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

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Presentation on theme: "An introduction to a novel filtration system ATF-manufacturing Platform Microcarrier Process Unit Operations Vaccines Gene Therapy Stem Cells."— Presentation transcript:

1 An introduction to a novel filtration system ATF-manufacturing Platform 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 3 Microcarriers: Process Overview SIP: PBS & ucarriers Wash ucarriers Innoculate Batch/perfusion growth Trypsinization Wash Cell transfer Reactor seed train 5x volumes 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… X X Maybe ?

4 4 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 –Low shear cell/seed transfers –Rapid Harvest –Microcarriers do not need to settle Cell ”health” improved, allowing higher productivity per cell Media removal can be to a low volume Simple to operate and scales to manufacturing External system which allows easy exchange of filter if required Microcarrier Processes: ATF System Advantages

5 5 Microcarriers: ATF2 System Setup

6 6 Microcarriers: ATF10 System Setup

7 7 1.Reactor filled with carriers and PBS 2.Reactor is SIP’d 3.ATF is autoclaved 4.Steamed connection made 1.PBS removed at 1vv/hr for mins 2.Addition of media 3.Diafiltrate for 5 minutes 4.Close harvest, media added to working volume 5.Innoculate with cells ATF rate constant at 4-5x filtrate rate Microcarriers: Preparation & Washing

8 8 1.Perfusion carried out at small or large scale 2.Rates at 0.5vv/day to 4vv/day 3.ATF rate at 30+ higher than filtrate rate Microcarriers: Perfusion

9 9 1.Cell growth to maximum in batch or perfusion mode 2.Media reduction at 1vv/hr for mins 3.Trypsinise cells 4.Harvest cells through ATF leaving behind carriers 5.Diafiltrate with new media, to capture maximum number of cells 6.Cells transferred directly to next reactor 7.ATF rate at 3-5x filtrate rate Microcarriers: Seed Transfer

10 10 1.Remove media at 1vv/hr for mins 2.Addition of new media 3.Infect cells with virus 4.Optional: Perfusion 1.Harvest cells and debris at 1 vv/hr for mins 2.Diafiltrate for minutes 3.Optional: Clarification with ATF and 0.2u filter on holding tank ATF rate constant at 4-5x filtrate rate Microcarriers: Media Exchange, Infection, Harvest

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


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