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ELEMENT
TEST
MCB
WCB
Identity
Host cell


Isoenzyme analysis

DNA analysis:

• DNA fingerprinting

• Karyology

Expression construct


Expression of desired protein

Peptide sequence of desired protein

Sequence of expression construct

Copy number of expression construct

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Purity
Bacterial & fungal Sterility
Mycoplasma


Cultivable mycoplasma

Non-cultivable mycoplasma

Test for Retrovirus and other Endogenous virus


Infectivity

Electron microscopy

Reverse transcriptase

Other virus specific test

Test for non-Endogenous or Adventitious virus


In vitro assay

In vivo assay

Antibody production (MAP, RAP, HAP)

Other virus specific test

Cross-contamination


• Karyotyping

• RFLP analysis

• STR analysis

• DNA analysis

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Stability
Gene stability


Restriction endonuclease mapping

Copy number determination

Coding sequence of the expression construct

Cell line stability


Phenotypic

Growth rate

Cellular productivity

Genotypic

DNA & RNA analysis

Biochemically

Product quality

Physically

Functionally

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Suitability
Cell viability
Cell productivity

Tests

by Saeid

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