The biotherapeutic QC testing department at Luina Bio is responsible for the sampling, management, and testing of a wide range of materials including raw materials, in-process samples, drug substance samples, drug product samples, stability samples, and environmental monitoring samples.

Luina Bio’s QC staff are highly trained in state-of-the-art analytical techniques.

Our analytical capabilities include:

  • Protein Biochemical Analysis
    ELISA Testing Service (incl. fluorescence detection)
    Host Cell Protein Testing
    Fluorescence/Luminescence/Absorbance spectrophotometry
    SDS PAGE/Western Blot
  • Chemical and Physicochemical Techniques
    HPLC (UV/PDA/ELSD)
    UV/VIS spectrophotometry
  • Anaerobic and Aerobic Bacterial Culture and Analysis
    Microscopy (Including Fluorescence – Live/Dead analysis)
  • Environment Monitoring
    Endotoxin
    Total Organic Carbon (TOC)
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The Quality Control Leaders

Luina Bio’s QC department performs two distinct functions:

  • Chemical, Biochemical, and Microbial analysis
    • This includes raw material testing, in-process/intermediate control testing, API/drug substance testing, drug product testing, and stability testing, as well as environmental monitoring testing
  • Transfer, Development, and Process Validation of analytical methods
    • These processes ensure efficient transfer of analytical methods and setup of new methods to support our client’s projects