BioTechLogic’s analytical team has hands-on experience performing and developing methods.
BioTechLogic will provide hands-on or consultancy services for analytical 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.
- HPLC (RP, IEX, SE, and HIC) using UV, fluorescence, ELSD, RI, and PAD detectors
- UV/Visible spectroscopy
- SDS-PAGE, CE-SDS
- Peptide Mapping
- LC/MS, LC/MS/MS, and GC-MS
- ICP-OES, and ICP-MS
- pH, Osmolality, and Visual Inspection
- Isoelectric Focusing (IEF)
- Dynamic Light Scattering (DLS)
- Flow Cytometry
- Western Blot
- Circular Dichroism
- Differential Scanning Calorimetry
Additional practical knowledge and method development support includes, but is not limited to, Kinetic Assays (both endpoint and time course assays; cuvette and plate based), HCP (ELISA kit and MS-based), LAL, DNA Threshold, Differential Scanning Calorimetry, Capillary Electrophoresis (CE), Bioburden, Polymerase Chain Reaction (PCR), droplet digital PCR (ddPCR), infectious titer assays, replication-competent AAV (rcAAV) assays, bioassays, gene expression assays, functional potency assays, post-translational modification analysis, amino acid analysis, and analytical ultra-centrifugation (SV-AUC)
Examples of our Analytical Services:
- Strategies for method qualification, verification and validation, stress stability/forced degradation study design and execution, including oxidation and photostability evaluation
- 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
- Analytical similarity assessments
- Reference standard and stability program design
- Characterization study design
- Assisting with the development of phase-appropriate analytical strategies
- SOP generation and compliance support
BioTechLogic has also managed third-party laboratories during the development, qualification, validation, and transfer of residual, impurity, assay, content, potency, and safety methods. We have also managed multiple method transfers of qualified and validated methods from contract laboratories to manufacturing sites.