Some methods for contamination testing of a master cell bank

BioPharm

Volumn 13, Issue 6, 2000, Pages 48-52

  Del Rosario Aleman, M ^a   Valdes, R ^a   Perez, M ^a   Ibarra, N ^a   Reyes, B ^a   Gonzalez, M ^a   Mendoza, O ^a   Padilla, S ^a   Agraz, A ^a   Rodriguez, M P ^a  

^a Monoclonal Antibody Division   (Cuba)

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY;

ARTICLE; ASSAY; BACTERIUM; BIOPROCESS; CELL CULTURE; CELL LINE; CELL POPULATION; CLONE; CONTAMINATION; DRUG MANUFACTURE; METHODOLOGY; MYCOPLASMA; PRACTICE GUIDELINE; VIRUS;

EID: 0033847799     PISSN: 10408304     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (24)

1. EEC regulatory documents, note for guidance: Validation of virus removal and inactivation procedures
2. Ethical considerations in the testing of biopharmaceuticals for adventitious agents
3. Establishing cell banks under current good manufacturing practices
4. Process validation for virus removal and inactivation
5. A mouse hybridoma cell line secreting IgG and IgM antibodies with specificity for the hepatitis B virus surface antigen
6. Antigen recognition characteristics and comparative performance in immunoaffinity purification of two monoclonal antibodies specific for the hepatitis B virus surface antigen
7. Statistical analysis of repetitive subcloning by the limiting dilution techniques with a view toward ensuring hybridoma monoclonality
8. Caracterizacion de Anticuerpos Monoclonales Contra el Antigeno de Superficie del Virus de la Hepatitis B
9. Measurement of monoclonal antibody affinity by noncompetitive enzyme immunoassay