emphaze AEX Hybrid Purifi er Excellent Throughput and mab Recovery While providing superior reduction of impurities including turbidity, DNA, HCP and bioburden, Emphaze AEX Hybrid Purifier generally exhibits throughput performance similar to the best commercially available fine grades of conventional depth filters (see Graphs 13). Also, the cationic nature of the Qfunctional nonwoven and very low nonspecific binding of the allsynthetic hybrid media provide excellent mab recovery, typically exceeding the very good mab recovery achieved by conventional depth filters. Enhanced Capture Column Performance By significantly reducing the loading of soluble impurities, such as DNA and HCP, onto the capture chromatography column, Emphaze AEX Hybrid Purifier can substantially enhance its purification performance. That is, HCP and DNA reduction by the capture chromatography column may be significantly improved when Emphaze AEX Hybrid Purifier is used for clarification upstream. Enhanced Capture Column Protection Emphaze AEX Hybrid Purifier provides unsurpassed protection of the valuable capture chromatography column, resulting in measurably fewer columnbound impurities. This has the potential to increase capture column life through less aggressive column cleaning procedures. Figure 1: HCP concentrations in CHO harvest or centrate (1), clarified fluid (2), protein A eluate (3) and cleaninplace fluid (4) when CHO harvest/centrate was clarified using either conventional clarification (blue) or Emphaze AEX Hybrid Purifier (orange). Harvest/Centrate Clarification Clarified Fluid Chromatography Protein A Eluate 4M Guanidine HCI CleanInPlace CIP Fluid ppm HCP/IgG % reduction 34% reduction Protein A X 19X X 39 78X X Setup 1, Conventional Clarification Setup 1, Emphaze AEX Hybrid Purifier Setup 2, Conventional Clarification Setup 2, Emphaze AEX Hybrid Purifier 1 Harvest/Centrate Clarified Fluid Protein A Eluate CIP Fluid Figure 2: DNA concentrations in CHO centrate (1), clarified fluid (2), protein A eluate (3) and acid regeneration fluid (4) when CHO centrate was clarified using either a conventional depth filter (blue) or Emphaze AEX Hybrid Purifier (orange). Protein A Centrate Clarification Clarified Fluid Chromatography Protein A Eluate Acid Regeneration Regen. Fluid DNA Concentration (pg/ml) E7 4.12E7 6.17E log Centrate Clarified Fluid Protein A Eluate Regen. Fluid log log Conventional Clarification Emphaze AEX Hybrid Purifier 5

6 Master Cell Bank (MCB) CAPACITY x7 or x14 Lab/ R&D x3 or x6 ScaleUp 1 5 L 5 25 L x2.3 to x15.6 Pilot Production 25 2 L x7 to x49 ScaleUp Factors x >2 Large Scale Production L Production Scale Products Coming in December 214 MultiRound Production 2 25 L.5 1 L PROCESS VOLUME Figure 3: Product Configurations Scaleup: From Benchtop to Pilot Plant to Production LifeASSURE UF/DF 6

7 3M Emphaze AEX Hybrid Purifi er Zeta Plus Encapsulated System Protects and improves performance of capture chromatography Emphaze AEX Hybrid Purifier LifeASSURE Enables use of.1μm sterilising membrane UF/DF LifeASSURE LifeASSURE 7

8 3M Emphaze AEX Hybrid Purifi er Product Selection/Specifi cation Product Name BV8 BV6 BV12 BV36 Model Number EMP31AEX2A EMP33AEX2A EMP53AEX2A EMP513AEX2A EMP533AEX2A Part Number Global Part Number Height x Diameter 4.5 cm x 7.7 cm 8.8 cm x 7.7 cm 1.3 cm x 21.6 cm 15.2 cm x 21.6 cm Weight Dry 71 g 77 g 1. kg 1. kg 1.4 kg Weight Wet Post Blow Down 8 g 85 g 1.1 kg 1.1 kg 1.9 kg Fill Volume 1 13 ml 16 ml 55 ml 55 ml 1.4 l Hold Up Volume Post Blow Down 2 9 ml 1 ml 15 ml 46 ml Capsule Material Polypropylene, Glassfi lled Polypropylene Polysulfone, Polypropylene, Thermoplastic Elastomer, Fluorocarbon Sterilisation Post Use Post use 1 autoclave cycle at 121 ºC for 3 minutes Post use 1 autoclave cycle at 126 ºC for 3 minutes Alkaline Resistance Post Use Resistance based on testing with 1 M NaOH and 5% NaClO (Bleach) Inlet/Outlet Connections Luer Fitting ¾ Sanitary Connector ¾ Sanitary Connectors Max. Inlet Pressure bar 3.1 bar Max. Temperature 4 ºC Required Preconditioning Flush Volume 4.13 l.9 l 1.8 l 5.5 l Recommended Use Flow Rate 8 ml/min 5 ml/min 1 ml/min 3 ml/min Storage Conditions Controlled Indoor Temperatures: 3 C in original sealed packaging Shelflife 5 Up to 2 years from date of manufacture 1 Capsule Fill Volume is defi ned as the volume of liquid that is required to fi ll the capsule. 2 Post Blow Down Hold Up Volume is defi ned 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 fl ush solution can be a buffer or 2515 mm sodium chloride solution. 5 Emphaze AEX Hybrid Purifi ers are designed to maintain USP36 <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 Emphaze AEX Hybrid Purifiers. This package includes Installation and Operation Guides, Certificate of Quality and a Regulatory Support File. 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 fi t for a particular purpose and suitable in your specifi c 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 Purifi cation 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 United Kingdom plc 3M Purification 3M Centre, Cain Road Bracknell, RG12 8HT United Kingdom Tel.: Fax: 44 () purifi cation.uk@mmm.com 3M and Emphaze are registered trademarks of the 3M Company. All other trademarks are the property of their respective owners. For more contact addresses visit our website cation. Data may be subject to change without further notice. 3M 214. All rights reserved. DOC1357 LITCTEMP1.EU 614