Method Validation for Total Protein Quantification in Keratinocyte Cell lysate using Bicinchoninic Acid Assay
Program: Applied Biotechnology Master's Degree — 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.