Panel Discussion: Hot Topics in Large Molecule Bioanalysis
We asked our readers for their views on where large molecule bioanalysis is heading. Are ‘blended’ labs the future? How will regulation evolve? Hundreds of you completed our survey, and the results are now online.
In this exclusive Panel Discussion, we invited experts in a range of techniques and applications to share their thoughts on the issues raised in the survey. What were they surprised about? What does it mean for bioanalysts of the future? We also opened the discussion out to questions from our audience on any aspect of large molecule bioanalysis. Question submitted earlier by our readers covered method transfer, the future of LC-MS, guidance for ELISA, hybrid technology and dynamic range.
So whether you want to hear our audience’s burning questions, and the panel’s responses, or just want to listen to some of the leading experts in the field discussing this important area, we hope you will enjoy this lively discussion!
Yves Le Blanc
Senior Research Scientist
Yves Le Blanc is a Senior Research Scientist as part of the Applied Research Group at AB-SCIEX. His main areas of interest are application of hybrid MS-based technologies for qualitative and quantitative analysis of metabolites and peptides. Dr Le Blanc strong interest in quantitative come from his 2 years of experience as the manager of the LC-MSMS laboratory at Phoenix International (CRO, now part of Celerion). As part of AB-SCIEX, Dr Le Blanc occupied several roles from application chemist to lab manager as well as technical marketing lead. He has been directly involved in the development and marketing of the API 3000, API 4000, QTRAP based systems as well as TripleTOF 5600 and SelexION through his various role since he joined AB-Sciex in 1995. In recent years, his main area of research have focused on means of gaining selectivity in peptides analysis by extending capabilities of current systems.
Manager Field Application Scientist EU and Asia
Karolina Österlund joined Gyros in 2003, working on MALDI-MS applications and then immunoassays using Bioaffy CDs. She has been providing technical support for the Gyrolab immunoassay platform in clinical and bioprocess development for eight years and was instrumental in establishing the technology in North America and Europe. Her experience covers applications for pharmacokinetics, immunogenicity testing, biomarker monitoring, impurity testing and product quantification for therapeutic protein development, in both regulated and non-regulated environments. Karolina currently manages the Gyros European field application scientists as well as provides technical support to the efforts of Gyros Asia Pacific distributors. Karolina is involved in working groups such as the Global Bioanalysis Consortium, and the 21st Century Bioanalytical Initiative. She earned her M.Sc. in Chemical Engineering from Uppsala University, Sweden.
Principal Applications Chemist
Hillel Brandes completed his doctorate in biochemistry from the University of Missouri-Columbia in 1990. He then held positions as a postdoctoral associate and research assistant professor in the Protein Chemistry & Engineering Program at Oak Ridge National Lab in conjunction with the University of Tennessee. In 1997 Hillel joined the bioseparations group at Supelco and participated in the development of the Discovery®, Discovery BIO and Ascentis® HPLC column lines. Currently Dr. Brandes is a Principal Applications Chemist in Supelco’s Analytical Research Services group, where he focuses on applying the benefits of Fused-Core® and traditional high-performance columns for biopolymer separations with special emphasis on biotherapeutics.
Masood Khan joined KCAS in 2010 as Senior Director, bringing more than 30 years of experience in Immuno-analytical sciences & technologies, and senior management. Dr. Khan received his PhD in biochemistry from Aligarh University in India and has conducted post-doctoral studies at the National Institute of Environmental Health Sciences in North Carolina and McGill University, Royal Victoria Hospital in Canada. In 1989 he became one of the founding members of Phoenix International Life Sciences (MDS Pharma Services) where he developed and very successfully directed the company’s Ligand-binding Assay (LBA) Bioanalytical department for 9 years. Later he served in executive capacities for several major contract research organizations and pharmaceutical companies including Covance, NeuroBiotech, Medlmmune and GLP Solutions Inc. Over the past 20 years Dr Khan has been extensively involved with the strategic planning and development of GLP-compliant Ligand binding assay businesses. He has organized numerous educational events at the annual meetings of the American Association of Pharmaceutical Sciences (AAPS). He also helped in establishing the LBAB-Focus Group at the AAPS and has co-authored several authoritative reviews on the validation of LBA and biomarker assays. He has over 100 publications and presentations to his credit.
Senior Research Investigator II
Johanna Mora is currently a Senior Research Investigator responsible for regulated bioanalysis of biotherapeutics in support of GLP and clinical studies in the Department of Immunochemistry and Biomarker Development at Bristol-Myers Squibb (BMS) . She received a Bachelor of Science degree in Chemistry from the University of Costa Rica in 1999 and a Ph.D. in Bioanalytical Chemistry from the University of Kansas in 2004. Her graduate work combined analytical and molecular biology techniques applied to the detection of histone acetylation and single copy chromosomal regions. After graduating from the University of Kansas she worked at Genisphere (Hatfield, PA) in the adaptation of their 3DNA dendrimer technology to protein and miRNA detection using ELISA, protein microarrays and Luminex platforms, until she joined BMS in 2007. At BMS she leads a team of scientists in the bioanalysis of macromolecular therapeutics for PK, immunogenicity and discovery support. She is also responsible for development and execution of novel technologies and scientific strategie for bioanalysis of protein therapeutics. She serves as a mentor to her team and has served in several cross functional teams within BMS. She is an active member of AAPS and serves in the Emerging Technologies Action Program Commmittee within AAPS’ LBABFC and has served the APA Regulated Committee since 2011.
Lee Abberley is currently a Section Manager in the bioanalysis DMPK group at GSK, King of Prussia with responsibility for managing small and large molecule non and regulated bioanalytical support. PhD in Pharmaceutical Sciences from the University of Nottingham, UK. Worked at GlaxoSmithKline for 10 years, originally in the UK working in a DMPK group within the Neurosciences therapeutic area. Undertaken a lot of work on the Gyrolab platform to develop methods to support biopharmaceutical assets.