Protein concentration determination is critical in the development and production of biopharmaceuticals for several reasons:
- Quality Control: Determining protein concentration is essential for maintaining the quality and consistency of biopharmaceutical products.
- Process Optimization: Knowing the exact protein concentration allows for optimization of downstream processes, leading to improved efficiency and cost-effectiveness.
- Regulatory Compliance: Accurate protein concentration determination is often required to meet regulatory guidelines and ensure product safety.
Some commonly used techniques include UV Absorbance at 280 nm and Bicinchoninic Acid (BCA) Assay. When selecting a method for protein concentration determination, several factors should be considered, including the type of sample, the sensitivity required, and the equipment available. It is important to choose a method that provides accurate and reproducible results for the specific application.
As a trustworthy CDMO company, Amaran Biotech provides quality solutions in analytical services. Recently we have developed an analytical method of protein concentration for our client. This process is challenging because the protein is only stable in certain formulations, making it difficult to test the concentration using common testing methods. Through the efforts of our staff and continuous communication with the client, a new HPLC/UV analysis method has been developed with accuracy, precision, linearity and specificity.