The Quality Control (QC) department at LuinaBio 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. LuinaBio’s QC staff is trained in state-of-the-art analytical techniques.

Our analytical capabilities include but not limited:

  • Protein Biochemical Analysis;
    ELISA (incl. Fluorescence detection)
    Fluorescence spectrophotometry
    SDS PAGE/Western Blot
  • Chemical and Physiochemical Techniques;
    HPLC (UV/RI/PDA/ELSD)
    Capillary Electrophoresis
    UV/VIS spectrophotometry
  • Anaerobic Bacterial Culture and Analysis;
    Microscopy (/Fluorescence)
  • Environment Monitoring;
    Endotoxin
    TOC

LuinaBio’s QC department perform two distinct functions:

  • Chemical, Biochemical analysis. This includes raw material testing, in-process/intermediate control testing, bulk drug substance testing, drug product testing and stability testing (available onsite chambers range from 40℃/75%RH to -80℃).
  • Transfer and Validation of analytical methods. This ensures efficient transfer of analytical methods and set-up of new methods to support our client production processes.

All instruments LuinaBio employs are validated according to current guidelines (including ICH) and the methods of analysis meet all international requirements and will be qualified / validated as appropriate for the specific product development stage. Our analytical methods are verified under actual conditions of use and documented as per regulatory guidelines and industry standards.

Our policies and procedures have been through a rigorous process of development, and you can be assured that your product is being tested under the most appropriate conditions and report data with confidence in its integrity. LuinaBio staff are continuously looking at ways to improve our systems. Drawing on more than 30 years of experience, LuinaBio scientists have the training and expertise to deliver a successful outcome to any project, with the appropriate documentation, method development (where required) and validation to support all aspects of QC testing.