Cross-flow filtration for discovery, scale-up and process clarification/concentration applications

Transcription

1 biopharmaceutical / bioindustrial Cross-flow filtration for discovery, scale-up and process clarification/concentration applications lower binding and higher yields less fouling and longer service life faster flow rates and better economics easy scale-up / faster to market WaterSep s asymmetric void-free antifouling hollow fiber membranes offer high capacity and superior performance for your clarification and concentration applications. Our new proprietary membrane technology brings you enhanced product yields, high capacity, great selectivity, and less fouling during applications such as: primary recovery of recombinant biopharmaceuticals vaccine purification and concentration, debris removal (post-centrifugation) bacteria separation in fermentation broths cell harvesting/cell washing bioindustrial cell separation macromolecule concentration and diafiltration Hollow Fibers and primary recovery in Biopharmaceutical Filtration Many cell clarification processes employ centrifuges, single flow cartridges, and plate and frame depth filters, or combinations for cell removal prior to chromatographic separations. Due to incomplete removal of cells or cell debris in the product streams, down-stream chromatography columns can become fouled by these particulates leading to high pressure drops, unsatisfactory purification, and expensive premature failure of the chromatography media. WaterSep hollow fiber membranes are recommended for removal of cells and cell debris prior to chromatography separations, leading to extended service life and reduced cost of the chromatography columns. The low protein binding antifouling membranes excel at resisting fouling from anti-foam materials typically found in cell broths in these product streams. Reduced fouling leads to higher product transmission resulting in improved yields. Hollow fibers are also a very cost effective format for concentration/diafiltration of dilute biomolecule solutions. and are ideal in processes where single use membrane devices are desired. WaterSep antifouling membranes provide an advantage in cleaning during membrane recovery leading to: reduced chemical consumption less system downtime longer service life reduced risk for cross contamination minimized batch-to-batch variation WS REV 02

2 When your results need to be right, WaterSep consistently delivers... the right material WaterSep s membranes are manufactured using a unique combination of modified polyethersulfone (PES) and a proprietary spinning process. The result is a filter that exhibits exceptional chemical and physical properties. The antifouling properties of the membrane make it ideal for most applications involving lipids, as well as antifoam agents commonly used in fermentation broths. PES also meets the strictest regulatory requirements of biopharmaceutical processing. the right performance WaterSep membranes have a unique void-free structure, which is significantly stronger than competitive finger void membranes (see Figures 1 and 2). This structure results in a stronger cartridge with a longer surface life and significantly lower risk for fiber breakage and product loss. The membrane also has a very high water and process permeability, resulting in higher process capacity and lower cost of ownership. the right format Our HF filters accommodate particle-loaded process streams with significant improvement over traditional screen and open channel cassettes plate-and-frame systems, and spiral-wound cartridges. Rather than relying on retentate screens that risk particle entrapment, WaterSep cartridges avoid dead spots altogether with an open flow path. This construction also makes cleaning and sanitizing easier and more effective. Figure 1. WaterSep s void free structure provides a mechanically strong, more robust membrane with extended service life and reduced cost of ownership. Figure 2. Many traditionally manufactured membranes feature a finger-void construction, as shown here, which can lead to compromises in the strength of the membrane. This provides a superior format for the upstream clarification of many biopharmaceutical processes, and is also well suited for clarification and concentration operations during vaccine production. The cartridge construction makes cleaning and sanitizing easier and more effective. In addition, by design, WaterSep filters provide a straightforward scale-up process, going from laboratory volumes to pilot-scale to full manufacturing without a change in materials, membrane properties, or fluid paths (see Fig. 3). Figure 3. Scale-up made simple with a full spectrum of filters designed to take you from benchtop to production with no change in materials or construction parameters.

3 And the selection that helps you make the right choice too. The WaterSep product offering is based on 3 fluid path lengths that are consistent throughout the entire product line. This enables easy and reliable scale-up and scale-down of you process, by choosing between three different hollow fiber cartridge diameters: 1/2 (13mm), 1.3 (33mm), and 3.5 (89mm). Membrane cut-offs are available in: 10K-750K MWCO and 0.1 & 0.2 µm. explorer The Explorer series is recommended for membrane screening and laboratory volumes up to 15L. investigator The Investigator series is ideal for process development and pilot applications with 10L - 100L process streams. bioproducer The BioProducer series is our large scale high capacity hollow fiber cartridges for product batches up to several thousand liters. Retention Data for WaterSep 10K, 30K and 50K MWCO hollow fiber membrane Retention (%) K 30K 50K IgG Albumin The higher membrane flux (flow rate/unit surface area) and optimized hollow fiber packing density in our cartridges ensures larger process capacity and more economical systems with smaller footprint.

