Oligonucleotides GMP Testing

Pace Analytical Life Sciences (PLS) offers testing services to support the biopharmaceutical manufacturing industry. Our team of experts and our extensive selection of testing equipment offers you the services and expertise to support your biopharmaceutical development, commercialization, and release of marketed products.

We provide support for the development of new therapies and to ensure the quality of your marketed therapeutic proteins, synthetic peptides, enzymes, conjugates and specialty molecules:

  • Finished Product and Packaged Goods
  • 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)
  • Impurities / Degradation Products
  • Quality Control Release Testing
  • 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