Upcoming Webinars

Rapid Microbiology Applications in the COVID-19 Era

Presented by Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC, Ulrich Herber Director of Technology and Market Development Charles River and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
04th August 2020

Application of USP 665 data to support qualification of single use systems

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Desmond G. Hunt, Principal Liaison at United States Pharmacopeia and James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy at Pall Biotech
01st September 2020

The New Annex 1 Revision And The Impact on Using Rapid Methods For Environmental Monitoring

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC
02nd September 2020

Fully Utilizing Closed Systems in Modern BioPharma Facilities

Presented by Lars Hovmand-Lyster, Senior Engineering Specialist in Novo Nordisk Global Project Office (GPO) Engineering Management Department and Ross W. Acucena, Applications Director, Entegris LifeScience
03rd September 2020

Quantification and Control of Amorphous contents by Raman, Application and Case Studies in Pharmaceutical Processing

Presented by Michelle Raikes, M.S., Scientist IV and Dr. Fredrik Nordstrom, Sr Research Fellow at Boehringer Ingelheim
04th September 2020

Global Sterile Transportation and Formulation of an Adjuvant

Presented by Charlotte Masy, Project Manager in global support GSK vaccinés and Donald Young, Sr. Product Manager at Thermo Fisher Scientific
08th September 2020

Extractables and Leachables Testing Using a Quality Risk Management Approach

Presented by Dhaval Tapiawala, Principal Scientist at Pfizer
09th September 2020

From Concept to Market – Unique Approaches in Biomanufacturing

Presented by Jincai Li, Vice President of WuXi Biologics and Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific
11th September 2020

Analytical Strategies for Comparability in Bioprocess Development

Presented by Dr Christine P. Chan, Ph.D. Director in Global Manufacturing Science & Technology at Sanofi
15th September 2020

A Comprehensive Approach to Assess the Impact of Microbial Impurities on Patient Safety and Product Quality of Biologics

Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST Project (individualized Neoantigen Specific Therapy) at Roche and Shabnam Solati, CEO & Co-Founder at CTL-MAT
16th September 2020

Current Bacterial Endotoxins Test (BET) and its Intended Use

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates
24th September 2020

Strategies to Overcome Low Endotoxin Recovery Using the Conventional LAL Assay

Presented by Dr. Ruth Daniels, Senior Scientist - Microbiology Expert at Janssen and Kevin L. Williams, Microbiological Test Development at bioMérieux
28th September 2020

Digital Transformation Strategy Development in Biologics Manufacturing: One site’s journey

Presented by Robert Dimitri, Associate Director, Digital and Data Sciences Lead at Takeda and Pep Gubau, CTO and co-founder, Bigfinite
01st October 2020

MES – Integrating Technology, Quality and Compliance – Opportunities, Challenges and Strategies.

Presented by Sachin Bhandari, GM, Head IT CSV at Sun Pharma
06th October 2020

mAb Industry in China : Biosimilars vs Innovative Biologics

Presented by Dr. Joe X Zhou, CEO at Genor Biopharma, Walvax Bio Group and Sarah (Xuyu) Wang, Head of Segment Marketing, Biosimilars and Bioconjugations at Sartorius Stedim Biotech
09th October 2020

Hybrid Models: The Best of Both (Mechanistic & Empirical) Worlds to Accelerate and De-Risk Process Development

Presented by Christian Airiau, PhD, Global Head Data Sciences, Biologics Development at Sanofi and Chris McCready, Lead Data Scientist at Sartorius Stedim Biotech
12th October 2020

Mapping of PAT Tools for Enabling Integrated DSP in Continuous Biomanufacturing

Presented by Dejan Arzenšek, Principal Scientist at Novartis and Maryann Cuellar, Life Science Product Manager at Kaiser Optical Systems, Inc.
15th October 2020

Viral Safety by Design for Cell and Gene Therapy Products

Presented by Mark Plavsic, Chief Technology Officer at Lysogene
16th October 2020

High-Resolution Optical and Dielectric Methods Monitoring Cells in Bioprocesses

Presented by Michael Butler, PhD, CSO, Cell Technology, National Institute for Bioprocessing Research and Training (NIBRT)
19th October 2020

