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Analytical Development & Functional Assays

Analytical Development & Functional Assays

ABio-therapeutic development programs, including creation of protein candidates and antibody molecules requires extensive studies on physiochemical and biological function characterization.

Success for any candidate lies in its ability to demonstrate potency, efficacy and safety in the Clinic. Our bioanalytical lab at Premas is engaged in building this foundation for the bio-therapeutic molecules we develop and support through their success in late stages. We understand the involvement it takes, and have deep understanding of the engagement and the diligence required.

For Biophysical characterisation of the molecules, we have established a portfolio of studies to understand the identification parameters, purity and impurity profile, concentration and aggregation issues and stability data.

Functional characterization is performed relating to biological properties of the molecules including development and conducting assays as ELISA, enzyme assays, bioassays as neutralization activity, proliferation assays, CDC and ADCC.

Throughout the development program for a biological candidate, the processes at Premas strictly adhere to the guidelines laid by EMEA, ICH and CDSCO, keeping in account the geography that the molecule is being produced for.