Protein Drug Conjugates

Pace Analytical Life Sciences (PLS) offers GMP testing services to support the growing market of targeted therapeutics, which include antibody-drug conjugates (ADCs) and polymer-drug conjugates. These therapies combine the targeting specificity of monoclonal antibodies (mAbs) with the highly potent cytotoxic properties of small molecules for the treatment of cancer. Our team maintains extensive experience with both small molecules and biologics, along with our extensive selection of testing equipment, we are able to offer the services and expertise to support the development, commercialization, and release of targeted therapies.

Drug Substance and Finished Product Support

  • Enzymatic Activity
  • Charge Variant Analysis (Capillary)
  • Size Separations (Gel and Capillary techniques)
  • Chromatography (Size Exclusion, Ion Exchange, Reverse Phase)
  • Binding and Potency ELISA
  • Concentration Determination (UV-Vis Variable Pathlength)
  • Particulate Analysis, USP <788> (HIAC ROYCO liquid particle counting system)
  • Impurities 
  • Quality Control Release Testing
  • Drug Substance and Formulation Stability Testing
  • ICH Stability Storage

Research and Development

  • Method Development
  • Method Qualification
  • Method Validation
  • Method Transfer
  • Extractable / Leachable Studies
  • Container / Closure Tests
  • Elemental Impurities (ICP-MS, ICP-OES, AA)

Raw Materials Testing

  • Formulation Excipients
  • Active Pharmaceutical Ingredients (API)
  • Compendial Methods (USP / EP / JP)
  • Vendor Qualification Program Support