Analytical Method Development, Assay Verification, and Characterization Capabilities
Assay verification is the necessary first step in any analytical method qualification or validation. It ensures that an assay can be successfully performed by GBI on an eventual cGMP scale from a method tech developed in-house or transferred from an outside lab.
GBI’s protein characterization team provides bioanalytical method development and assay verification services that follow current USP/EP guidance. These services are offered for a wide range of therapeutic products such as monoclonal antibodies (mAb), fusion proteins, bispecifics, antibody-drug conjugates (ADC), and many more.
The Importance of Analytical Method Development and Validation
Analytical method development and validation is essential to measure levels of a drug (pharmacokinetics) in human serum, as well as to detect neutralizing antibodies typically generated by a patient’s immune system against a protein-based drug during the clinical trial.
Analytical methods to ensure safety, purity, and efficacy of the drug candidates during the manufacturing process must be qualified during the drug development process before entering clinical trials.
GBI’s Testing, Assay Development, and Validation Methods
GBI provides a full array of routine testing, biologics assay development, and validation of cell-based assays for monoclonal and polyclonal antibody characterization as well as to characterize recombinant proteins, fusion proteins, antibody drug conjugates, and vaccines:
- HPLC: Reverse Phase, Size Exclusion, Ion-exchange, Hydrophobic (HIC), Hydrophilic (HILIC)
- ELISA (potency, host cell proteins, residual contaminants, immunogenicity)
- Gel electrophoresis (SDS and IEF)
- Capillary electrophoresis (CE, SDS, and icIEF)
- Western blot analysis
- Protein concentration (UV, colorimetric, fluorescent, luminescent)
- Fluorescence spectrometry
- Measurement of the ratio of protein to a chelating agent, drugs, dyes, and/or ligands (for bioconjugation processes)
- Octet (binding kinetics and concentration of antibodies in cell culture harvest) or Protein A HPLC for product titer
- Cell-based assays (potency)
- Identification of raw materials per USP and EP monographs
- Pharmacopeial testing (including pH, osmolality, conductivity, extractable volumes, appearance, A280nm, and bioburden)
- Design of assay control strategy, specifications, and assay troubleshooting
- Product stability studies including in-process intermediate hold stability (during purification), freeze-thaw stability, limited or extended forced degradation stability, and pre-formulation buffer stability studies
- Method transfer and development/optimization