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
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.
Cambridge Healthtech Institute
Phone: +44 7791 866489
For partnering & sponsorship information, please contact:
Manager, Sponsorship & Exhibits
Cambridge Healthtech Institute