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State-of-the-Art Equipment and Methods

Within the broad range of services provided by our analytical laboratories and expert teams, specialized equipment and methodologies are used to ensure product quality and to verify processes across all stages of drug product development (DPD). Adhering to quality by design principles (QbD), product and process analysis is performed using our state-of-the-art instruments to ensure optimal formulations and manufacturing processes while further mechanical testing and other analytical methods are used to verify function of vials, pre-filled syringes (PFS), autoinjectors (AI), and other combination products.

High-throughput and Automation Instrumentation supporting Formulation and Process Development

  • MFI – sub visible particles
  • HIAC – sub visible particles
  • Flex-P – automated visible particle imaging system
  • FTIR microscope – particle identification
  • DLS – nano scale size distribution
  • DLS plate reader – high throughput testing of size, Tagg and Kd
  • Freeze-drying microscope – Tc for lyophilization cycle development 
  • mDSC – Tg’
  • PEAQ DSC & VP DSC – conformational stability evaluation
  • cIEF – charge heterogeneity testing
  • Material tester – break-loose force, gliding force, cap removal force
  • Rheometer – viscosity and rheology
  • Uncle – all-in-one stability screening
  • Force tensiometer – surface tension related measurement
  • Microfluidic modulation spectroscopy – secondary structure analysis
  • Image Dimension Measurement System – for PFS
  • Densitometer – density measurement
  • HPLC / UPLC – SEC, CEX, RP analysis 
  • High throughput work station for buffer exchange
  • Automated sample preparation and testing system
  • High throughput protein quantification system – testing of concentration and turbidity
  • CG-MALS – mechanism of aggregation and nucleation 
  • Freeze / thaw system – freeze & thaw process development and stability studies using a minimal amount of product
  • Microfluidizer – nanocrystalline / nanoparticle / nanoemulsion formation
  • Headspace analyzer – container and closure integrity testing
  • Silicone oil distribution analyzer – for PFS
  • Microfluidizer Processor – for nanoparticle
  • Nano Liposome Extruder – for nanoparticle
  • Low Field Nuclear Magnetic Resonance – moisture content and protein concentration

In addition to DPD, our analytical testing teams provide the entire spectrum of analytical development services (biochemical, biophysical, physicochemical, biological and compendial assays), and biosafety testing to support our biologics discovery R&D teams and CMC development processes. Go here to see the full range of our comprehensive analytical capabilities or contact us to learn more