Critical Quality Attributes

The critical quality attributes are a fundamental part of any CMC drug development project. However, many young biotech companies fail to establish a CQA overview early on in development. This is not a complicated and time consuming task but simply requires that the right people with the relevant experience join forces and have a structured talk to decide on the CQAs. The CQA overview also serve as a valuable input to what type of analytical methods should be developed to support the control strategy.

In many cases the CQA list will be generic dependent on the modalities and manufacturing technologies employed. It is better to have a list early on in development which can evolve as more knowledge becomes available than having no list at all.

Below is a free template for download which would work for most injectable protein and peptide drug products and only require minor modifications to suit your project.