Upcoming Webinars

Raw Material Lot Variability Challenges During Manufacturing of Biosimilars mab

Presented by Sekhar Reddy, DSP Lead for Biosimilars at Biocon MSAT
25th January 2019


Using In-Vitro Dissolution to Support Post Approval Changes Global Regulatory Expectations

Presented by Xin Bu, Principal Scientist at Bristol-Myers Squibb
05th February 2019


Quality-By-Design in Spray Drying Processes – Transfer Lab to Production

Presented by Sune Klint Andersen at Janssen Pharmaceutical Companies of Johnson & Johnson and João Vicente Senior Scientist - Particle Engineering Team Leader at Hovione
19th February 2019


Host Cell Protein Characterisation and Mass Spectrometry Strategies

Presented by Xuezhi Bi, Group Leader (Proteomics) /Senior Scientist at Bioprocessing Technology Institute, A*STAR
19th February 2019


PDA Technical Report on Low Endotoxin Recovery: Implications to the Industry

Presented by Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Roche
21st February 2019


Effect of Cell Culture Process Change from Fed-batch to Continuous on Productivity and Product Quality

Presented by Ru Zang, Associate Director at Mersana Therapeutics and John Bonham Carter, Director of Upstream Sales at Repligen
25th February 2019


Continuous Manufacturing: Business Case Drivers and Deployment Strategies

Presented by Lawrence De Belder, Senior Principal Engineer Continuous Manufacturing at Johnson and Johnson and Richard Steiner, Business Development Manager at GEA Group
26th February 2019


Real Time Online Chromatography Monitoring of Product Quality Attributes for Biologics Continuous Manufacturing Process

Presented by Gang Xue, Scientific Director at Amgen Inc.
28th February 2019


Challenges in the Development of Continuous Processes for Vaccines

Presented by Danny Vellom of Sanofi Pasteur Biologics, Inc.
04th March 2019


Lifecycle management of single use technologies

Presented by Francis Verhoeye, Director Single Use Technologies, GSK Vaccines
05th March 2019


Risk Based Approaches to Use of Closed Systems in Renovations of Existing Biopharma API Facilities

Presented by Lars Hovmand-Lyster, Senior Engineering specialist in Novo Nordisk Global Project Office (GPO) Engineering management department and Ernest Jenness, Senior Product Manager for Mobius Single-Use Products at MilliporeSigma
05th March 2019


From Early Stage to Late Stage Development: How to Characterize a Perfusion-based Vaccine Production Process Using QbD?

Presented by Perrine Rouel, Scientist - Up Stream Processing, The Janssen Pharmaceutical Companies of Johnson & Johnson and Tom Jeffery, Application Specialist – Ambr Technology KAM Europe at Sartorius Stedim Biotech
07th March 2019


Achieving Seamless Scale-Up and Technology Transfer – A Case Study in Single-Use Bioreactors

Presented by Ying Wang, Ph.D., Senior Scientist I, Manufacturing Sciences, AbbVie Bioresearch Center
11th March 2019


Managing Biologics Process Analytical Technology in Pfizer

Presented by Keith Davis, Principle Scientist at Pfizer
12th March 2019


Integrity Assurance for Single-Use Systems: End-User Perspective

Presented by Charlotte Masy, Project Manager in global support GSK vaccinés and Donald Young, Sr. Product Manager at Thermo Fisher Scientific
14th March 2019


Understanding the Propensity of Sequence Variants During Cell Line and Culture Process Development

Presented by Dr. Lisa Marzilli, Associate Research Fellow and group leader at Pfizer, USA
18th March 2019


Transformational Science: Moving from Challenges of High Concentration Protein Formulations Development to Meet the Needs of High Potent Bispecifics

Presented by Sachin Dubey, Ph.D., Head of Formulation and Analytical Development at Glenmark Pharmaceuticals SA
19th March 2019


mAb Industry in China : Biosimilars vs Innovative Biologics

Presented by Dr. Joe X Zhou, CEO at Genor Biopharma, Walvax Bio Group and Floris De Smet Bioprocess Technical Support & Field Marketing at Sartorius Stedim Biotech
21st March 2019


Extractables and Leachables have been used interchangeablely for too long. Are we still confused?

