BIOANALYTICAL CONSULTING
general services
We provide scientific resources to meet your bioanalytical needs. We will you develop a bioanalytical program for your drug candidate, serve as a liaison between your company and a bioanalytical lab. We have worked with many US and International bioanalytical labs, both as client partners and Client. Experience working with various bioanalytical groups, developing bioanalytical assays based on FDA guidance and white papers. This includes development and validation of GLP bioanalytical assays Analysis of ultra-low (<0.03 mL) sample volumes and Novel biological matrices (e.g. dried matrix spots)
Services include
- Determine the linear dynamic range of the assays (LOQ, HLQ, dilutions)
- Provide method troubleshooting services as needed,
- Monitor and review method validation and sample analysis activities
- Verify that methods and data are scientifically sound and accurate, a
- Make sure necessary regulatory requirements have been met.
- Help you identify a suitable bioanalytical CRO partner.
- Perform pre-qualification audits
- Monitor and troubleshoot ongoing projects,
- Audit final study data to ensure that bioanalytical methods, processes and data generated from the laboratory will be suitable for regulatory submission.
Bioanalysis for Small Molecules
Extensive expertise in bioanalytical assay development and validation quality control based on FDA guidance.
Services
• Method development, GLP validation, and transfer
• LC/MS/MS (HPLC, UPLC, on-line SPE), HPLC/UV, and HPLC/FL techniques
• Early discovery bioanalysis, GLP sample analysis, clinical sample analysis, and high-throughput bioanalysis
• Preclinical and clinical pharmacokinetic analysis and reports
Immunoassays
• Development, GLP validation and transfer of immunoassay methods for antibody, protein and peptide therapeutics
• MSD or ELISA immunoassay development and kit validation
• Automated ELISA sample analysis using Tecan EVO liquid handling platform
• Preclinical and clinical pharmacokinetic analysis and reports
Bioanalysis for Macromolecules
• Immunogenicity testing
• Neutralizing antibody assays
• Enzymatic activity assays
For CRO/Lab Clients, we have provided scientific/technical expertise and training to improve assay ruggedness and increase laboratory efficiencies, provided data review and experimental designs to troubleshoot method development, validation, sample analysis, stability and ISR issues, prepared method development strategies for selected drug candidates, reviewed and revised SOPs, optimized laboratory and business processes, prepared report templates and provided report writing services.
OTHER TECHNICAL SERVICES for LABS include
- Bioanalytical method development and validation for drugs and metabolites
- Method transfers and partial validations
- Develop and implement method development strategies
- Provide remote or on-site bioanalytical expertise to US and International Clients
- Determine the root cause for assay issues observed during method development, method validation or ISR, and identify suitable solutions
- Identify and minimize potential LC-MS/MS matrix effect issues
- Evaluate, recommend and implement strategies for new technologies and automation
- Review and critique assay methodology and validation data
- Develop and present targeted scientific seminars and training programs