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An introduction to a novel filtration system

An introduction to a novel filtration system. ATF-manufacturing Platform Upstream Unit Operations ATF- cellcultivation Concentrated Perfusion Concentrated Fed-Batch Hybrid Processes. Fed-Batch. Per Run *. 20 Runs/Yr. 100L. 50g. 1kg. 300L. 150g. 3kg. 1000L. 500g. 10kg. Perfusion.

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An introduction to a novel filtration system

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  1. An introduction to a novel filtration system ATF-manufacturing Platform Upstream Unit Operations ATF-cellcultivation Concentrated Perfusion Concentrated Fed-Batch Hybrid Processes

  2. Fed-Batch Per Run * 20 Runs/Yr 100L 50g 1kg 300L 150g 3kg 1000L 500g 10kg Perfusion Per Day * 30 Day Run 10 Runs/Yr 100L 50g 1.5kg 15kg 300L 150g 4.5kg 45kg 1000L 500g 15kg 150kg Avid Bioservices Facilities * 500 mg/L post purification yield Capacity cannot be calculated solely by bioreactor size 15x more product in the same time! 2

  3. Why use Perfusion in Research, even if not later... • Perfusion produces more material in a shorter time period • Do you have time to make a new cell line? • Do you have time to develop a special media? • Pre-clinical material can be produced faster with less development effort • A low producing cell line can be used to produce enough material in a shorter time for a phase 1 trial • Smaller bioreactors are required at all stages of PD and Manufacturing - saving significant capital cost • One continuous culture experiment can perform multiple metabolic studies to understand clone behavior in different design spaces, significantly faster than in batch or fed-batch • Upstream development times may be reduced due to simpler feeding

  4. Perfusion and Concentrated Perfusion • Perfusion is dead - Long Live Concentrated Perfusion !! • What is Concentrated Perfusion? • Onlypossible with the ATF • Ultra-highviable cell densities, in the region of 60-150m / ml • Requires 1-3 vv / day media (not more) • Same simple process control as perfusion & CFB – buthigherproductivity • Whenshouldperfusion be used and not Concentrated Perfusion? • When the productquality is affected by cell concentration, or if protein expression depends on a dilutetoxic species

  5. Concentrated Perfusion • “Standard” perfusion application but with the ATF System • high cell concentration (60-100m/ml), 30-60 days • Straight-forwardfeedingcontrol,removal of metabolites & proteins • Continuousfilteredharvests, oftenpooled (every 3-6 days) for easier DSP • ~0.1g/L/day per 10m cells /ml for an average cell line (10pg/cell/day at 2vvd) ATF rate constant at minimum ~0.05-0.1 vv / min Feeding controlled by level probe Filtrate pump runs at 0.5-3 vv / day or as required by cell growth MF filter retains cells inside reactor while molecules filter through

  6. CHO Perfusion Results Graph taken from Genetic Engineering News October 2007

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