Accurate and Rapid Protein Concentration Measurement of In-Process, High Concentration Protein Pools

Autor: Sunitha Kandula, Nihal Tugcu, William S. McKechnie
Rok vydání: 2018
Předmět:
Zdroj: Biotechnology progress. 34(5)
ISSN: 1520-6033
Popis: Protein concentration is a critical product quality attribute and required for any therapeutic protein. Many commercial and investigational new biologics are now formulated at high concentrations (>100 mg/ml) to achieve successful subcutaneous administration. Assaying protein concentration in high concentration formulations poses a challenge, as traditional absorption spectroscopy and UPLC/HPLC (ultra/high performance liquid chromatography) assays cannot accurately measure such high concentrations without further solution manipulation. However, recent advances in UV/vis technology have led to the creation of instruments that measure samples at relatively short (
Databáze: OpenAIRE