Accelerating Analysis in the BioPharma Laboratory

Part 1: Overview of Agilent Biopharma

Presenter: Mike Knierman (Biopharma Workflow Manager, Agilent Technologies, Inc.)

Part 2: Analytical Innovations to Speed-up Antibody Characterization

The characterization biotherapeutics is essential to assess their safety, quality, and efficacy. In this presentation, we show novel technologies that can address the growing demand for comprehensive and faster characterization of multi-specific antibodies. In the first example, Mobile Affinity Selection Chromatography is used to rapidly assess antibody titer and aggregation levels of crude culture filtrate. We take advantage of this method for unbiased analysis of mispaired chains and aggregates directly from culture supernatants obviating a protein A clean-up step. We show fast aggregate and titer molecular structure quantifications without sample preparation can be achieved with multi-sampler overlapped injections, dramatically improving analysis throughput (~ 2.5 min per sample) without carryover. In the second example, mAb digestion process (> 30 min) is accelerated on the surface of microdroplets (<1 ms) (Anal. Chem., 2021, 93, 3997-4005). We show automated microdroplet reactions under native-pH conditions by combining programmed flow injection with a JetStream ionization source. Intact subunit mass analysis and middle-down characterization of antibody subunits are completed every 2 min. (Anal. Chem., 2023, 95, 3340-3348). Finally, we propose droplet reactions every 2-4 seconds per antibody sample using RapidFire BLAZE mode for ultrafast sample introduction and digestion. We envision, that these analytical innovations will enable comprehensive and faster analysis of biotherapeutics.

Presenter: Harsha Gunawardena, Ph.D. (Senior Scientist, Mass Spectrometry, Janssen Research & Development, The Janssen Pharmaceutical Companies of Johnson & Johnson)

Harsha Gunawardena obtained his Ph.D. in Analytical Chemistry from Purdue University and a Master of Science degree in Analytical Chemistry from University of North Carolina. He was a post-doctoral fellow at the Lineberger comprehensive cancer center, UNC school of medicine where his research focused on refining quantitative platforms for large-scale clinical proteomics and proteogenomic analysis. He was a co-investigator for the NCI clinical proteomics tumor analysis consortium (CPTAC), the ENCODE consortium. His industry career as scientist started at Bayer Health Care providing mass spectrometry and bioanalytical support of plasma-based therapeutics. He later worked at Amgen applying proteomics methods to support biomarker programs and discovery programs in oncology and inflammation. In his current role at Janssen R&D, Johnson & Johnson, he supports discovery early development programs that span several therapeutic modalities.

Part 3: Towards the Absolute Quantitation of the Human Proteome: Next Generation of Absolute Protein Quantitation in Biological Matrixes; Higher Multiplexicity While Faster, Robust and Sensitive

Presenter: Christoph Borchers, Ph.D. (Professor, Department Oncology, McGill University; CSO, MRM Proteomics)

Professor in the Department of Oncology at McGill University, and holds the Segal Chair in Molecular Oncology. His research involves proteomics and metabolomics technologies for clinical diagnostics and structural proteomics. He is also head of a newly established Omics laboratory for personalized medicine and health at Skoltech, Moscow, Russia.