Biomedical Engineering Reference
In-Depth Information
TABLE 12.1 Tests for Master Cell Banks (MCBs)
Tests for Master Cell Banks (MCBs)
Attribute
Test Methods
Microbiological contamination
Bacteriostasis and fungistasis
Sterility
Mycoplasma (cultivable and noncultivable strains)
Endotoxin
Cell line identification
Isoenzyme analysis/DNA fingerprinting or karyology
Copy number determination
Restriction map analysis
DNA/RNA sequencing
Retroviruses
Reverse transcriptase, infectivity assays, PCR-based
assays
Adventitious viruses
In vitro
and
in vivo
assays for viral contaminants
Specific virus assays
Antibody production assays, for example, mouse
antibody production (MAP) assay or hamster
antibody (HAP) production assay; PCR-based
assays
Other virus assays
Specific bovine or porcine virus assays
TABLE 12.2 Tests for Working Cells Banks (WCBs)
Tests for Working Cell Banks (WCBs)
a
Attribute
Test Methods
Microbial contamination Bacteriostasis and fungistasis
Sterility
Mycoplasma (cultivable and noncultivable strains)
Endotoxin
Adventitious virus testing
In vitro
and
in vivo
assays for viral contaminants
Cell line identification DNA fingerprinting or karyology or isoenzyme
analysis
a
Limited testing is required because WCBs generally originate from a well-characterized MCB.
the ability of their purification and manufacturing processes to produce a prod-
uct that is safe for use in humans. Incoming raw materials (such as animal-
derived serum) for cell banking should be assessed for risk of contamination, for
example, transmissible spongiform encephalopathy (TSE) or bovine spongiform
encephalopathy (BSE). Moreover, the type of testing required needs to be host
dependent. Elimination of the use of animal-derived raw materials/excipients,
selection of cell substrates with low inherent viral (or phage) risk, and the imple-
mentation of appropriate in-process and lot release detection tests are all important
strategies to mitigate the risk of viral and TSE/BSE contamination. The documen-
tation regarding viral and TSE/BSE clearance studies are required by regulatory
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