Optimal Industrial Technologies

 

Upcoming Webinars

Analytical Assessment of Leachables in Biological Drug Products: FDA Approach and Experience in Reviewing Information

Presented by Andrey Sarafanov; PhD., Principal Investigator at U.S. FDA, Center for Biologics Evaluation and Research, Sona Kovackova, PhD, Scientific Expert – E&L at Nelson Labs, and Tine Hardeman, Manager Material Development bij at Datwyler
04th September 2024


Fully Continuous Purification Platform Using Nanoparticles With Ligands and Ultrafiltration

Presented by Irina Ramos, Director, Bioprocess Technology and Engineering at AstraZeneca
06th September 2024


A Future of MQL and Managing Risk Release

Presented by John R. Logar, Senior Director, Sterility Assurance at Johnson & Johnson
12th September 2024


Established Conditions in Analytical Procedure: Overview, Regulatory Examples and an FDA Laboratory Study

Presented by Jinhui Zhang, Chemist at FDA/CDER and Dimple Shah, Pr. Scientist at Waters Corporation
17th September 2024


Medical Device Chemical Toxicological Risk Assessments: Applying Toxicological Principles to Meet the Challenge

Presented by Alan Hood, Toxicologist at the US FDA/CDRH/OPEQ and Sandi Schaible, Senior Director of Analytical Chemistry and Toxicology at WuXi AppTec
23rd September 2024


Adventitious Agent Testing For MMV: How Much Do We Really Know?

Presented by Maria Farcet, Head of Cell Culture, Virus Models & Serology in the Global Pathogen Safety / Global Quality team at Takeda and Amina Cherif Louazani, PhD, Viral Safety Manager at PathoQuest
01st October 2024


Downstream Platform Process Development for AAV viral vectors; Challenges and Opportunities

Presented by Presented by Parag Kumthekar, Lead Gene Therapy Downstream Process Development at UCB
02nd October 2024


Defining Patient-Centric Specification in a Risk-Based Control System

Presented by Gerald Gellermann, Scientific Officer at Novartis
22nd October 2024


The Factory of the Future

Presented by Robert Dream, Principal Consultant at HDR Company LLC
29th October 2024


Evaluating Analytical Strategies to Quantify Capsid Titre: Towards a Platform-Method Approach to Accelerate AAV Drug Product Development

Presented by Dr. Marilia Barros, PhD, Principal Scientist Biologics & Gene Therapy Drug Product Development at Regeneron and Laura Pala, Product Marketing Manager at Refeyn
30th October 2024