ADL is involved in analysis of the drug at various
stages of development. It is responsible for the
development and validation of a wide range of analytical
test methods for establishing Identity, Purity,
Potency, Quantity and Safety. These tests are used
for lot- release, in- process testing and stability
testing of drug substances and drug products. The
validated methods are then transferred to the QC
laboratories as per requirement.
ADL lays down specifications
for the lot release of each batch, in-process testing
during the process as well as stability indicating
testing to assign shelf life of the drug.
The lab also undertakes
additional characterization of the API and their
impurities during the process development stages.
Further,
ADL carries out cell banking and characterization of
the different clones as per international (ICH) guidelines.
