Key Sessions
Sanchayita Ghose, PhD
Keynote Address - Evolving Trends and Challenges in Development of Downstream Processes with Increasing Complexity of Biologics Portfolio
Bristol-Myers Squibb Company
Joseph Pekny
KEYNOTE: A Step-by-Step Guide for Achieving Data-Driven Smart Manufacturing and High Impact Manufacturing Social Media
Purdue University
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Main Conference - Day 1 - EST/EDT (Eastern Daylight, GMT-4)
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Well Characterized Biologics & Biological Assays - Room 208
7:55am - 8:00am
Chairperson’s Opening Remarks
- Da Ren - Founder and CEO, BioTherapeutics Solutions
8:00am - 8:30am
KEYNOTE ADDRESS – Specifying Spokes – Fit for Purpose Specifications
- Jeffrey Baker - Senior Fellow, NIIMBL; Strategic Advisor, CBI-MIT
8:30am - 9:00am
KEYNOTE ADDRESS – Emergence of Documentary Standards and Reference Materials for Biological Products
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
9:00am - 9:30am
KEYNOTE ADDRESS - Total Analytical Control Strategy for Base Editing Gene Therapy
- Johnson Varghese - Head of Analytical Research & Development, Beam Therapeutics
9:30am - 10:00am
Advanced Orthogonal Methods to Fully Characterize Process HCPs
- Eric Bishop - Vice President of Research & Development, Cygnus Technologies
Showing 1 of 1 Streams
Well Characterized Biologics & Biological Assays - Room 208
10:55am - 11:00am
Chairperson's Opening Remarks
- Sethu Alexander - Associate Director, Analytical Development-VRA, Takeda Pharmaceuticals
11:00am - 11:30am
Characterizing Color by online cIEF/MS and Peptide Mapping as a Result of Process Intensification of Biotherapeutics
- Kristen Nields - Senior Scientist, Janssen Biotech
11:30am - 12:00pm
Discovery of Oxidation Induced Crosslinks in a Recombinant Monoclonal Antibody
- Yi Yang, Ph.D. - Senior Scientist, Protein Chemistry Group, Genentech Inc
12:00pm - 12:30pm
Mass Spectrometry Enables More Definitive Process & Product Development Towards Well-Characterized Biotherapeutics: A Personal Account
- Jason Rouse, Ph.D. - Senior Director, Pfizer, Inc.
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Well Characterized Biologics & Biological Assays - Room 208
1:55pm - 2:00pm
Chairperson’s Opening Remarks
- Sethu Alexander - Associate Director, Analytical Development-VRA, Takeda Pharmaceuticals
2:00pm - 2:30pm
Accelerating Method Preparation to Speed Up Development Timelines
- Aaron Morgan - Director of QC Analytical, Wheeler Bio
2:30pm - 3:00pm
Structure Function Relationship Evaluation of Biosimilar Candidate: Case Study of Sialic Acid Challenge
- Xiaoxiao Liu - Process Development Scientist, Amgen
3:00pm - 3:30pm
Reducing Risk in the Biomanufacturing cold chain: The Durable Primary Packaging Solution
- Joe Cintavey - Product Manager, Gore & Associates
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