PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – B9. PRODUK TERAPI GEN

PIC/S ANEKS 2 (PEMBUATAN BAHAN DAN PRODUK BIOLOGI UNTUK PENGGUNAAN MANUSIA) – B9. PRODUK TERAPI GEN35

NO VERSI ASLI VERSI TERJEMAHAN 35 In the EEA, Part IV (1) of Directive 2001/83/EC as revised in 2009 contains a definition of gene therapy (GT) medicinal products

35 Dalam EEA, Bagian IV (1) dari Direktif 2001/83/EC sebagaimana telah direvisi pada tahun 2009, berisi definisi produk obat Terapi Gen.

There are potentially 2 types of GT products (vectors and genetically modified cells) and both are within the scope of the guidance in this section. For cell based GT products, some aspects of guidance in section B10 may be applicable.

Ada 2 jenis produk Terapi Gen (vektor dan sel hasil rekayasa genetika) dan keduanya berada dalam lingkup pedoman di butir ini. Untuk produk Terapi Gen berbasis sel, beberapa aspek pedoman dalam butir B10 dapat diterapkan.

1 Since the cells used in the manufacture of gene therapy products are obtained either from humans (autologous or allogeneic) or animals (xenogeneic), there is a potential risk of contamination by adventitious agents. Special considerations must be applied to the segregation of autologous materials obtained from infected donors. The robustness of the control and test measures for such starting materials, cryoprotectants, culture media, cells and vectors should be based on QRM principles and in line with the MA or CTA. Established cell lines used for viral vector production and their control and test measures should similarly be based on QRM principles. Virus seed lots and cell banking systems should be used where relevant.

Karena sel-sel yang digunakan dalam pembuatan produk terapi gen diperoleh dari manusia (autologus atau alogenik) atau…