BIO-ANALYTICAL SERVICES
Bio-Analytical Services
Specializing in bioanalytical characterization, Mumbai Biocluster offers in-depth analysis of biologics to confirm identity, purity, and potency. Their advanced techniques ensure that each product batch meets stringent biopharmaceutical standards, vital for regulatory approval.
Our Services Includes
01
Mass Spectrometry and Chromatography-based Analysis
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Peptide Mapping and Protein Identification
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Protein Quantification and Characterization
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Glycan Analysis
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Impurity Profiling and Trace Analysis
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Method Development and Validation
03
Biophysical Characterization
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Assessment of structural and biophysical properties of biologic products and their aggregates.
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This includes techniques such as circular dichroism (CD), FTIR, and nuclear magnetic resonance (NMR) spectroscopy to elucidate protein folding, stability, and interactions.
02
Impurity Identification and Biosimilarity Studies
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Impurity Profiling
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Bio-similarity Assessment
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Host Cell Protein (HCP) Analysis
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Product-Related Variants Analysis
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Method Development and Validation
04
Stability Studies
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Protein aggregation studies, degradation studies, to observe the structural changes over time, to ensure product stability and integrity.