Cytiva 和 Q-mation：利用 FlexFactory™ Historian 提高生物制造效率 - SyVento Biotech 案例研究.pdf

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1、 2025 AVEVAGroup Limited or its subsidiaries.All rights reserved.SESS-146Cytiva&SyVento:Enhancing Biomanufacturing Efficiency with FlexFactory HistorianTim Wortley Cytiva APRIL 9,2025Enhancing Biomanufacturing Efficiency with FlexFactory HistorianA Case Study from SyVento BiotechTim Wortley,CytivaCy

2、tiva4April 23,2025Presentation Title4Who are weMissionOur mission is to advance and accelerate therapeutics.VisionOur vision is a world in which access to life-changing therapies transforms human health.Cytiva5April 23,2025Presentation Title5Why it matters Lets meet EmilyImage result for emily white

3、head foundationCytiva6April 23,2025Cytiva7IntroductionCytivas FlexFactory historian biomanufacturing solution built on top of AVEVA PI System transforms mRNA manufacturing at Syvento Biotech in Poland.A discussion on the challenges in mRNA manufacturing and the transformative improvement on efficien

4、cy,costs and regulatory compliance from data managementCytiva8The regulatory landscape and market trendsWhy comply?Reputation,costs(fines),stay in business,access to global markets,directors&employees stay out of jail Well recognized guidance documents on how to deliver safe and effective drugs.Simi

5、lar standards apply globally.How to comply(data)“If it didnt get documented(reviewed,approved,signed),it didnt happen”The(process,instrument,analytical,manufacturing)data is sacrosanct,must be original and proven tamperproof.Complex Trends“Zoo”of biotherapeutics(mAbs,mRNA,AAV,pDNA,siRNA,EBT)Faster,c

6、heaper,simpler(Viz SARS-COV2 vaccine in 11months2,typically many years1,3)1.The development of COVID-19 vaccines in the United States:Why and how so fast?PMC2.Emergency authorization Dec 2020,Approval Dec 2021 COMIRNATY|FDA3.Mercks Gardasil was in development at U-Queensland in 1991 to approval in 2