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An introduction to a novel filtration system

An introduction to a novel filtration system. ATF-manufacturing Platform Microcarrier Process Unit Operations Vaccines Gene Therapy Stem Cells. Microcarrier Screen Filter Module. All USP Class VI materials (Polysulfone, Polyester, epoxy, 316L SS) 70um screen

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An introduction to a novel filtration system

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  1. An introduction to a novel filtration system ATF-manufacturingPlatform Microcarrier Process Unit Operations Vaccines Gene Therapy Stem Cells

  2. Microcarrier Screen Filter Module • All USP Class VI materials (Polysulfone, Polyester, epoxy, 316L SS) • 70um screen • Special flow path design to reduce fouling and attachment • Multiple low shear, rapid, separations, without settling: • Media exchanges, wash steps • Seed transfer • Harvest: cell debris & virus filtration from microcarriers

  3. Microcarriers: Process Overview Reactor seed train 5x volumes X X Maybe ? SIP: PBS & ucarriers Wash ucarriers Innoculate Batch/perfusion growth Trypsinization Wash Cell transfer SIP: PBS & ucarriers Wash ucarriers Innoculate Batch/perfusion growth Trypsinization Wash Cell transfer SIP: PBS & ucarriers Wash ucarriers Innoculate Batch/perfusion growth Media reduction Infection Media addition Harvest 50+ flasks… 3

  4. Microcarrier Processes: ATF System Advantages • Major advantage is liquid and microcarrier handling: ease and speed to remove or transfer media or cells • Rapid liquids removal without shear • Wash steps for carriers • Lowshearcell/seed transfers • Rapid Harvest • Microcarriers do not need to settle • Cell ”health” improved, allowinghigherproductivity per cell • Media removal can be to a lowvolume • Simple to operate and scales to manufacturing • External system which allows easy exchange of filter if required 4

  5. Microcarriers: ATF2 System Setup 5

  6. Microcarriers: ATF10 System Setup 6

  7. Microcarriers: Preparation & Washing Reactor filled with carriers and PBS Reactor is SIP’d ATF is autoclaved Steamedconnectionmade PBS removed at 1vv/hr for 40-50 mins Addition of media Diafiltrate for 5 minutes Close harvest, media added to workingvolume Innoculate with cells ATF rate constant at 4-5x filtrate rate 7

  8. Microcarriers: Perfusion Perfusion carriedout at small or largescale Rates at 0.5vv/day to 4vv/day ATF rate at 30+ higherthanfiltrate rate 8

  9. Microcarriers: Seed Transfer Cell growth to maximum in batch or perfusion mode Media reduction at 1vv/hr for 30-40 mins Trypsinise cells Harvest cells through ATF leavingbehindcarriers Diafiltrate with new media, to capture maximum number of cells Cells transferred directly to nextreactor ATF rate at 3-5x filtrate rate 9

  10. Microcarriers: Media Exchange, Infection, Harvest • Remove media at 1vv/hr for 40-50 mins • Addition of new media • Infect cells with virus • Optional: Perfusion • Harvest cells and debris at 1 vv/hr for 40-50 mins • Diafiltrate for 10-20 minutes • Optional: Clarification with ATF and 0.2u filter on holding tank ATF rate constant at 4-5x filtrate rate 10

  11. Adherent Cells: Combined DSP Buffer, Wash Vaccine Process – Adherent Cells Ionic Solution (hc-dna precipitation) 70u filtered stream 0.2u or 0.5u filtered stream Clarified Harvest Microcarrier-free Harvest Production reactor

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