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Life Sciences

Method Development and Validation

Pace Analytical Life Sciences (PLS) provides method development and validation services on biological therapeutics. 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 determination of physical and chemical degradation. PLS employs a variety of chromatographic techniques as part of our biologics service offerings including the following:

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

Other techniques commonly validated to characterize and establish stability of biological therapeutics include:

  • Isoelectric focusing (IEF) and capillary isoelectric focusing (cIEF) separates peptides and proteins based on their overall charge, specifically their isoelectric point, and is used for identity confirmation and as a highly sensitive stability indicating method.
  • SDS-PAGE is a technique used to perform 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 a differentiation can be made between covalent and non-covalent aggregates, as well as clipped species.
  • 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) are established and performed for potency assessments.

PLS maintains 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.