NovaSet Cassettes Brochure

Y o u r P a r t n e r i n P e r f o r m a n c eèNovaSetTM CassettesFor Pilot Scale and Commercial ApplicationsBenefit of Selecting NovaSetTM Cassettes: • Optimized channel geometry • Reliable scale-up performance• Rigid cassette designProduct Data ProfileProduct Data ProfileProduct Data ProfileAt pilot stage, the primary membrane candidate has been chosen, as process parameters. Typically at this stage, the production method is being verified and production materials produced for toxicology or pre-clinical trials and predictable scalability is imperative.In order to facilitate the manufacturing life cycle of a successful therapeutic candidate, cGMP manufacturing needs to begin at relatively small scale to facilitate human clinical trials. Manufacturing material for this early pilot scale manufactu-ring can easily and effectively be accomplished using the TangenX NovaSetTM UF and MF cassettes. Like the corresponding NovaSetTM-LS process development membrane cassettes, NovaSetTM pilot and process scale cassettes are available in a comprehensive range of options that are directly scalable from earlier development using the NovaSetTM cassettes. Optimized channel geometry and enhanced device rigidity ensures hydraulic performance is maintained when scaling up through the NovaSetTM-LS and NovaSetTM cassette family resulting in optimal and reproducible scaling performance.Additionally, each cassette undergoes rigorous QA lot release testing to verify its meets specification. Cassettes are tested for both air integrity and for their hydrodynamic performance. This testing ensures cassette-to-cassette consistency, resulting in scalable process development and reproducible manufacturing. Graph 1 shows the pressure drop vs. cross-flow specification for the NovaSetTM cassettes. Graph 2 shows the TMP vs. water flux for a typical 10 kD NovaSetTM Cassette. Graph 1: Pressure drop vs. cross-flow flux-NovaSet™ “L“ ScreenGraph 2: Transmembrane pressure vs. water flux-NovaSet™ 10 kDAverage CFF (L/min/m2 )Water fl ux (LMH)Pressure drop (psi)Transmembrane Pressure (psi)uuHigh RangeLow Range NOTES: Specified Pressure Drop Range for all B05 and B15 NovaSet™ “L“ Screen Cassettes with purified water at 25°Cu NovaSet™ NOTES: Typical NWP for the B05 and B15 NovaSet™ “L“ Screen Cassettes with purified water at 25°CApplication Performance:NovaSet™ 0.5 m2 & 1.5 m2 devices are designed for processing volumes from 10’s to 1 000’s of liters.u NovaSet™-LS processing volume capability: Depends on MWCO, TMP and fouling but as a guide a 10 kD membrane run at 2 bar TMP typically handles 200 lmh or 100 lph for the 0.5 m2 and 300 lph for the 1.5 m2.u Concentration factors: Typically 3-100 X used in conjunction with a Novasep Process engineered system.NovaSet™ cassettes represent the latest development in tangential flow filtration cassette design and performance. The TangenX line of cassettes has been designed to deliver optimal performance as well as demonstrate exceptional batch-to-batch reproducibility.Product Data ProfileCassette Selection and Optimization:Several factors affect process scale-up, including fluid path length, channel geometry and membrane performance. Through careful design and manufacturing these parameters are critically controlled to ensure linear process scale-up.Other factors such as batch composition, concentration, viscosity, working volume, and processing time should all be consi-dered when scaling-up the cassette process. Careful attention must be paid to pressure and flow-rates of the process as well. Each will have an impact on the process and must be well understood. Experienced application engineers are available on request for technical support and guidance throughout the scale-up process.The NovaSet™ cassettes are available in a wide range of membrane pore sizes from 1 kD to 0.2 µm, in both ProStream™ and HyStream™ mPES membrane types.NovaSet™ cassettes are available in 0.5 m2 and 1.5 m2 surface area formats as well as three different channel configurations:u High pressure channel “H” Screen is ideal for dilute streams where high flux and lower recirculation rates are desired.u Low pressure channel “L” Screen is ideal for medium viscosity streams where a lower pressure drop is desired.u Suspended Screen channel “S” Channel is ideal for streams of high viscosity or of ones containing particulates. This geometry is ideal for cell clarification.0.5 m2, 1.5 m2 NovaSet™ Cassettes & BlocksAll-in-one processing convenience for 10’s to 1.000’s of liter biopharmaceutical samplesApplicationsBiopharma, Biotech, Life Sciences: t Concentrate and desalt proteins, peptides, nucleic acids (DNA, RNA, oligonucleotides)t Separate and purify biopharmaceuticalst Recover and purify antibodies or recombinant proteins from culture cell mediat Fractionate dilute protein mixturest Remove pyrogens from water, buffers, and media solutionst Sample preparation prior to chromatographyConfiguration B - Industry Standard Product Data ProfileOrdering & SpecificationsConstruction Materials Max TMP at 30°C Cross-Flow Rate (L/min/m2))Membrane Polyethersulfone Forward 7 bar (100 psig) H Screen 6-9 at 1.0 bar (14.7 psi)Suppports Polypropylene Reverse 0.33 bar (7 psig) L Screen 6-9 at 0.07 bar (10 psi)Screens Polypropylene “S“ Channel 9-15 at 0.1 bar (1.5 psi)Adhesive UrethaneManufacturing & Quality:NovaSetTM cassettes are manufactured and quality controlled in a cGMP compliant manufacturing facility. Quality control lot release testing includes 100% device integrity and hydrodynamic testing.Each NovaSetTM device is individually packaged in a sealed foil lined bag and outer cardboard carton. Each cassette is packaged “wet” in 20% Glycerin and 0.1% Sodium Azide to prevent membrane drying and loss of performance. A regulatory support file is available upon request including USP Class 6 toxicological testing and leachable & extracta-ble testing, etc.ContactsSpecifications:PPolypropyleneUF MCWCO -kD• 001 = (1 kD etc.)Pore Size - µ• M10 = (0.1 µ etc.)0 0 10 0 30 0 50 1 00 3 00 5 01 0 03 0 0M 1 0M 2 0B 0515PXMembraneP - ProStream™X - HyStream™Surface Area05 - 0.5 m215 - 1.5 m2Screen GeometryH - High Pressure ScreenL - Low Pressure ScreenS - “S“ Channel ScreenY o u r P a r t n e r i n P e r f o r m a n c ewww.novasep.comEUROPE - Novasep ProcessSite Eiffel 81, boulevard de la Moselle - BP 5054340 Pompey - FRANCEPhone: + 33 (0)3 83 49 70 00Fax: + 33 (0)3 83 49 70 02biopharma@novasep.comUSA - Novasep, Inc.23, Creek CircleBoothwyn, PA 19061 - USAPhone: + 1 610 494 0447Fax: + 1 610 494 1988biopharma@novasep.comHLS BeCom'>"?:akVXdb?"??;8?8dbResponsible Forest Management