We provide physiochemical characterization services ranging from protein structure confirmation to amino acid content detection. We also quantify free cysteines and detect product impurities such as glycation and deamidation.
Backed by our strong protein chemistry background, we enable ‘Finger-Print’ protein structure and functional characterization for proteins from naked proteins to hyper-glycosylated or derivatized proteins.
Our biological characterization capability enables a sound understanding of the biological mechanism of action of the product. We can support a wide variety of biological assays including, cell-proliferation or killing, binding affinity, cell signaling, and viability or endpoint assays using both transformed cell lines and primary cells.
Physiochemical Characterization
We provide physiochemical characterization services ranging from protein structure confirmation to amino acid content detection. We also quantify free cysteines and detect product impurities such as glycation and deamidation.
The ability is based on a diverse platform of instruments and technologies supported by a fully-trained technical staff:
- 21 CFR part 11 and GAMP compliant system-based labs
- Comprehensive infrastructure to support orthogonal confirmation of product parameters
- Experience across diverse protein expression systems
Catalog:
- Primary structure: Intact mass and fragmented mass
- Higher order structure: secondary and tertiary structure, melting point, disulfide linkage and free thiol
- Post-translational modification: oligosaccharide profiling, oxidation, deamidation and cleavage
- Product/process - related impurities: size and charge variant analysis
- Technology: Mass spectrometry, HPLC, UPLC, spectroscopy, circular dichroism, fluorometry, DSC DLS, SEC MALS, ion chromatography, CEIEF, CESDS and solo VpE
- Protein: mAb, Fab, fusion protein, cytokine, enzyme, hormone, hyperglycosylated proteins and derivatized proteins
Biological Characterization
Our capability in luminescence and fluorescence-based assays and flow cytometry enables a wider reach of biological characterization. In addition, we also develop bio-assays for clinical sample analysis and immunogenicity assessment:
- Development of bioassays and cell-based assay employing primary and derived cell lines
- Expertise in luminescence, fluorescence and flow cytometry-based assay
- Wide variety of cell signaling and endpoint assays – ADCC, CDC and proliferation
- Ability to handle clinical samples
Catalog:
- Signaling: GPCR, calcium release, kinase and phosphorylation
- Binding: Direct/indirect ELISA, competition ELISA and surface plasmon resonance (BIAcore)
- Viability: ADCC, CDC and proliferation
- PK/PD: Serum drug concentration, immunogenicity and neutralizing antibody
- Technology: Luminescence and fluorescence-based methods, multicolor flow cytometry, microscopy and primary cell culture
- Protein: mAb, Fab, fusion protein, cytokine, enzyme, hormone, hyperglycosylated proteins and derivatized proteins
Why Aurigene Pharmaceutical Services?
ALCOA+ driven quality systems
Diverse platform of instruments and technologies
Integrated approach to safety and quality management systems
In-house capability across the value chain with a trained scientific staff
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Bangalore R and D Center
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Resources
JUNE 28, 2022
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Building successful long-term partnerships with CDMOs from early drug discovery through commercialization
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