During her years in the biopharmaceutical industry, Carol performed method development and validation work including experimental steps and observations recorded in laboratory notebooks. Based on these laboratory notes and to fulfill FDA and industry requirements, Carol wrote formal reports describing and evaluating the development and validation work. They were archived at the facilities where the work was done and used for reference when developing documents to support quality control testing.
The writing sample is from a validation report on the analysis of a chimeric protein consisting of a diphtheria toxin and a second polypeptide sequence that had affinity for cancer cells. This fusion protein was a unique construction composed of two biologically active parts that would not normally be found within the same protein complex.