Method Development and Validation

Pace Analytical Life Sciences (PLS) provides method development and validation services on biological therapeutics suitable for all stages of the biopharmaceutical product cycle. PLS specializes in the development and validation of chromatographic methods used to characterize biophysical and chemical properties during in-process and release testing. Chromatographic methods are also are common tools for the determination of physical and chemical degradation. PLS employs a variety of chromatographic techniques (via a full complement of instrumentation) as part of our biologics service offerings including the following:

  • HPLC/UPLC:
    • Reversed Phase Chromatography
    • Size Exclusion Chromatography
    • Ion Exchange Chromatography
    • Hydrophobic Interaction Chromatography
  • UPLC-MS-MS
    • Triple Quadrupole Mass Spectrometry
    • Quadrupole Time-of-flight Mass Spectrometry

PLS is staffed, equipped, and ready to provide development and validation services for other common techniques used to characterize and establish stability of biological therapeutics including:

  • SDS-PAGE is a traditional slab gel technique used to perform a size-based analysis of peptides and proteins. SDS-PAGE is an efficient stability-indicating technique that offers high specificity; various degradants can be resolved in the same gel, and differentiation can be made between covalent and non-covalent aggregates, as well as clipped species.
  • Capillary electrophoresis sodium dodecyl sulfate (CE-SDS) is the modern equivalent to SDS-PAGE with the added benefit of great reproducibility and modernized data acquisition.
  • Capillary isoelectric focusing (cIEF) separates peptides and proteins based on their overall charge and is used for identity confirmation and as a highly sensitive stability indicating method.
  • Spectroscopic techniques, such as UV-Vis (UV) and fluorescence, are used for quantitative and qualitative analysis of conformational structure of proteins.
  • Enzyme-linked immunosorbent assay (ELISA) and/or enzymatic activity assays are established and performed for potency/quality assessments.

PLS maintains the expertise to draft a custom validation protocol or will follow client-supplied protocols to comply with ICH and FDA guidelines. Our protocols are flexible enough to be customized and we work with clients to support a phased approach to coincide with your product development timeline.