Biosafety Concerns with Single Use Bioprocess Technology · Biosafety Concerns with Single Use...
Transcript of Biosafety Concerns with Single Use Bioprocess Technology · Biosafety Concerns with Single Use...
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Biosafety Concerns with Single Use Bioprocess Technology
Brian Petuch RBP CBSP Merck Global Safety & Environment
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SUBS
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SUBS
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SUBs (Single Use Bioprocess)
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Areas Benefitting from SUBs
rDNA protein production mAb production Therapeutic protein production Viral vector production
Lentivirus AAV Adenovirus
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Bioprocessing Steps
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Process for Bacterial & Yeast Products
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Process for Mammalian & Pichia Products
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Process for Viral Vector Production
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Large Scale Biosafety Guidelines
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Large Scale Biosafety Guidelines
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Classic Bioprocess Technology
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Classical Bioreactors
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Classical Filtration
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Classical Chromatography
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SUB Technology
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Stirred Rigid Wall Bioreactors
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Agitated Flexible Bag Bioreactors
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Non Agitated Flexible Bag Bioreactors
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Vessel Integrity and Pressure Relief
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Nunc Cell Factory
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Single Use Bioreactors for DOE Studies
Can contain up to 36 bioreactors
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Clarification
Centrifugation Depth Filtration Microfiltration
Separation of Particulate Filters rated by pore size
Ultrafiltration Separation of Macromolecules Filters Rated by MW Cutoff
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Centrifugation
CENTRITECH III Lab System For Mammalian Cell Harvesting
to Develop Seed Stocks
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Depth Filter Applications
Post fermentation cell/cell debris clarification
Pre chromatography clarification Post chromatography debris clarification Concentrated protein clarification DNA, virus removal
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Single Use Depth Filters
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Chromatography Applications
Virus removal DNA removal Virus purification Protein purification
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Viral Purification Chromatography
Purification of Adenovirus, AAV, and Lentivirus Vectors
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Other SUB Areas
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Sampling
Bad Idea for
Pathogens!
Where does the waste go?
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Sampling
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Fittings
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Vent Filtration
Hydrophobic vs.
Hydrophilic
Heated vs.
Ambient Housings
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Vent Filtration
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Vent Filtration
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Performing a Process Risk Assessment
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Risk Assessment Parameters
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Risk Assessment Reference
http://bggo.rivm.nl/paginas/doc-ig.htm
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