BioAnalytical Services
BioTechLogic will provide hands-on or consultancy services for methods that require development, qualification or validation and are intended to be used in the support of characterization, profiling, validation or product release activities for intermediates, drug substance or drug product.
In addition, we will provide guidance on analytical method validation activities to ensure compliance with current industry and regulatory standards.
BioTechLogic's BioAnalytical staff has hands-on method experience in:
- HPLC (RP, IEX, SE, and HIC) using UV, fluorescence, ELSD, RI and PAD detectors
- UV/Visible spectroscopy
- SDS-PAGE
- Western Blot
- ELISA
- Kinetic Assays (both endpoint and time course assays; both cuvette and plate based)
- Confocal Microscopy
- Microinjection
- Peptide Map
- Circular Dichroism
- LC/MS and LC/MS/MS
- MALDI-TOF
- pH
- HCP (kit)
- Isoelectric Focusing (IEF)
- LAL
Additional practical knowledge resides in DNA Threshold, Differential Scanning Calorimetry, Capillary Electrophoresis (CE) and Bioburden.
Examples of Our BioAnalytical Services:
- Strategies for Method Qualification, Verification and Validation
- Analytical Method Development and Transfer
- On-Site Method Development Troubleshooting
- CMC Submission Summaries for Analytical Method Description and Method Validation
- Process Impurity Profiling Studies
- Residual Removal Studies
- Cell Banking and Stability Studies
- In-Process Hold Time Stability Studies