3. 遺伝子治療用医薬品及び細胞治療用医薬品の品質・安全性等の確保(セミナー : 生物学的製剤と食品の品質保証と安全対策)
3. Some Aspects of Quality Control of Agents for Gene Therapy and Cellular Therapy(Seminar : Quality Assurance of Bilologicals and Foods, and Safety Programs in their Production)

Takao HAYAKAWA
1999 Cryobiology and Cryotechnology  
DNA technology and cell culture technology has enabled 皿 s to produce new medically useful agents for gene therapy and cellular therapy . To enable these products to be of use in human therapy , it is esse 飢 iahhat suit日 ble meas ロ es be taken by the manufacturers and control authority to assure quality , efficacy , and safety . This a 血 cle descnbes points , based on the latesI sound scientific principles , to be considered for producing, testing, e 曲 ating and controlling pharrnaceutical
more » ... cts for gene therapy and cellular therapy , especially with respect to their quality and safety .
doi:10.20585/cryobolcryotechnol.45.1_18 fatcat:zloxcja4tffjhgj252ole4nw7u