Characterisation of Host-Cell Proteins using Mass Spectrometry Enables Effective Purification Optimisation


31st October 2017 | 10 AM ET | Dr Li Zang of Biogen |ATTEND FREE WEBINAR

Common mammalian cell lines used for biopharmaceutical production include Chinese Hamster Ovary (CHO), NS0 and Human Embryonic Kidney (HEK) cells. Each of these cell lines has been found with over 20,000 genes coded in their genome, which can result in over 10,000 proteins expressed at the same time in these cells. These proteins can be secreted from the living host cells or released to the cell culture supernatant upon lysis of the host cells during the cell culture. Biopharmaceuticals produced using these cell lines can be co-purified with a subset of the host-cell proteins (HCPs) in the cell culture supernatant.

These co-purified HCPs are considered process-related impurities for biopharmaceuticals. The HCPs can cause potential safety risks by introducing anti-HCP response in the patients. Depending on the biological functions of the residual HCPs, other potential impacts reported include lowering the biopharmaceutical protein stability and affecting the efficacy of the biopharmaceutical protein by exacerbating the symptoms.

Presented by Dr Li Zang of Biogen

Dr. Li Zang is a Senior Scientist overseeing the protein characterization and mass spectrometry group in the Analytical Development department of Biogen (Cambridge, MA). She obtained her Ph.D. from Northeastern University, specializing in development and application of highly sensitive liquid chromatography technology in combination with mass spectrometry for breast cancer biomarker discovery. After joining Biogen in 2005, Li developed her expertise in biopharmaceutical development especially detailed protein structure characterization using separation and mass spectrometry. She has participated in the development of a large category of biopharmaceutical programs at Biogen over the last 10 years, including monoclonal antibodies, receptor-Fc fusion proteins; blood coagulation factors, bi-specific antibodies, antibody-drug conjugates, biosimilar programs and small endogenous proteins.

 

Sponsored by SCIEX

SCIEX is a global provider of innovative LC-MS, capillary electrophoresis, and data processing technologies that assist you in dealing with biotherapeutic complexity during drug discovery, development and beyond. SCIEX innovation can help you to speed routine tasks as well as simplify your most complex characterization challenges, to achieve insights faster and with greater confidence than you ever thought possible.

 

Robust and Sensitive Host Cell Protein Detection with Unbiased SWATH® Acquisition

Rapid identification and quantification of HCPs remains a challenging endeavor as HCP levels are far lower than that of the biotherapeutic product. Currently many groups look to ELISA assays to determine total HCP concentration in their samples. However, there is a push to utilize mass spectrometry methods for HCP analysis because it allows for individual HCPs to be identified and quantified, improving the sensitivity and specificity of the analysis. Detailed LC-MS analysis helps ensure problematic HCPs are controlled at or below their defined acceptance limits, and detect new contaminant proteins that may have been previously unknown.

In this webinar we will discuss the benefits of LC-MS using SWATH® acquisition as a robust and sensitive method for low-level HCP analysis. We will demonstrate how SWATH® acquisition provides unbiased data collection across the entire mass range of interest, allowing for both MS and MS/MS data to be acquired on even the lowest abundant ions. This ensures data is collected on all the detectable species in your sample, and gives you the ability to quantify each component with high-quality data.

In this webinar you will learn:

-How SWATH® acquisition can detect and quantitatively monitoring multiple individual HCPs simultaneously

-How the unbiased SWATH® acquisition ensures that data is collected for all detectable HCPs in a sample

-How this method can be used to quantify HCPs below 10 ppm

 

Presented by Stephen Tate, Ph.D., Sr. Research Scientist, SCIEX

Stephen Tate received his PhD from University of Warwick, and has worked at multiple biotech and pharmaceutical companies in assay development. Following a move to Applied Biosystems to work as a support scientist he has spent the last 11 years working in research for SCIEX. Projects have included assisting with the design of the TripleTOF® system platform as well as being a pioneer of data-independent SWATH® Acquisition. Currently Dr. Tate is focusing on developing software to enhance the customer experience and simplify data processing, enabling biologists to access mass spectrometry.