Analytical Development Laboratory / Bioassay Development Laboratory (ADL/BDL)
State of the art advanced analytics laboratory for establishment of biosimilarity at various stages of product development through filings, ICH based method development, qualification and validation, critical quality attribute (CQA) analysis using high end structural and functional assays, HT-PAT technology platforms for support of process development.
- Robust infrastructure to support Biochemical, Biophysical and Biological Activities
- Biochemical- Peptide Mapping, N-Terminal Sequencing, Disulfide bond analysis, Carbohydrate Analysis HPAEC-PAD, Glycosylation site, Sialic Acid Content, Intact mass analysis, LC-MSMS sequencing, SEC, CEX, CE-LIF, CE-SDS, cIEF, IEF, etc.
- Biophysical- UV / Fluorescence analysis - Tertiary structure, DSC - long term stability, CD - Secondary structure, etc.
- Biological Activity- Cell based Bioassays, ADCC/CDC testing, Flow cytometry, ELISA, PK/PD and immunogenicity testing, etc.