Advancements in Host Cell Protein Analysis
Host cell proteins (HCPs) are proteins that are produced by the host cells used in the production of biopharmaceuticals. These proteins can be impurities in the final product and due to their potential to adversely impact product safety and efficacy, HCP levels must be monitored and controlled in drug products and are strictly regulated.
By employing advanced analytical techniques, biopharmaceutical companies can effectively monitor and control HCP levels, ensuring the production of safe and effective therapeutic products. Join us in this unique webinar where experts from Industry, pharmacopeia and Agilent will share insights on latest advancements on HCP analysis.
Key learnings:
- Best practices for sample preparation, MS data acquisition, data analysis and reporting
- Orthogonality of MS and traditional methods
- USP approach for HCP reference materials to support identification and quantitation of HCPs
- New advancements in detection and sensitivity
- Process and analytical controls for host cell impurities
- LC/MS based HCP identification approaches
- Mandates on host specific HCP assays
- and more
Presenter: Dr. Annu Uppal (Director - Scientific Affairs & Strategy, U.S. Pharmacopeia - India)
Annu Uppal, in her role as Director, Scientific Affairs and Strategy, leads a team of scientists across five regions—North America, EMEA, South Asia, Greater China, and LATAM—to drive and support USPs scientific priorities. Annu leads pivotal initiatives such as USP's Science & Quality Framework and Knowledge Hubs for Multi-Attribute Methods, highlighting her dedication to advancing standards and scientific progress.
Annu's areas of expertise include glycosylation analysis, MAM, native mode, and host cell protein analysis. She holds a Ph.D. in Biotechnology from Aligarh Muslim University, India and has authored numerous peer-reviewed manuscripts and book chapters. Annu also serves as faculty for the USP biologics education program on method development and validation.
Presenter: Dr. Amarnath Chatterjee (Director and Head Analytical Sciences Biosimilars, Cipla Limited)
Dr. Amarnath is a Biophysicist with more than two decades of experience working with peptides and proteins. Post PhD at the prestigious Tata Institute of Fundamental research, Mumbai, he worked at the Scripps Research Institute California, USA in the laboratory of Nobel Laureate Prof. Kurt Wuthrich. He has substantial experience in the regulatory role of Biophysics in the Biopharma industry.
Dr. Amarnath leads the biologics development technical operations, providing expert advice on analytical workflows for quality control and characterization of client projects. He strategizes and supports the generation and analysis of physicochemical data under CMC, utilizing various spectrometric and spectroscopic methodologies for product release, regulatory submissions, and process development
Presenter: Dr. Ashish Pargaonkar (Biopharma Workflow Commercialization Lead, Agilent Technologies)
Dr. Ashish Pargaonkar is a Lead for Biopharma Workflow Commercialization team for India and also Manager for Centre of Excellences at Bangalore. A Microbiologist by education with a Ph.D, he holds more than 20 years of experience for Biopharma market applications on Hi Resolution Mass Spectrometry.
He has a long record of successful demonstrations and customer engagements on workflows for CQA’s, Intact mass, peptide mapping, HCP and Glycans using Agilent state-of-the art solutions. He has authored ASMS posters on media components and therapeutic peptides. Dr. Ashish has been invited speaker at several conferences and workshops at Biosimilar Congress, ADC 2018, IIT (Mumbai, Delhi), ICT (Mumbai), PSI events.
