Capstone Projects

Method Validation for Total Protein Quantification in Keratinocyte Cell lysate using Bicinchoninic Acid Assay

Program: Applied Biotechnology Master's — Quality Assurance and Compliance
Host Company: Stratatech -A Mallinckrodt Company
Location: Madison, Wisconsin (onsite)
Student: Michelle Menadue

The project was a method validation for a BCA method to quantify total protein concentration in a cell lysate. The method is part of a two-method process to determine cell identity in a cell banking system used in final product manufacturing. The validation followed /CH guidelines for which method characteristics were evaluated to demonstrate that the method was fit for its intended purpose. The validation met all pre­determined acceptance criteria so the method will be incorporated as written for routine testing of cell banks.