A statistical approach to determining criticality of residual host cell DNA.

Yang, Harry

A statistical approach to determining criticality of residual host cell DNA. [electronic resource] - Journal of biopharmaceutical statistics 2015 - 234-46 p. digital

Publication Type: Journal Article

1520-5711

10.1080/10543406.2014.972514 doi


Animals
Antibodies, Monoclonal--biosynthesis
Biopharmaceutics--standards
CHO Cells
Chemistry, Pharmaceutical
Consumer Product Safety
Cricetulus
DNA--analysis
Data Interpretation, Statistical
Dogs
Drug Contamination--statistics & numerical data
Guidelines as Topic
Humans
Influenza Vaccines--biosynthesis
Madin Darby Canine Kidney Cells
Models, Statistical
Quality Control
Risk Assessment
Technology, Pharmaceutical--methods