Cambridge Healthtech Institute’s 6th Annual
Biotherapeutics Analytical Summit
Part Two: Characterization and Compliance
Focusing on ADCs, Impurities, Host Cell Proteins, Reference Standards, CQAs and Regulatory Concerns

March 10-11, 2015 | Hyatt Regency | Harbor Court | Baltimore, MD


Characterization and Compliance focuses on application of advanced analytical technologies throughout development. It presents characterization of the complex heterogeneity of ADCs by means of sophisticated technologies such as new inductively-coupled plasma mass-spec ICP-MS, capillary electrophoresis and protein mass spectrometry. A range of technologies for aggregate characterization will also be presented together with an FDA study on pathways that lead to aggregation.  Because host cell proteins have become very hot, we have included a presentation (and short course) on the most advanced technologies for their characterization. Practical case studies on control and monitoring of Critical Quality Attributes and on phase-specific characterization will be presented.Reference standards for product quality and manufacturing consistency will be presented by the FDA and backed up with examples from NIST and a case study from the industry. Regulatory issues are further addressed by regulatory and FDA on concerns such as reference standards, product comparability and the new topic of mycoplasma detection.

REFERENCE STANDARDS 

Regulative Perspectives on the Use of Reference Standards in the Development of Therapeutic Proteins

Baolin Zhang, Ph.D. Senior Investigator, Therapeutic Proteins, Office of Biotechnology Products, CDER / FDA

 

The NIST mAb: A Reference Material to Supplement Biopharmaceutical Characterization and Compliance

John E. Schiel, Ph.D., Research Chemist, Biomolecular Measurement Division, NIST

 

Strategy for Building an In-House Reference Standard System for Early Development through to Commercialization

Michael Huang, Ph.D., Senior Scientist, Analytical Biotechnology, Biopharmaceutical Development, MedImmune
 

NEW APPROACHES FOR CHARACTERIZATION OF SPECIFIC PRODUCTS

New Approaches to Characterization of Specific Products such as ADCs and Interferons

Igor Kaltashov, Ph.D., Associate Professor, Chemistry, University of Massachusetts

Overcoming Analytical Challenges in Characterization of Heterogeneities of Antibody Drug Conjugates

April Xu, Ph.D., Senior Principal Scientist & Group Leader, BioTx – Analytical R&D, Pfizer, Inc.


CHARACTERIZATION AND CONTROL OF SUB-VISIBLE PARTICLES AND AGGREGATES

Assessing Aggregation of Therapeutic Proteins in Human Plasma

Shen Luo, Ph.D, Senior Staff Fellow, Therapeutic Proteins, Office of Biotechnology Products, CDER/FDA

Development of Mass Spectrometry-Based Approaches to Study the Dimerization of Therapeutic Monoclonal Antibodies

Shunhai Wang, Ph.D., Scientist, Analytical Chemistry, Regeneron Pharmaceuticals, Inc.

Reversible Self-Association and Stability in a Monoclonal Antibody

Julie Wei, Ph.D., Scientist II, Protein Pharmaceutical Development, Biogen Idec, Inc.


DEVELOPENT OF ANALYTICAL TECHNOLOGY TO DETECT PRODUCT-RELATED IMPURITIES

Application of Different Approaches for Assessment of HCPs: Traditional Immunoassays, Mass Spec and a Proteomic Approach

Martin Vanderlaan, Ph.D., Director, Analytical Operations, Genentech


CHARACTERIZATION STRATEGY TO SUPPORT CRITICAL QUALITY ATTRIBUTES

Case Study on Control and Monitoring of Critical Quality Attributes during Process and Product Development

Tamer Eris, Ph.D., Principal Scientist, Analytical and Formulation Science, Amgen, Inc.


REGULATORY PERSPECTIVES

Regulatory Guidance on Phase Specific Characterization

Emily Shacter, Ph.D., Consultant, ThinkFDA

Integration of Product Comparability into Process Development Strategies to Ensure Regulatory Approval

Alain Bernard, VP, Technical Operations GPS, UCB Pharma

A Regulatory Perspective on the Detection of Mycoplasma in Biotechnology Products

Laurie Graham, Ph.D., Product Quality Reviewer, Monoclonal Antibodies FDA/CDER


PHASE SPECIFIC CHARACTERIZATION

Case Studies on Phase-Specific Characterization of Therapeutic Proteins

Ping Feng, Ph.D., Director, Analytical Sciences, Biological CMC, Teva Pharmaceuticals, Inc.


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

For partnering & sponsorship information, please contact:
Jon Stroup
Manager, Sponsorship & Exhibits
Cambridge Healthtech Institute
Phone: 781-972-5483
Email: jstroup@healthtech.com 


Register Now 


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