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Primary Structure Confirmation
High-precision amino acid sequence verification and accurate mass determination for full structural identity.
Peptide & Protein biosimilars Characterization
Deploying advanced high-resolution mass spectrometry and orthogonal physicochemical techniques to ensure structural and functional sameness for complex peptide therapeutics.
Analytical Capabilities
Our instrumentation suite is designed for ICH-compliant characterization and comparative assessment between biosimilar candidates and reference listed drugs.
Amino Acid Sequencing & Peptide Mapping
Detailed de novo sequencing and peptide fragment analysis to map the complete molecular fingerprint.
Disulfide Bond Mapping
Confirmation of disulfide linkages under native and reduced conditions to ensure correct folding.
Aggregation & Higher-Order Structure
In-depth assessment of conformational integrity, oligomerization, and secondary structure.
Comparative Analytical Assessment
Rigorous head-to-head comparison with RLD using statistical similarity analysis frameworks.
Impurity Profiling & Related Substances
Quantitation of process-related and product-related impurities including degradants.
Physicochemical Characterization
Profiling of purity, post-synthetic modifications, and intrinsic physicochemical properties.
Stability & Forced Degradation
ICH-compliant profiling under thermal, oxidative, and photolytic stress conditions.
Receptor Binding & Potency Assays
Functional characterization through sophisticated receptor binding and cell-based bioassays.
Immunogenicity Assessment
Comprehensive Anti-Drug Antibody (ADA) screening and supportive bioanalytical services.
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Contact the ICT Mumbai Nanomedicine Research Group for collaboration, bioanalytical support, or characterization services.
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