Preclinical Pharmaceutical

Preclinical Pharmaceutical Capabilities

Current Capabilities:

  • Process and Formulation Analysis:
    • Process and Formulation Analytical Methods Development
    • Drug Substance HPLC Purity Profiling, Stability Indicating Method Development
    • Method Validation under GLP per FDA-CDER and ICH Regulations and Guidelines
    • QA Phase Inspections and Data Review
    • DS and Drug Product (DP) Impurity Identification and Characterization
    • Stability Studies for DS/API (12-24M)
    • DS and Analytical Reference Standard (ARS) Characterization
    • GC Residual Solvent Analysis
    • Issuance of Certificate of Analysis (COA)
    • DP HPLC Purity Profiling, Stability Indicating and Assay Method Development
  • Bioanalysis Studies:
    • LC/MS and CE/MS method development
    • Method validation for drugs/metabolites per FDA or ICH
    • Quantitative bioanalysis of preclinical and early clinical samples
    • COA and recertification for test substances, reference and metabolite standards
    • Metabolite profiling for cold and C-14 labeled compounds, ID and characterization
    • Metabolite isolation/enrichment by fraction collection, prep and/or semi-prep columns
    • Quantitation of test article and metabolites
  • Metabolism Studies:
    • in-vivo analytical ADME services and in-life phase through a partnering company
    • in-vivo study types include mass balance, tissue distribution, metabolite profiling / radio profiling and ID, discovery PK, formulation bioavailability screening and cassette PK
    • in-vitro metabolism studies with pooled liver microsomes, hepatocytes and S9 fraction
    • Interspecies comparisons in mouse, rat, dog, rabbit, pig, monkey and human
    • P450 isozyme phenotyping
  • Other Services:
    • Non-Clinical Pharmacological and Toxicological studies
    • DP Extractable and Leachable Studies
    • Dissolved O2 Analysis in DP
    • Small-scale, in-house, non-cGMP Drug Substance (DS) Synthesis
    • ARS Synthesis
    • Large-scale Synthesis Support at Manufacturing Sites
    • Developing DS and DP Specifications
    • Process Scale-Up Transfer to Manufacturing Sites
    • Product Chemistry (i.e. physical/chemical chracterization, storage stability analysis, etc.)
    • Particle Size & Surface Characterization: Particle surface, shape and area calculation by Light Microscopy Technique utilizing powerful computer software and digital camera/video
  • Pharmaceutical aNDA Capabilities for Oncological Agents:
    • USP methods Transfer and Validation
    • Formulations Development
    • Formulation Stability Studies
    • Specification
    • Drug Substance and Drug Product Manufacturing Support
  • Regulatory Capabilities:

    We are experienced in the following areas of IND Submissions for Oncological Agents:

    • Preparation of CMC Dossier
    • Preparation of Toxicology Section
    • Preparation of Metabolism
    • Bioanalytical and PK Sections

Near-Future Capabilities:

  • DP Development including Liquid and Gel Formulations
  • Patent Search