Mass spectrometry has become an increasingly common approach for identification and quantitation of Host cell proteins (HCPs) to support risk assessment and process development, as well as characterization and quality control. This presentation will provide an overview of the proposed general chapter <1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry. The best practices for instrument selection, sample preparation, LC separation, MS data acquisition, MS data analysis and reporting, with particular attention to the orthogonality of MS and traditional methods will be discussed. Additionally, there will be an update on the development of physical reference materials to support identification and quantitation of HCPs of particular concern. 

Best Practices for HCP Analysis in Biopharmaceuticals by Mass Spectrometry

Presented by Annu Uppal PHD. Director-Scientific Affairs & Strategy at USP

Annu Uppal is currently working as Director Scientific Affairs at United States Pharmacopeia (USP), leading a global team of scientists responsible to drive and support organizational scientific priorities that advance the science of quality for medicines using USP’s science and standards. She is also leading the USP’s initiative of Knowledge hub for Multi Attribute Methods (MAM), scientific engagement activities and external collaborations. Before joining USP, she worked as a technical global lead for characterization and quantification of large biologics at SCIEX. She has experience in physiochemical characterization and impurity profiling of mAbs, peptides & other protein biotherapeutics. Her area of interest are glycosylation analysis, MAM, native mode and host cell protein analysis. She received her Ph.D. in Biotechnology from Aligarh Muslim University. Annu is the author of 30+ peer reviewed manuscripts and book chapters. She is also faculty for USP biologics education program on method development and validation for biotherapeutics.

Mass spectrometry based qualitative and quantitative profiling of HCP

Presented by Anita Krishnan, Head of Analytical Sciences in Biocon Biologics

Anita has about 15 years of experience in biosimilar development assuming several leadership roles spanning a wide portfolio of biosimilar products in advanced and emerging markets. She has made significant strategic and tactical contributions across the spectrum of product development, regulatory interactions, in-licensing assets, technical audits, alliances, and partnerships in her career. In her current role as Head of Analytical Sciences in Biocon Biologics she is responsible to promote scientific excellence, strategically drive innovation and mentor leadership in R&D. Prior to Biocon, she has worked for Lupin, Intas and Kashiv and is a Key Opinion Leader for mass spectrometry based analytical tools. She holds a PhD degree in Biotechnology from the research conducted at IICT and CCMB, Hyderabad through CSIR merit scholarship.