Guidelines
- GUIDELINES ON SIMILAR BIOLOGICS: Regulatory Requirements for Marketing Authorization in India, 2016
Resources
- Intact mass analysis of proteins
- Peptide mapping by LC-MS
- SEC-MALS as a tool for aggregation analysis
- Higher order structure analysis by CD spectroscopy
- Nano-DSC for protein characterization
- Tertiary structure analysis by Fluorescence spectroscopy
- Protein Estimation by Bradford assay
- Protein analysis by Gel electrophoresis
- Glycan Analysis by LC-MS
- Protein Protein interactions by SPR