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The
detailed Expression System Analysis and
confirmation of different elements present
in the expression cassette, is mandatory for
the regulatory submission of
biopharmaceutical product derived using rDNA
technology. The process bulk protein
production from the bacterial / yeast /
fungal expression system includes,
preparation of working Cell bank (WCB) from
Master Cell Bank (MCB) which can lead to
mutation or any alteration in the Expression
System. The FDA and other regulatory
authorities therefore seek the supporting
document on Expression System with foreign
gene analysis.
To
address the requirement, JRF has started
Expression System Analysis service to
generate data for regulatory submission to
meet the requirement of ICH guidelines for
Analysis of the expression construct in
cells used for production of r-dna derived
protein products. JRF offers full range of
service which includes Characterization of
MCB and WCB for the expression system
stability, Restriction site analysis of
plasmid and insert gene, Gene confirmation
and gene sequencing, Antibiotic resistance
property, Genotyping of bacterial host cell
by API20E system and report preparation.
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