Analytic

Particle Sciences Analytic Services group is exceptionally qualified to handle our client's needs. Analytic Services has four divisions: Physical Characterization, Bioanalytic, Analytic Chemistry and Biopharmaceutical Analysis. These groups support our formulation division and also perform standalone work. All groups operate under GLP/cGMP. We are FDA registered and DEA licensed for all schedules of controlled substances.

The work in Analytic Services ranges from early method development through and onto validation and clinical and commercial support. With decades of experience, our staff will help you design and successfully execute a phase-appropriate analytical strategy.

We are world leaders in the physical characterization of pharmaceutical formulations. Our facility is one of the best equipped in the US and we are uniquely capable of supporting the development and registration of drug products based on particulates, semisolids and devices.

The Biopharmaceutical group works with bio-therapeutics and vaccines ranging from therapeutic proteins, including monoclonal antibodies, to nucleotides, to vaccine antigens and immunomodulators. To support these development and manufacturing activities, Particle Sciences runs the full gamut of testing including, among others, ELISA, SDS-PAGE, Western blots, image analysis, HPLC, LC, LC-MS, ligand-receptor binding assays, cellular proliferation, cytotoxicity and cellular activation assays. These analytic methods are used to assay the biological products being formulated and to measure the in vitro potency of the final product formulations.

Services include:

  • Analytical method development and validation
  • LCMS API and related substances characterization
  • Physical characterization (particle / nanoparticle)
  • Compatibility studies
  • Forced degradation studies
  • In-vitro release studies
  • Antibody based biological product detection and quantitation assays: ELISA, Fluorescence binding and Western blots
  • Ligand-receptor binding and competitive inhibition
  • In vitro potency analyses using cellular proliferation, activation, and cytotoxicity assays
  • Biopharmaceuticl characterization, sizing and stability
  • ICH and custom stability studies
  • GMP batch QC-release testing
  • Development of stability indicating methods, photostability, accelerated and long-term stability programs

Analytics and Characterization Equipment:

  • HPLC, UPLC
  • LC/MS ion trap
  • LC/MS triple quad
  • NMR, SEM, XRD by third parties
  • UV/VIS
  • UV/VIS Plate Reader
  • Plate washer
  • SDS-PAGE and Western blotting
  • Gel imager and analyzer
  • Cell culture facility
  • FTIR
  • Differential scanning calorimetry
  • Thermogravimetric analysis
  • Microscopic image analysis
  • Fluorophotometer
  • Percutaneous absorption (IVRT) using Franz diffusion cells
  • ELISA and fluorescence binding assays using a plate reader
  • Cellular proliferation and activation assays
  • SDS-PAGE and Western blots using an imager/analyzer
  • Gel electrophoresis particle size via dynamic light scattering (DLS)
  • Particle size via laser diffraction
  • Particle size via X-ray disc centrifuge
  • Particle charge (zeta potential) by electrophoretic light scattering
  • Sotax CE7 Smart USP Dissolution Apparatus 4 Flow Through Cell
  • Particle charge (zeta potential) by phase analysis light scattering
  • Rotational rheometry
  • Squeeze flow rheometry
  • Tensile and tack testing
  • Dynamic contact angle
  • Surface tension
  • Turbidity
  • Osmolality
  • Contact angle/surface energy measuring system
  • Sedimentation-stability analyzer
  • HPLC with ultraviolet, photo diode array, evaporative light scattering detectors
  • UV/VIS spectrometer
  • ICH temp/humidity stability chambers
  • ICH photostability chambers
  • Horiba Raman/particle characterization system