Analytical Advantages

Our comprehensive range of analytical services supports all of the key activities through the drug development process of your product.

Our Quality Control department uses a range of analytical techniques to define the high order structure of your protein. We can set quality critical attributes, and characterize your protein to enable high concentration formulations.

We offer:

  • Analytical development packages supporting the development or refinement of the manufacture
  • Design, testing and validation of cleaning methodologies
  • Development, qualification and validation of test methods
  • Characterization of proteins, polypeptides and reference standards
  • Design and execution of comparability studies
  • Design, execution and reporting of forced degradation programs
  • Design of stability trials, storage and execution for drug substance, product and placebo materials
  • Production and aliquotting of reference standard material

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