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On-site labs with our own personnel offer greater control of samples and timelines, minimizing risk for our customers.
Full cGMP quality control analysis of clinical and commercial products is done by our in-house staff. With well-equipped, on-site analytical and microbiological laboratories as well as stability chambers, our scientists monitor end-to-end processes to confirm the safety and quality of each batch.
We implement a system-wide QbD approach to different phases of a clinical or drug product including raw materials, in-process, batch release, and stability / shelf-life evaluation.
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Analytical Development

  • Early tech transfers without pre-approved protocol
  • From scratch method development and redevelopment
  • Formal method transfers with protocol
  • Method validation
  • Experience with hard-to-analyze sample matrices (viscous, reactive, limited stability)
  • Pre-GMP and GMP-level testing

Testing Capabilities

  • Sterility (state-of-the-art isolator technology)
  • Bacterial endotoxins
  • Culture purity
  • Microbial enumeration / titer
  • Culture media growth promotion
  • Imaging microscope
  • Comprehensive cleanroom support
  • Gas chromatography (GC)​
  • HPLC / UPLC – including UV/VIS, PDA, RI, ELSD, MS, MALS​​
  • Capillary electrophoresis​
  • SDS-PAGE gel electrophoresis / Western blot​
  • FT-infrared spectroscopy (FT-IR)​​
  • UV-visible spectroscopy (standard and variable path length)​
  • Osmometry​​
  • pH​
  • Conductivity​​
  • Near-infrared spectroscopy (NIR)​​​
  • Titration​
  • Karl Fischer​
  • Total organic carbon​
  • Custom dissolution​
  • ELISA / multi-modal plate reader​
  • Raman spectroscopy
  • Rotational viscosity​​
  • Rheometry​
  • Differential viscosity​
  • Polarimetry​​
  • Density​
  • Extrusion force​​
  • Delivered volume / volume in container​​​
  • Turbidity​​
  • Leak detection​​​
  • Refractive index​​​​
  • Liquid particle counting – light obscuration and microscopic​

ICH Stability Studies

We have extensive experience performing ICH-compliant stability studies for early-to-late stage drug product development programs over multiple years.

  • Deep understanding of regulatory requirements
  • Collaboration on study design
  • Rapid data turnaround
  • Strong data integrity   

Capabilities

On-site stability chambers
  • On-site stability chambers
  • 5°C walk-in
  • -20°C walk-in
  • 25°C/60% RH walk-in
  • 30°C/65% RH walk-in
  • 40°C/75% RH walk-in
  • Multiple configurable reach-in chambers
  • Chambers are validated, routinely maintained, and continuously monitored / alarmed
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Sodium Hyaluronate

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