Post Production Cell Bank (PPCB)

Post Production Cell Bank (PPCB)

 

Post Production Cell Bank (PPCB) 생산종료세포

= End of Production Cell Bank (EoPCB)

 

 

배양 종료 후 세포 수확 바로 전 단계의 세포를 말합니다. 재조합 단백질의 유전적 안정성을 확인하기 위하여 PPCB Test를 진행합니다. 세포 배양 중 세포 특성의 변화 유무를 확인하기 위한 것으로 염기서열이 배양을 통해서도 안정되게 유지되는 지를 확인하기 위한 것입니다.

 

PPCB (Post Production Cell Bank)

 

FDA Guidance for Industry에 따르면...

 

You should characterize cells that are expanded to or beyond the end of production passage level. Such cells are referred to as End-of-Production Cells (EOPC). You should demonstrate the stability of the cell substrate characteristics using your EOPC. Your characterization should include, if applicable, growth characteristics, tumorigenic phenotype, expression of endogenous viruses, stability of expression of the inserted or engineered genes, and genetic stability of the cells (such as karyotyping or DNA fingerprinting).

 

 

 

Reference

- FDA, Guidance for Industry Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications(2010), C. Cell Banking

- 식약청 생물의약품본부, 생명공학의약품 생산세포주 관리를 위한 시험방법(2007)