4 products and ordering Membrane selection assistance is available via telephone at and online at: Explorer product cart. diam. cart. length membrane area catalog number Explorer 12 ½ (13mm) 12.3 (312mm) 0.16 ft 2 (155 cm 2 ) WA XXX 10 EXP 12 S0 Explorer 24 ½ (13mm) 23.8 (605mm) 0.34 ft 2 (320 cm 2 ) WA XXX 10 EXP 24 S0 Explorer 41 ½ (13mm) 41.8 (1062mm) 0.62 ft 2 (580 cm 2 ) WA XXX 10 EXP 41 S0 Replace XXX with 010 for 10K, 030 for 30K, 050 for 50K, 100 for 100K, 300 for 300K, 500 for 500K, 750 for 750K, 990 for 0.1µm, 995 for 0.2µm Explorer 12 Explorer 24 Explorer 41 materials of construction membrane / cut-off: Modified-PES; 10K, 30K, 50K, 100K, 300K, 500K, 750K, and 0.1 & 0.2 µm. housing: White polysulfone encapsulant: FDA-compliant epoxy connections feed/retentate: permeate: 1/2 TC Barbed Hose Investigator product cart. diam. cart. length membrane area catalog number Investigator 12 1 (13mm) 12.0 (305mm) 1.4 ft 2 (0.13m 2 ) WA XXX 10 INV 12 S0 Investigator 24 1 (13mm) 23.5 (597mm) 3.0 ft 2 (0.27m 2 ) WA XXX 10 INV 24 S0 Investigator 41 1 (13mm) 41.5 (1054mm) 5.5 ft 2 (0.50m 2 ) WA XXX 10 INV 41 S0 Replace XXX with 010 for 10K, 030 for 30K, 050 for 50K, 100 for 100K, 300 for 300K, 500 for 500K, 750 for 750K, 990 for 0.1µm, 995 for 0.2µm Investigator 12 Investigator 24 Investigator 41 materials of construction membrane / cut-off: Modified-PES; 10K, 30K, 50K, 100K, 300K, 500K, 750K, and 0.1 & 0.2 µm. housing: White polysulfone encapsulant: FDA-compliant epoxy connections feed/retentate: permeate: 1 1/2 TC alt. 3 TC 1 TC

5 products and ordering BioProducer BioProducer with 1 1/2 TC Feed/retentate ports (GE Healthcare retrofit) Also available with 3 TC Feed/retentate ports (KOCH retrofit) product cart. diam. cart. length membrane area catalog number BioProducer (89mm) 15.0 (381mm) 13.5ft 2 (1.25m 2 ) BA XXX 10 PRO 12 SG 13.5 (344mm) 13.5ft 2 (1.25m 2 ) BA XXX 10 PRO 12 SK BioProducer (89mm) 26.5 (673mm) 29.3ft 2 (2.72m 2 ) BA XXX 10 PRO 24 SG 25.0 (636mm) 29.3ft 2 (2.72m 2 ) BA XXX 10 PRO 24 SK BioProducer (89mm) 44.5 (1130mm) 54.0ft 2 (5.0m 2 ) BA XXX 10 PRO 41 SG 43.0 (1093mm) 54.0ft 2 (5.0m 2 ) BA XXX 10 PRO 41 SK Replace XXX with 010 for 10K, 030 for 30K, 050 for 50K, 100 for 100K, 300 for 300K, 500 for 500K, 750 for 750K, 990 for 0.1µm, 995 for 0.2µm BioProducer 12 BioProducer 24 BioProducer 41 materials of construction membrane / cut-off: Modified-PES; 10K, 30K, 50K, 100K, 300K, 500K, 750K, and 0.1 & 0.2 µm. housing: White polysulfone encapsulant: FDA-compliant epoxy connections feed/retentate: permeate: 1 1/2 TC alt. 3 TC 1 TC WaterSep can easily plug-in to existing applications and processes. Connections and overall dimensions are compatible with competitive cartridges for easy and effective retro fit. Just by replacing your current hollow fiber cartridge with an optimized WaterSep product you can achieve higher capacity and higher yield in your process. Do you have an application we can improve? Process engineers, designers, and others facing difficult filtration challenges are encouraged to call WaterSep s Innovation Team to discuss customized or OEM solutions.

6 WaterSep Technology Corporation 420 Maple Street, Suite 1 Marlborough, MA USA Ext 204