After years of biotech product development, accurate protein quantification remains a challenge. Several methods exist (LC-MS/MS, immunoassay, CE or UHPLC) but require calibration with a protein standard, usually not available. AAA is probably the most commonly used method: there is no need of a reference protein but hydrolysis and derivatization result in low precision and accuracy. Quality Assistance has validated an isotope dilution ICP-MS method, based on sulfur determination, capable to quantify a protein without any specific reference substance but with very high accuracy (< 2% bias) and precision (< 1 % RSD).
No calibration necessary, no reference protein needed!
Methods with such performance will accurately determine the content of formulated biological active substances or protein standards and hence lead to much better characterization of protein-based products.
What will you learn?
- The principle of isotope dilution for sulfur determination and protein quantification
- The advantages of using the ICP-QQQ 8800 technology for this purpose
- The development steps, validation results and demonstration of the very high accuracy (< 2 % bias) and precision (< 1 % RSD) of the method
- The scope of application of the method
Who may this interest?
- Scientists engaged in the development process of proteins, mAbs, ADCs and peptides
- Analytical R&D, stability, quality control lab directors, managers, scientists engaged in characterization and quantification of biomolecules
- Process development managers and people responsible for quality by design
- Regulatory Affairs (CMC, CTD Module 3)
Philippe De Raeve is one of the founders of Quality Assistance, a Contract Research Organization offering a wide range of analytical services to Pharmaceutical companies. For more than 30 years, he has worked as Scientific Director, supervising the development and validation of hundreds of analytical methods, including GC, HPLC, UPLC, LC-MS and more recently ICP-MS. As a company, Quality Assistance often faces the problem of protein concentration determination without an available reference substance. In order to address this, Philippe developed a fast and accurate method capable of replacing the lengthy and inaccurate amino acids determination after hydrolysis.
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