Part One: Analytical Methodology and PTMs

This conference focuses on advances with analytical technology and their practical application. Pioneers will present their experiences with a range of technologies, particularly mass spec, epitope, peptide and computational mapping, microarray platforms, and fluorescent labeling. Presentations will include preparation of stable samples, measures to increase the speed of analytics and increase automation, advances with precision, the software used, and means of interpreting results. This leads onto applications of advanced technologies for a range of products, focusing on identification of forms of amidation and abnormal post translational modifications, protein and sequence variants, and glycosylation and glycan analysis. Practical examples will be presented, for example for clone and cell line selection, developability risk assessment, candidate selection, product optimization, affinity binding, the structure-function relationship, determining acceptance criteria and finally for product quality and manufacturing consistency and CQA assessment.


Novel Methods to Speed Up PTM Profiling to Support Early Developability Risk Assessment of Biologics Candidates

Christian Graf, Ph.D., Principal Scientist, BPRD Integrated Biologics Profiling, Novartis Pharma

Characterization of Higher Order Structure for a Biotherapeutic

Christel Veyssier, Ph.D., Scientist, MedImmune

Analytical Characterization for Biologics Candidate Selection and Optimization: Where Are We Now and Where Do We Go from Here?

Guodong Chen, Ph.D. Senior Principal Scientist, Bioanalytical and Discovery Analytical Sciences, Research and Development, Bristol-Myers Squibb Company

Title to be Announced

Shantha Raju, Ph.D., Scientific Director, Biologics Research, Centocor, Inc.


Tools to Examine the Driving Forces behind Chemical Degradation Hot Spots to Help with Candidate Selection

Hubert Kettenberger, Ph.D., Principal Scientist, Innovation Center, Penzberg, Large Molecule Research, Roche

Discovery and Characterization of a Novel Free Drug Species in Antibody Drug Conjugates

Richard Beardsley, Ph.D., Scientist, Protein Analytical Chemistry, Genentech, Inc.

Case Study on Detection of Abnormal PTMs, Low Level Mutations, Sequence Variants, and Amino Acid Substitutions

Dingyi Wen, Ph.D., Principal Scientist, Analytical Biochemistry, Biogen Idec, Inc.

Antibody Fc Deamidation: The Well-Known and Less Well-Known

Taylor Zhang, Ph.D., Senior Scientist and Group Leader, Protein Analytical Chemistry, Genentech, Inc.



High Throughput Methodology in Characterization of Glycoproteins

Huijuan Li, Ph.D., Director, Sterile Product and Analytical Development, Bioprocess Development, Merck & Co., Inc.

Application of Lectin-Based Microarray in Direct Glycan Profiling of Therapeutic Proteins

Lei Zhang, Ph.D., ORISE Fellow, Office of Biotechnology Products, CDER/FDA

Case Study on Experiences with Glycosylation Analysis for Non-mAb Biotherapeutics

Sherry Castle, Ph.D., Senior Analytical Development Specialist, Shire

Glycoprofiling and Structure-Activity-Relationship of a Highly Complex Glycoprotein

David Spencer, Ph.D., Scientist II, Analytical Biochemistry, MedImmune, LLC

Protein and Sequence Variants

Analysis of Protein Variants from Serum to Support CQA Assessment During Early Development

Fabian Higel, Ph.D., Scientist, PK Profiling, Analytical Characterization, Sandoz Biopharmaceuticals

Case Studies on Sequence Variance Analysis of Mabs with State-of-the-Art Mass Spec

Heather DeGruttola, Ph.D., Scientist, Mass Spectrometry and Biophysical Characterization, Pfizer, Inc.


For questions about the meeting, please contact:
Nicole Lyscom, Ph.D.
Conference Director
Cambridge Healthtech Institute
Phone: +44 7791 866489

For partnering & sponsorship information, please contact:
Jon Stroup
Manager, Sponsorship & Exhibits
Cambridge Healthtech Institute
Phone: 781-972-5483

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