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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Analytical & Quality - Room 209
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
Online Amino Acid Analysis for Spend Media Control - Long-time Reaction Control Using the Agilent InfinityLab Online LC Solution
- Lorena Lopez - LC Applications Scientist, Agilent
Showing 1 of 1 Streams
Analytical & Quality - Room 209
11:00am - 11:30am
Integration of PAT and HTPD for streamlining high concentration UF/DF process development to enable subcutaneous product administration
- Jessica Hung - Principal Scientist, Bristol Myers Squibb
11:30am - 12:00pm
Recent progress towards real time LC‐ automated analysis and assessment of system suitability
- Nicole Ferreira - Associate Principal Scientist, Chemistry, Merck
- Jan Verelst - Global Business Development Manager SIPAT, Siemens
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.
Showing 1 of 1 Streams
Analytical & Quality - Room 209
1:55pm - 2:00pm
Chairperson’s Opening Remarks
- Da Ren - Founder and CEO, BioTherapeutics Solutions
2:00pm - 2:30pm
Opportunity and Challenges in Implementing PAT Tools as Rapid Analytics during Process Development of Biologics
- Dhanuka Wasalathanthri, PhD - Senior Principal Scientist, Bristol Myers Squibb
2:30pm - 3:00pm
PAT Strategy for In-Line Protein Concentration Monitoring During UFDF
- Lunedt Gonzalez-Pepe - Scientist I, Alexion Pharmaceuticals, AstraZeneca Rare Disease Unit
3:00pm - 3:30pm
Real time end-to-end monitoring of analytical method performance from development labs to QC
- Neeraj Agrawal - Director, Amgen
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