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Analytical Development

Home Small Molecule CMC Analytical Development

Analytical Development

With extensive scientific knowledge and experience with the regulatory requirements of both the international and domestic markets, our Analytical Development Group provides strong support for drug substance and drug product development. The quality of our analytical development is backed by the experience of our highly skilled scientists and scientific management, state- of-the-art instrumentation, close cross-functional interaction, adherence to standard operating procedures, extensive regulatory training, and Quality Assurance oversight. All standard tests and protocols are carried out as per ICH and USP guidelines, where applicable.

Chemical and Formulation Development Support

  • Analytical methods development and validation
  • In-process control method development
  • Starting material and raw material testing
  • Impurity profiling
  • Impurity isolations and characterization
  • Degradation product characterization
  • Compatibility testing
  • Accelerated, intermediate and long term stability and forced degradation studies
  • Dissolution testing

Release Testing for Drug Substances and Drug Products

  • Methods development and validation
  • Purity assay
  • Total related substances
  • Dissolution and content uniformity
  • Residual solvent quantification
  • Moisture content assessment
  • Counter-ion determination
  • Compendia testing for elemental impurities, ROI, and LOD
  • Physical property measurement
  • Impurity and degradation product structural identification
  • Microbial limit tests(Ch.P&USP)
  • Documentation and Issuance of COA’s

Reference Standard Qualification as per ICH Guidelines
Accelerated and intermediate long term stability study as per ICH Guidelines

  • Service Overview
  • Discovery Chemistry
    • Synthetic Chemistry
    • Medicinal Chemistry
    • Library Chemistry
    • Peptide Chemistry
    • Fragment Based Screening
    • Computer Aided Drug Design
    • Analytical Services
    • Protein Structure
  • Biology & Pharmacology
    • Oncology
      • OncoCP Database
    • Pathology Core Facility
      • Histopathology
      • Molecular Pathology
    • Immunology
      • Primary immune cell assays
      • Immune cell line assays
      • Autoimmune disease models
      • In vivo PD models
      • Immune profiling for MOA
    • Tumor Immunology
    • Neuroscience
      • Volume Discount Fast services for Neuroscience
      • Behavioral Pharmacology
      • In vivo Pain Models
      • Non-Human Primate Cognition
      • In Vitro Electrophysiology
    • Cell Biology
      • Target Validation
      • Cell-based Assays
      • Cancer Cell Line Panel Screen
      • Biomarker Analysis
    • In Vitro Biology
      • Kinases
      • Epigenetics
      • GPCR, NR, Ion-channel, Transporter
      • Ubiquitin & PROTAC
      • KRAS
      • COVID-19
      • Radiometric
      • Customized assay development
      • High throughput screening
      • MOA Study
    • Metabolic & Cardiovascular Diseases
  • DMPK / Exploratory Toxicology
    • DMPK / Exploratory Toxicology
      • In vitro ADME
      • Pharmacokinetics
      • Exploratory Toxicology
      • Bioanalysis
      • Regulatory filing
    • Biomarkers, Preclinical & Clinical Sample Bioanalysis
    • Large molecule PK/BA services
      • Monoclonal Antibodies
      • Antibody Drug Conjugates
      • Bispecific Antibodies
      • Proteins & Peptides
      • Immunogenicity
  • Biologics Discovery
    • Antibody Discovery
      • Hybridoma
      • Antibody Engineering
      • Phage Display
      • Antibody-Drug Conjugate
    • Protein Science
    • Biologics Analytical Services
      • mAb Release Tests and Extended Characterization
      • Antibody-Drug Conjugate(ADC) Analysis
      • Therapeutic Protein Characterization
      • Biomolecular Interaction Analysis
    • B Cell Cloning
  • Biologics CMC
    • Stable Cell Line Development
    • Process Development
    • Formulation Development
    • Aseptic Filling and Freeze-drying
    • Drug Developability / Manufacturability study
    • Final Container Extractables & Leachables Study
    • Analytical Development and Testing
    • GMP Production
  • Small Molecule CMC
    • Process R&D Services
    • Process Safety
    • Analytical Development
    • Pre-Formulation Development
    • Formulation Development
    • ICH Stability Studies
    • CMC CTD Support
    • Manufacturing

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