On Demand Webinars
Building the House of Rapid Sterility – A Successful Platform Approach to introducing Rapid Methods
Presented by Sophie Drinkwater, Senior Scientist in Microbiology at AstraZeneca, Jon Kallay, Senior Scientific Portfolio Specialist, Charles River Microbial Solutions
18th April 2024
Validation of Test Result Equivalence for Alternative BET assays, Including Recombinant Methods
Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, John Duguid, Executive Director, Research & Development at Vericel Corporation, Steven Walfish, Principal Consultant at Statistical Outsourcing Services, Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza and Alan Hoffmeister, Senior Global Technology and Market Development Manager at Charles River
27th March 2024
The Importance of Viral Clearance and Characterization in Gene Therapy Products
Presented by Ya-Chen Chang, Principal Scientist, downstream process development team at Regenxbio, Akunna Iheanacho, Ph.D. Chief Scientific Officer at Texcell – North America, Inc, Katelyn Pritchard, Viral Clearance Study Director at Texcell - North America, Inc and Maja Leskovec, Head of Process Development Viruses at Sartorius BIA Separations
19th March 2024
Leachable Risk Assessment Approaches: A Comparison of USP <665>, Biophorum, and Other Methods For Assessing Leachable Risk In Biopharmaceutical Manufacturing Systems
Presented by Presented by Jason Creasey, Managing Director at Maven E&L Ltd Managing Director at Maven E&L Ltd and Koen Smets, PhD, Senior Expert Extractables and Leachables at Nelson Labs NV
18th March 2024
Current State of PAT Applications for a Reliable and Effective PCM Equipment Operation
Presented by Richard Steiner, Senior Manager Business Strategy at Pharmatech Associates, A USP Company and Uwe Kirschner, Managing Director at Sentronic GmBH
11th March 2024
Navigating the Digital Transformation for Biopharmaceutical Process Development: Harnessing the Power of Microbial Systems and Innovative Technologies
Presented by Cecile Brocard, Director, Head of Downstream Development at Boehringer Ingelheim
07th March 2024
A Systematic Approach to Define Operating Space and MRT for Continuous Manufacturing ER Tablets: Opportunities and Challenges
Presented by Ahmed Zidan, Senior Staff Fellow (Pharmacologist) Center for Drug Evaluation and Research at FDA, Owen Rehrauer, President at Sentronic US Corp and Rodolfo J. Romañach, Ph.D. Center for Structured Organic Particulate Systems (C-SOPS) at the University of Puerto Rico
29th February 2024
A Systematic Approach to Deliver Data Science Solutions for Bioprocess Development Leveraging Digital Infrastructure and Data Management Solutions
Presented by Shyam Mudiraj, Lead Data Scientist and Senior Staff Engineer, Preclinical Manufacturing and Process Development (PMPD) group at Regeneron Pharmaceuticals
20th February 2024
Applications of Next Generation Sequencing for Viral Safety in Light of ICH Q5A R2
Presented by Jurgen Mullberg Associate Director at Bristol Myers Squibb and Colette Côté, Ph.D. Chief Scientific and Portfolio Officer & General Manager at PathoQuest Inc
08th February 2024
Solvent Selection for Controlled Extraction Studies of Pharmaceutical Packaging Components: An Experiment-Based Approach
Presented by Daniel Norwood, Principal Consultant at Feinberg Norwood & Associates Pharma Consulting
07th February 2024