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Diego Zurbriggen, Technical Account Manager at West Pharma
25th March 2019


Introducing Chromassette®, a modular chromatography platform enabling next-generation bioprocess purification.

Presented by Ping Huang, Director, Head of DS BioProcesses, OED, Abbvie at Redwood and Masayoshi Nagaya, Sr. Global Technology Manager at JSR Micro Inc
04th April 2019


Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century

Presented by Presented by Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi
08th April 2019


Case-by-Case Assessment of Bioburden (CCAB): A Comprehensive Approach to Assess the Impact of Microbial Impurities on Patient Safety and Product Quality of Biologics

Presented by Dr Friedrich von Wintzingerode, Senior Manager, Global Analytical Science & Technology (gASAT) Microbiology, Global QC bei Roche
09th April 2019


Application of Multivariate Data Analysis for Process Diagnostic and Root Cause Analysis

Presented by Hossein Sahraei, Data Scientist, Sanofi Pasteur
10th April 2019


Applying Low Frequency Raman to QbD in Pharmaceutical Development

Presented by John Wasylyk, Senior Principal Scientist at Bristol-Myers Squibb Company and James Carriere, Product Line Manager for Coherent’s THz-Raman product line
26th April 2019


Analysing Complex Data in the Pharmaceutical Industry: The Case for Multivariate Analysis

Presented by Presented by Mike Tobyn, Research Fellow at Bristol-Myers Squibb
02nd May 2019


Employing Hot Melt Extrusion As a Cost Effective Method of Increasing Solubility Of Water Insoluble API’s

Presented by Dennis Douroumis, Professor in Pharmaceutical Technology and Process Engineering at University of Greenwich and Dirk Leister, Leader Technical Marketing at Thermo Fisher Scientific
07th May 2019


Do Extractable Protocols Truly Help – An End User Perspective

Presented by Ekta Mahajan, Genentech/Roche
08th May 2019


Characterization of Subvisible Particles in Protein and Viral Vaccines

Presented by Marina Kirkitadze,Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur
21st May 2019


Mapping Future Technology Needs For Real Time Release Testing

Presented by Dr Udayanath Aich, Principal Scientist at Sanofi
22nd May 2019


Regulatory Strategies and Case Studies for Rapid Sterility Testing of Gene and Cell Therapy Products

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC
23rd May 2019


Viral Safety by Design for Cell and Gene Therapy Products

Presented by Mark Plavsic, Chief Technology Officer at Lysogene and Archie Lovatt, Life Sciences Biosafety Scientific Director at SGS
24th May 2019


New Drug Product Development Using Continuous Manufacturing

Presented by Giustino Di Pretoro, Associate Director Drug Product Development an Johnson and Johnson And Dr. Robin Meier, Manager Scientific Operations at L.B. Bohle Maschinen
28th May 2019


Implementation Of An Affordable And Scalable Manufacturing Strategy For Gene Therapy Products

Presented by Bastiaan Leewis, MSAT manager of Industrialization at MeiraGTx
29th May 2019


Innovative solutions from Industry 4.0

Presented by Michael May, President and CEO, CCRM at Centre For Commercialization Of Regenerative Medicine
10th June 2019


Pharmaceutical Forensics for Safe Manufacturing and Supply

Presented by Ravi Kalyanaraman, Director at Bristol-Myers Squibb and Jeremy Peters, Scientist at Bristol-Myers Squibb
14th June 2019


Case Study and Experience on Sanofi’s Implementation of BPOG’s Leachable Risk Assessment Model

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of E&L at SGS
10th September 2019