New York – Jun 29th, 2018 – Creative Proteomics, the world’s leading proteomics products and service provider, released the launch of professional host cell protein analysis service which can help detect and characterize the HCP in order to identify and quantify HCP in the development of biopharmaceutical products to ensure the purity of products. The methods Creative Proteomics offered include immune-specific methods such as Western blot, ELISA, or non-specific methods such as electrophoresis and MS, all these enhance the capability for sample purification and batch release.
At present, an increasing number of drugs entering the market are proteins rather than small molecules, most of which are produced with the host cell system. Host cells express many of their own proteins and can easily contaminate recombinant protein drugs. The application of biological systems to synthesize complex protein drugs has achieved significant success. However, it is becoming more important to analyze and clear undesired proteins in host cells. During the production of protein drugs, the levels of these HCPs must be significantly reduced to ensure that these potential antigenic impurities are eliminated or reduced to levels that will not result in immune responses.
In general, the most commonly used method for detecting and measuring HCP during biological processing manufacturing is an immunoassay, such as an enzyme-linked immunosorbent assay (ELISA) which is a method based on polyclonal antibodies produced by host cells for the synthesis of a particular therapeutic product. ELISA has been used as the main method for HCP detection due to its high throughput, high sensitivity and selectivity features. However, ELISA cannot fully identify all HCP species so that it is particularly important to ensure that weak and non-immunoreactive HCPs will not be ignored.
Mass Spectrometry (MS), as the main alternative analytical technique to ELISA, which function is to monitor and identify multiple protein analytes in the same sample in a high-throughput manner quickly and efficiently. Besides, MS can detect few amounts of HCPs that will affect the drug product or cause immunogenicity. Mass spectrometry can not only monitor and measure the host cell protein and product impurity spectrum, but also identifies the presence and absence of any sample, including low-abundance proteins. Therefore, the combination of liquid chromatography and tandem mass spectrometry (LC-MS/MS) is now widely used for rapid monitoring of HCP.
Besides, combining mass spectrometry with ‘data-independent’ SWATH analysis that allows MS/MS analysis to be performed on a small mass window. The SWATH analysis will collect data for all content, which means that if a sample is run multiple times, the retrieved data will always be the same. This ability to generate reproducible data is critical to drug development research. A quadrupole time-of-flight MS/MS instrument with the SWATH acquisition will quantify and confirm the digital record of all the substances in the sample, thereby quantifying and confirming all HCP contaminants in a sample.
Host cell proteins form a major part of process-related impurities and may have an adverse effect on drug safety, leading to the importance of accurate identification and quantification. With the simultaneous classification and quantification of all residual background proteins, improved product quality, and time savings, mass spectrometry may become the gold standard for future HCP analysis.
About Creative Proteomics
Founded in 2005, Creative Proteomics provides customers with innovative host cell protein analysis for HCP identification to greatly avoid the contamination in order to enhance the drug safety. Creative Proteomics is well-recognized proteomics industry leader with more than 10 years experiences, million active users all over the world.
Company Name: Creative Proteomics
Contact Person: Melissa George
Email: Send Email
Address:45-1 Ramsey Road
State: New York
Country: United States