Nuclease-Free BSA Qualification for Use in an in-house Enzyme Activity Assay

The global supply chain has been largely impacted by the pandemic, leading to downstream material supply issues for companies like Exact Sciences. Exact Sciences manufactures and tests many products that require high-quality materials with specific requirements. Many of these materials are sourced from external suppliers and can be considered to be High-Risk Raw Materials. These types of materials are essential to the business function of Exact Sciences, further meaning that without these materials Exact Sciences could not function as a business. Bovine Serum Albumin or also referred to as BSA is a high-risk material at Exact Sciences. BSA is commonly used in many products and assays at the company to prevent unwanted protein degradation. The In-House Enzyme Activity assay requires the use of Nuclease-free BSA. Nuclease-free BSA is a type of BSA that does not contain any kinds of nucleases such as RNase or DNases. The presence of nucleases in the BSA will affect the quality and effectiveness of the assay. Nuclease-free BSA was being purchased from a supplier that recently informed Exact Sciences that they would no longer be manufacturing this product due to supply chain issues. This capstone project aimed to source and test the feasibility of two new candidate suppliers for Nuclease-free BSA. The two new candidate suppliers provided enough material to conduct a feasibility study to ensure the material performed statistically similarly to the current supplier of BSA. The feasibility study included manufacturing individual assay diluents with each supplier. Then using the newly manufactured diluent to perform the assay and compare the results produced by the new candidate suppliers to the data obtained from the current supplier.

Three BSA varieties were used throughout this capstone project. It’s intriguing how the same reagent can be physically different across different manufacturers.