ICH Q6 修订全球统一规范.pdf

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1、ICH Q6 Revision towards globally harmonized specificationsTakahiro YamaguchiAsahi Kasei Pharma Corporation10 December 2024CMC strategy forum Japan 2024Disclaimer:The views and opinions expressed herein are those of the presenter and should not necessarily represent the views and opinions of the orga

2、nization that the presenter is belonging.Outlines1.Introduction Advancement from endorsement of Q6 Reasons for Q6 revision2.Expectations and challenges for Q6 revision Principles for specification setting Prior knowledge Holistic control strategy23Biological Product GrowthGlobal Sales in 2000RankBra

3、nd NameSales(USD M)1Prilosec/Losec6,2602Zocor/Lipovas5,2803Lipitor5,0314Norvasc3,3625Pravachol/Mevalotin3,3486Claritin3,0117Prevacid/Takepron2,9568Procrit2,7099Celebrex2,641 10Prozac2,574Source:Uto Brain News Release(https:/www.utobrain.co.jp/news-release/2001/070600/ubrelease200107.pdf)Global Sales

4、 in 2023RankBrand NameSales(USD M)1Keytruda25,0112Comirnaty15,3053Humira14,4044Ozempic13,8925Eylea12,8766Eliquis12,2067Biktarvy11,8508Dupixent11,5909Stelara10,85810Darzalex9,744Red:recombinant proteinSource:Drug Discovery and Development(https:/ advancements lead to:deep product and process understa

5、ndingdevelopment biopharmaceutical product with enhanced quality,safety,and efficacyaccelerated development of therapeutic biologics and availability to patients4Advancements in Biological Field Manufacturing technology Engineering:in-silico design,developability evaluation,machine learning Expressi

6、on system:target integration,rapid clone selection,host cell engineering Manufacturing process:chemical-defined media,high-capacity resin,platform technology Equipment:single-use technology Analytical technology Mass spectrometry,multiple attribute method Next generation sequencing Analytical kit,au