GMP Facilities for Manufacturing of Advanced Therapy Medicinal Products for Clinical Trials: An Overview for Clinical Researchers

被引：11

作者：

Alici, Evren ^{[1
,2
]}

Blomberg, Pontus ^{[3
]}

机构：

[1] Karolinska Univ Hosp Huddinge, Karolinska Inst, Dept Med, SE-14186 Stockholm, Sweden

[2] Karolinska Univ Hosp Huddinge, Hematol Ctr, SE-14186 Stockholm, Sweden

[3] Karolinska Univ Hosp Huddinge, Clin Res Ctr, SE-14186 Stockholm, Sweden

来源：

CURRENT GENE THERAPY | 2010年 / 10卷 / 06期

关键词：

ATMP; gene therapy; cell therapy; GMP; clinical grade; clean rooms; regulations; CELL;

D O I：

10.2174/156652310793797757

中图分类号：

Q3 [遗传学];

学科分类号：

071007 ; 090102 ;

摘要：

To be able to produce advanced therapy medicinal products, compliance with regulatory standards while maintaining flexibility is mandatory. For this purpose, careful planning is vital in the design or upgrade of a facility. Similarly, extensive foresight is elemental to anticipate upcoming needs and requirements. Failing this may lead to the facility's inability to meet the demands. In this chapter we aim to outline the current issues with regards to the European Union Directives (EUD) on advanced therapies, which impact gene and cell therapy facilities in Europe. This chapter is an attempt to elucidate what the minimum requirements for GMP facilities for gene and cell therapy products are and what is considered necessary to comply with the regulations in Europe.

引用

页码：508 / 515

页数：8

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