A Validation Case Study Using Bovine Serum Albumin
نویسندگان
چکیده
W ith protein biologics, it is critical to accurately determine an absorptivity constant. The constant is then used when routinely measuring protein concentration by ultraviolet (UV) spectrophotometry. The yield of product during manufacture and the product content and potency on the label are dependent on this constant. There have been several approaches in the past to determining the constant, but all have drawbacks — primarily poor accuracy, or interference from excipient salts, or overly tedious methods. Our study sought to demonstrate a method for determining specific absorptivity constants (as) by amino acid analysis (AAA) that provides accurate and precise quantitation of protein A Validation Case Study Using Bovine Serum Albumin
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