Preclinical Pharmaceutical Capabilities
Current Capabilities:
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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
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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
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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
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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
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Pharmaceutical aNDA Capabilities for Oncological Agents:
- USP methods Transfer and Validation
- Formulations Development
- Formulation Stability Studies
- Specification
- Drug Substance and Drug Product Manufacturing Support
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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