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.
BioTechLogic’s Analytical staff has hands-on method experience in:
- HPLC (RP, IEX, SE, and HIC) using UV, fluorescence, ELSD, RI and PAD detectors
- UV/Visible spectroscopy
- Confocal Microscopy
- Peptide Map
- LC/MS and LC/MS/MS
- Isoelectric Focusing (IEF)
Additional practical knowledge resides in Western Blot, ELISA, Kinetic Assays (both endpoint and time course assays; cuvette and plate based), Circular Dichroism, HCP (Kit), LAL, DNA Threshold, Differential Scanning Calorimetry, Capillary Electrophoresis (CE) and Bioburden.
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 Development Expertise
BioTechLogic has experience developing analytical methods for proteins and macromolecules, as well as gene and cell therapies. Our process characterization and validation expertise enables us to integrate the role analytics plays in biopharmaceutical manufacturing. BioTechLogic has hands-on experience developing:
- Molecular PCR and quantitative PCR
- Sterility, bioburden and mycoplasma
- DNA extraction
- HPLC methods
- Physiochemical methods
BioTechLogic has also managed third-party laboratories during the development, qualification, validation, and transfer of residual, impurity and safety methods. We have also managed multiple method transfers of qualified and validated methods from contract laboratories to manufacturing sites.