Case study

How to monitor impurities and ensure consistent therapies

Oct 2021, by Ejvind Mortz

FDA questions about impurities

There are instances when commercial or custom ELISAs may not be sufficient for measuring HCP impurity levels:

  • Sometimes, finding an ELISA covering all process-related proteins in the cell or gene therapy may not be possible.
  • The coverage of your ELISA may be lower than acceptable. For instance, when the proteins originate from different sources, e.g., HEK and bovine.
  • The ELISA manufacturer ran out of antibodies earlier than expected.

Luckily, mass-spectrometry analytics can address such problems, it is customizable and can be used for all types of expression systems and samples.

What we'll cover:

  • How to live up to the impurity guidelines from the FDA and EMA
  • Identify and quantify all individual proteins – to low-ppm levels
  • Examples of  data results from an MS-based analysis

Talk to us

Whatever protein-related challenge or question you may have, we would love to help. Our experts can help you decide on the best analytical approach for your project by email or online meeting - providing advice without obligation.

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