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2016 Biomanufacturing Technology Summit

Open Innovation Resources for Biomanufacturing

Therapeutic proteins represent a number of the currently top 10 best-selling drugs and have combined sales of almost $64 billion per year. The enormous market potential for biosimilars or biobetters has created a crowded field of developers. As a result, there is a growing emphasis on emerging analytical techniques and their lifecycle appropriate application. Industrial, federal, and academic researchers will gather to discuss available open innovation resources and technological advancements for fueling biopharmaceutical development. On Thursday, June 23, 2016 at 8:30 AM join the thought leaders, policy makers, and developers of therapeutic proteins as we present current trends, ideas, and predictions on the use of open innovation biomanufacturing resources and emerging technologies.

MORNING SESSION:  Open Innovation and State-of-the-Art Characterization Methodology, Chair: John Marino, NIST

AFTERNOON SESSION:  Emerging Technologies for Higher Order Structure, Chair: William Bentley, UMD


Dr. Thomas Fuerst, Director, Institute for Bioscience Biotechnology Research

Dr. John Marino, Leader, Biomolecular Structure & Function Group, National Institute of Standards and Technology


Institute for Bioscience and Biotechnology Research
9600 Gudelsky Dr.
Rockville, MD 20850 
(240) 314-6000

Morning Session: Open Innovation and State-of-the-Art Characterization Methodology

Chair: John Marino, NIST

8:30 Registration Opens

9:00   Welcome and introduction to IBBR, Thomas Fuerst, IBBR

9:15 Introduction to NIST, John Marino, NIST

9:30   Antibody Reference Standard Characterization, Richard Remmele, Medimmune

10:00  Getting to the future state in Biomanufacturing: Role of collaboration, Linda Narhi, Amgen

10:30  Coffee Break and Posters

11:00  Leveraging the MAM to Improve Biotherapeutic Characterization, Richard Rogers, Just Biotherapeutics

11:30  N-linked glycan product characterization without losing too many details, Justin Prien, Shire

12:00  Lunch and Poster Session


Afternoon Session: Emerging Technologies for Higher Order Structure

Chair: William Bentley, UMD

1:30   Characterization of pegylated protein therapeutics and antibodies by 2D NMR, Yves Aubin, Health Canada

2:00   Hydrogen exchange mass spectrometry: An enabling tool in therapeutic protein development, David Weis, University of Kansas

2:30   Coffee Break and Poster Session

3:00   Covalent labeling and mass spectrometry to map epitopes and establish biosimilarity for biologic drugs, Mark Chance, Case Western

3:30 Roundtable Introduction, Steven Kozlowski, FDA

4:00 Roundtable Discussion - Prospective next steps for biopharmaceutical open innovation and Reference Materials, Led by John Schiel, NIST               

Steven Kozlowski, FDA
Darryl Davis, JNJ
Oleg Borisov, Novavax

4:30   Closing Remarks and Awards, John Schiel, NIST

Created June 16, 2016, Updated June 18, 2016