Method Development

Custom Bioanalytical Method Development

Tap into our protein chemistry expertise for compliant bioanalytical method development to help move your product forward. Whether you’re developing methods for complex recombinant proteins, plasma protein therapies, or cell and gene therapies, Prolytix provides relevant, timely data for rapid tech transfer.

Our R&D services to support pre-clinical, clinical and CMC studies include characterization and comparability of biotherapeutics, anti-drug antibody assays, and more.

Our techniques and methods include

Biotherapeutics

  • Aggregation State
  • Biomarker Assay Development and Validation
  • Host Cell Protein Solutions
  • Enzyme Kinetics/Functional Assays
  • Liquid Chromatography (HPLC/FPLC)
  • Ligand-Binding Assays (LBAs)
  • Antibody Conjugation
  • Critical Reagent Manufacture
  • Quantitative Western Blot
  • SDS-PAGE/Capillary Electrophoresis (CE)
  • Charge Variant Analysis (cIEF)
  • Process Development
  • Protein Purification
  • Preclinical Sample Analysis

Immune Response

  • Anti-Drug Antibody (ADA) Assays
    • Screening Assays
    • Confirmatory Assays
    • Neutralizing Antibody Assays

Hematology

  • Clotting and Chromogenic Substrate Assays
  • Hemostatic Risk Assessment
  • Plasma Fractionation
  • Platelet Aggregation
  • Thrombin Generation Assays (TGA)
  • Thromboelastography (TEG)

Need help with a method that’s not on the list? Connect with one of our experts. With our consultative approach, we’ll find a solution to meet your needs.