Our team is involved
in conducting stability studies for various
drug substances & drug products.
The active component
in biotechnological or biological products
is typically protein and/or polypeptide,
which are typically sensitive to environmental
factors such as temperature changes, oxidation,
ionic content & shear. To ensure maintenance
by biological activity and to avoid degradation,
stringent conditions for their storage are
usually necessary. Therefore a well defined
testing programme is designed to confirm
their stability during the intended storage
period, which in turn helps to determine
the shelf-life of drug products.
The stability study
involves a number of analytical methods to
determine purity, identity, activity and
safety of drug products and drug substances.
Analytical methods like determination
of protein content, SDS-PAGE (reducing & non-reducing),
RP-HPLC, SEC, IEF, Immunoblotting are routinely carried
out for samples at different storage condition i.e. & stress,
accelerated & real time.
Tests for safety, efficacy & biological activity
are also carried out in co-ordination with Cell culture & Microbiology
labs.
Summary
Storage & maintenance
of stability samples for various DS & DPs.
Analytical
tests like:
pH
Determination of protein
concentration
SDS-PAGE ( reducing & non-reducing
)
RP-HPLC
IEF
SEC
Immunoblotting
Microbial load test
Sterility test
Endotoxin test
Abnormal toxicity test
Biological activity
'' Tests are done in co-ordination with other labs.
