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Process Safety

Home Small Molecule CMC Process Safety

Process Safety

Process Safety & Hazard Assessment is a vital aspect of development. We have an experienced and dedicated team responsible for process safety and hazard assessment evaluation. The team performs process hazard analyses and preliminary hazard and operability studies for every manufacturing step prior to scale up in the Kilo-Lab and Pilot Plant. Key equipment includes calorimeters and Differential Scanning Calorimetry (DSC) in our process safety evaluation lab.

The calorimeters (Mettler-Toledo RC1e and Syrris Atlas) are used for reaction characterization, which helps identify key process parameters, including Reaction Enthalphy, Thermal Conversion Rates, Maximum Temperature of the Synthesis Reaction (MTSR), ΔTad (Adiabatic temperature rise), gas evolution, and others. The DSC measures the enthalpies associated with transitions and chemical reactions and determines the temperature at which these processes occur. Combining these tools enables the chemists and process engineers to develop robust, safe manufacturing processes and ensure products are manufactured safely.

  • Service Overview
  • Discovery Chemistry
    • Synthetic Chemistry
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    • 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
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      • Primary immune cell assays
      • Immune cell line assays
      • Autoimmune disease models
      • In vivo PD models
      • Immune profiling for MOA
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      • 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
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      • Monoclonal Antibodies
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      • 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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