Characterizing Your Biotherapy: Improve Potency and Avoid Manufacturing Pitfalls
Interactive Workshop to Learn Why, What and When of Product Characterization
from Service Experts in this Essential Process
Registration for our March 21 event is closed.
Please register for our Cambridge event on March 22.
If you’re involved in the development of mAb or viral therapeutics, don’t miss this interactive workshop on Product Characterization and services available to you for characterizing your biotherapies.
We offer a complete range of analytical and immunological services, backed by a broad portfolio of assay platforms and expertise. You’ll gain both scientific and practical guidance that can greatly improve your chances of clinical and commercial success.
- Learn about the characterization process, from clone selection and cell line and vector development to lot release testing.
- Learn new technologies (HDX, Biacore, ArrayBridge) and new applications to help in the development of your biotherapy.
- Meet product characterization experts who develop assays and troubleshoot issues in commercial labs.
- Find out how outsourcing can de-risk biotherapy characterization, while increasing your chances of clinical and commercial success.
- Tour the M Lab™ Collaboration Center. Visit the Curiosity Hub and Pilot, Process Development, and Upstream labs.
- Network with local peers in mAb and viral therapy development.
Agenda
| 08:30 to 09:00 am | Check in and networking |
| 09:00 to 09:20 am | Introduction and Corporate Overview |
| 09:20 to 10:00 am | Planning for Success: Analytics for Robust Clone Selection |
| 10:00 to 11:00 am | Analytical Trends and Requirements - Phase 1 to Phase III |
| 11:00 to 11:30 am | Networking Break, M Lab™ Collaboration Center Tour |
| 11:30 to 12:30 pm | Relating Higher Order Structure to Kinetics Using HDX |
| 12:30 to 01:30 pm | Lunch, M Lab™ Collaboration Center Tour |
| 01:30 to 02:30 pm | Characterization & Rapid Release for Viral and Gene Therapies |
| 02:30 to 03:15 pm | Alternative Technologies for Measuring Host Cell Proteins |
| 03:15 to 04:00 pm | Novel Technology for Assessing Product Confirmation |
Our Industry Thought Leaders
Daniel Galbraith, Ph.D.
Director of Global Product CharacterizationMerck
Dr. Daniel Galbraith is responsible for the BioReliance® portfolio product characterization services strategy. Previously, he founded a company focused on analytical analysis of large-protein drugs, specifically developing novel models to better understand the mode of action for new drugs, and working on biosimilars. He also spent a decade focusing on vaccines, regulators, and biologics, and CROs. Dr. Galbraith holds a B.Sc. in Microbiology from the University of Glasgow, an M.Sc. in Forensic Science from the University of Strathclyde, and a Ph.D. in immunological and molecular biology studies from the University of Abertay, Scotland..
Marian L. McKee, Ph.D.
Senior Director, Head of Testing R&D ServicesMerck
Dr. Marian McKee is responsible for a scientific team that provides scientific, technical, and regulatory expertise to support biologic drug safety testing and manufacturing services. Prior to joining Merck, she was the Director of Collections with ATCC in Manassas, VA, and managed the microbiology and toxin component of the NIAID Biodefense Repository contract. With over 30 years of university, government, and industry laboratory experience, Dr. McKee is an assay development subject matter expert. She received her postdoctoral training at the National Cancer Institute at NIH, earned her Ph.D. in Microbiology and Immunology from the Uniformed Services University of Health Sciences, Bethesda, MD, and holds a B.S. in Zoology from Duke University.
Venue Information
Merck
400 Summit Drive,
Burlington, Massachusetts 01803
Phone: 800-645-5476