Upcoming Webinars

How Digitization Can Improve Bioprocessing and Make Manufacturing More Robust

Presented by Charlotte Masy, Senior Manager in Manufacturing Science and Technology GSK Vaccines and Ciaran O’Keeffe, Director, Business Development & Channel Sales, Asia Pacific
25th September 2023

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

Presented by Alan Hood, Research Toxicologist at the US FDA/CDRH/OSEL/DBCMS and Koen Van der Plas, Study Director Medical Devices (E&L) at Nelson Labs.
28th September 2023

Evaluation of Optimal Extraction Conditions for Polypropylene, PBT Resins, and Chlorobutyl Rubber Elastomer – Using a Variety of Solvents and Extraction Conditions

Presented by Daniel Norwood, Principal Consultant at Feinberg Norwood & Associates Pharma Consulting and Lothar Habel PhD, Technical Advisor, Nelson Labs Europe
04th October 2023

Developing an Intensified AAV Production Process to Reduce CoGs

Presented by Dr. Wei Xue, Sr. Scientist at Ultragenyx Pharmaceuticals
09th October 2023

Challenges And Opportunities Of Continuous Bioprocessing And Risk Management

Presented by Sethu Madhavan, Global Head of Insulin Operations at Biocon Biologics, and Yvan Ruland, PhD. Head applications APAC - Sartorius Chromatography Equipment
13th October 2023

Advanced Technologies for Media and Process Optimization for Biologics Manufacturing

Presented by Dr. Yaron Silberberg, Chief Scientist & Head of Customer Solution Center at Ajinomoto Genexine and Dr. Mehran Rafigh Global Director Sales and Marketing at Yokogawa
17th October 2023

Navigating The Complexities of AAV Scale Up to Keep Pace with the Increasing Demand For these Viral Vector Delivery Systems

Presented by Seth Levy, Director of Bioprocess Development at Modalis Therapeutics and Gael Nicolas, Senior Technical Sales Specialist at Refeyn
19th October 2023

Development of a Blending Design Space Model to Control Uniformity in a Mini-Batch Direct Compression Line

Presented by Manel Bautista, Senior PAT Expert, Principal Scientist at Roche and Sebastian Sowinski, Key Account Manager at Sentronic and Bernhard Meir, Head of Continuous Manufacturing (OSD) at Gericke
23rd October 2023

Leveraging Digital Transformation To Deliver Operational Excellence

Presented by Dr. Parthasarathy Sampathkumar, Head, Group Center for Operational Excellence at Biocon Biologics and Sara Jane Bresee, Managing Director of APAC at MasterControl
31st October 2023

The Role of the Pre-use Post-sterilization Integrity Test (PUPSIT) in a Contamination Control Strategy

Presented by Mihir Kumar Patel, Senior Field Scientist at Cytiva and Sasha Nikolić, Manufacturing Process Development and Validation Expert at Reig Jofre
01st November 2023

Building an Effective Contamination Control Strategy for Sterile Filtration

Presented by Morven McAlister, Global Sr. Director, Regulatory and Validation Consultancy at Cytiva
02nd November 2023

RFC Implementation Strategy For Endotoxin Testing

Presented by Lindsey Silva, Ph.D. Director, Microbiology in Analytical Sciences at Genentech, Evelyn Der, Senior QC Scientist at Genentech, Kevin L. Williams, Endotoxin Sr Scientist at bioMérieux and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions Lonza Walkersville, USA
07th November 2023

Application of Low Field Bench Top NMR for Upstream and Downstream Stages of Biomanufacturing Process

Presented by Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi and Gabriella Gerzon, PhD Candidate, York University, Toronto, Canada
09th November 2023

Endotoxin Detection Challenges Associated With The Development Of A Novel VLP

Presented by Aleksandra Moleda, Senior Development Scientist at Allergy Therapeutics
14th November 2023

Design of a Global Sterility Assurance Program

Presented by Liz Brockson, Aseptic Processing and Sterility Assurance Lead in Global Sterility Assurance and Microbiology at Takeda and Vanessa Vasadi-Figueroa, Executive Director of Microbiology and Sterility Assurance at Quality Executive Partners
15th November 2023

British Pharmacopoeia’s ATMP Guidance

Presented by Clare Blue, Director of Biologics / Gene Therapy Development at Biogen, Ryan Smith, British Pharmacopoeia Specialist at Medicines and Healthcare products Regulatory Agency and Franz Schnetzinger, lead analytical development and QC at Gyroscope Therapeutics, A Novartis Company.
21st November 2023

Quality and Compliance Requirements For Cell and Gene Therapy Products

Presented by Sanjay Pandey, CAR-T, QA & Regulatory lead, Immuneel Therapeutics
24th November 2023

Insights into Practical Issues Associated with Extractables Testing of Medical Devices

Presented by Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions
05th December 2023

HCP Analysis in Biopharmaceuticals by Mass Spectrometry

Presented by Annu Uppal PHD. Director-Scientific Affairs & Strategy at USP and Anita Krishnan, Head of Analytical Sciences in Biocon Biologics
04th January 2024

Leveraging Development and Commercial Knowledge for Root Cause Analysis of Commercial Near-infrared Methods

Presented by Brendon Lyons, Senior Scientist, Forensics and Innovative Technologies group in Global Quality at Bristol Myers Squibb
11th January 2024

Toxicological Risk Assessment on Extractables and Leachables

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals
16th January 2024

The Use of AI and ML in Pharmaceutical Manufacturing – The Evolving Regulatory Environment in the GMP and CMC Reg Space in the US and Europe, Illustrated With Some Application Case Studies.

Presented by Dr. Gert Thurau, Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Roche
17th January 2024

A Digital Transformation Journey in Process Development – Building Automated Data Flows, from Equipment to eLN to Advanced Analytics

Presented by Christian Airiau, PhD, Global Head Data Sciences, Biologics Development at Sanofi
18th January 2024

Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions Lonza Walkersville, USA and Timothy Francis, Senior Technical Specialist for the LAL Division of FUJIFILM Wako Chemicals U.S.A. Corporation
06th 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
08th February 2024