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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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