Quality Control Testing

Expert Driven Drug Development

Comprehensive Testing to Ensure the Quality, Safety, and Consistency of Your Cell and Gene Therapy

State-of-the-art methods and a diverse range of advanced analytical technologies are hallmarks of Landmark Bio’s Quality Control (QC) testing services. Designed to support clinical studies through commercialization and to ensure product Identity, Purity, Potency and Safety, Landmark Bio’s QC laboratories and services support a broad range of analytical platforms.

  • DNA/RNA quantitation with ddPCR and qPCR platforms
  • Automated cell counters (e.g. Vi Cell Blu and NC202)
  • BSL2 level cell culture for bioassays
  • Quality-controlled protein analysis with multi-mode approaches
  • ELISA plate reader (luminescence, absorbance, fluorescence)
  • Automated imaging and documentation for protein/DNA/RNA gel electrophoresis and western blotting
  • Sensitive purity analysis with ultra HPLC (Agilent)
  • Flow Cytometry (Beckman Coulter)
  • UV/Vis Spectrophotometer (Thermo Fisher Scientific) and NanoDrop
  • Visual Appearance Light Box
  • Rapid safety tests with Sterility (BioMerieux BacT), Endotoxin (Charles River EndoSafe MCS), Bioburden, and Gram Stain.
  • pH and Conductivity measurement

Rigorous Quality Control Testing

Leveraging a comprehensive battery of QC testing methods, Landmark Bio ensures the quality, safety, and consistency of your cell and gene therapy through the implementation of rigorous QC measures, including:

  • Method qualification
  • Method validation
  • Safety testing
  • Full release testing
  • In-process testing
  • Stability testing

Quality Control Laboratory Designed and Built for Cell and Gene Therapy Testing

Landmark Bio’s QC Laboratory was built and designed to accommodate the requirements of Advance Therapy testing. Utilizing 21CFR part 11 compliant software, the space includes segregated rooms for PCR (qPCR, ddPCR) and microbiology testing, and a comprehensive array of instrumentation to support product testing and release, including: automated cell counters, particle counters, flow cytometers, spectrophotometers, HPLC, multi-parametric plate readers, and BACT/ALERT rapid sterility instrument.

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