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
  • Confocal Microscopy
  • Microinjection
  • Peptide Map
  • LC/MS and LC/MS/MS
  • pH
  • 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 BioAnalytical 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