GMP cell line certification
Validated immunology data packages for the
qualification of cells for the GMP production of proteins or peptides
or other biotherapeutics in compliance with ICH Q5B and Q5D.
Example: viral contaminant determination, titer and quantification;
isoenzyme analysis; genetic stability of the transgene; copy number
stability of the transgene; genomic mapping and sequence stability; RNA
Expression throughout the process.
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