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Analytical Analytical

Analytical

We offer fit-for-purpose analytical solutions to our customers in a most efficient manner.

Analytical services are used to identify, isolate, or quantify molecules and to characterize their physical properties. We provide physiochemical and biological characterization services.

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/killing, binding affinity, cell signaling, and viability or endpoint assays using both transformed cell lines and primary cells.

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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
  • A comprehensive instrumentation infrastructure to support orthogonal confirmation of product parameters
  • Experience across diverse protein expression systems

Catalog:

  • Primary structure: Intact mass, fragmented mass, and Pep map
  • 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 Analytical 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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Connect with our scientific experts for your drug discovery, development, and manufacturing needs

We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.

Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.

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