Transcription of Presentation - Manufacturing process of biologics
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Presentation - Manufacturing process of biologics
2011 ICH1 Manufacturing process of biologicsK. HoAfssaps, France 2011 ICHI nternational Conference on Harmonisation of Technical Requirementsfor Registration of Pharmaceuticals for Human UseDisclaimer: The information within this Presentation is based on the presenter's expertise and experience, and represents the views of the presenter for the purposes of a training workshop. 2011 ICH2 Production of recombinant proteinUnicellular system MulticellularsystemBacteriaYeastMammalia nTransgenic plantTransgenic animalInsectManufacturing processOrganism naturally expressing protein of interestGene of interestProtein of interestGene of interestWild vectorExpression vectorGenetically modified organism expressing protein of interestManufacturing processVial WCB WCB WCB vial # vial # CLONEWCB #1 Vial WCB WCB WCB #2 Vial WCB WCB WCB #xMCB vial #11 MCBM anufacturing process 2011 ICH6 FermentationPurificationPurified proteinCell bankManufacturing process 2011 ICH7 ICH documents for biologics Q5 A: Viral Safety Q5 B: Genetic Stability Q5 C: Product Stability Q5 D: Cell Substrates Q5 E: Comparability Q6 B: Specification M4 / M2: CTD / e-CTD Q7: GMP for APIs Q8: Pharmaceutical development Q9: Quality Risk Management Q10.
• Description: o Applicant’s commitment for the manufacture of the drug substance. o Manufacturing process and process controls. o Typically starts with a vial(s) of the cell bank, and includes cell culture, harvest(s), purification and modification reactions, filling, storage and shipping conditions. • Batch(es) and scale definition: o Explanation of the batch numbering …
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