Establishing Early Development Strategies For Therapeutics Proteins

Presented by Thorsten Lorenz, Head Early Drug Substance Development and Sorina Morar-Mitrica, Principal Fellow Sr Drug Product Lead Early Phase Biologics at Novartis and Renee Tobias, Director of Marketing, Halo Labs
21st October 2020

Considerations on Impact of Raw Material Variability in Gene Therapy Manufacturing: Applying Lessons Learned From Biologics Manufacturing

Presented by Presented by Aaron Mack, Engineer at Biogen and and Greg Stromberg Interim Leader of Global Manufacturing Material Sciences at Biogen,, Dr Lisa Dixon, Acting National Director, Animal Product Import and Export
22nd October 2020

Next Generation Bioprocess Facility Design – A Case Study From Samsung Biologics

Presented by Anthony Newcombe, Senior Director, Samsung Biologics and John Bonham-Carter. Product Line Leader, Cell Culture & Clarification Business, Repligen
26th October 2020

Challenges and Successes in Externalization of the ADC Supply Chain

Presented by Firelli Alonso, Ph.D., Senior Director, External Supply at Pfizer
28th October 2020

Moving the Implementation of Digital Technologies in Pharmaceutical Manufacturing Forward

Presented by Thomas O’Connor, Scientist at FDA, Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech and Chris McCready, Lead Data Scientist at Sartorius
30th October 2020

Analytical Challenges for Gene Therapy

Presented by Clare Blue, Director of Analytical Development at Biogen and Saba Hussein, Applications Manager and Senior Scientist at Virona
03rd November 2020

Designer Sterile Filtration in Aseptic Processing Using Single Use Technology

Presented by Alan Kelly, Project Engineer at Sanofi
04th November 2020

Case Study: Biomanufacturing for Tomorrow

Presented by Marc Pompiati, Principal Scientist at Roche Diagnostics GmbH
05th November 2020

Next Generation Manufacturing at Biogen – PAT as an Enabler for Enhanced Process

Presented by Oliver Steinhof, PAT Scientist at Biogen and Martin Gadsby, Owner, Optimal Industrial Automation Ltd
06th November 2020

Innovation in Biomanufacturing Plants

Presented by Hang Zhou, Ph.D., Vice President, Head of Cell Culture Process Development Biologics and Bioprocess Dept. at WuXi Biologics and John Bonham-Carter. Product Line Leader, Cell Culture & Clarification Business, Repligen
10th November 2020

Smart machine learning solution to master industry 4.0 in biopharma

Presented by Moritz von Stosch, PhD,
11th November 2020

Application of Internet of Things Framework to Laboratory Data

Presented by Shrikant Swaminathan, Senior Engineer at Alkermes
12th November 2020

Think Big, Start Small – Capability Implementation on the Path to Smart Manufacturing within Industry 4.0

Presented by Robert Guenard, Senior Director - Manufacturing Sciences at Biogen, Petter Moree, Global Industry Principal at OSIsoft and Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech
13th November 2020

Real Time Monitoring of Bioprocess and Beyond – A Process Analytical Perspective

Presented by Dhanuka Wasalathanthri, Senior Scientist at Bristol Myers Squibb
16th November 2020

In Depth Characterization with Mass Spectrometry and Orthogonal Methods of Conformers in a Trispecific HIV Antibody

Presented by Bruno Genet, Lab head Structural Analysis MS at Sanofi
18th November 2020

Closed, Automated and Controlled Upstream Processing for iPSC- Derived Cell Therapies

Presented by Mustafa Munye, Lead Scientist at Cell and Gene Therapy Catapult
19th November 2020

Raw Material Sourcing and Qualification

Presented by Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC
23rd November 2020

Process Development & Manufacturing Technologies for Bio-therapeutics and Vaccines

Presented by Atin Tomar, Co-Founder & CEO at Yapan Bio and Nirav Desai, Co-Founder at Yapan Bio
24th November 2020

Improving Efficiency in Upstream Process Development

Presented by Jackie Gonzalez, Senior Upstream Development Engineer at Takeda
24th November 2020

Novel Technologies That Aid the Detection and Differentiation of Proteinaceous Impurities in Biologic Drug Substances and Drug Product

Presented by Danny Chou, President and Founder at Compassion BioSolution, LLC
30th November 2020

Janssen CM-strategy: A Story of Multiple Platforms From R&D to Commercial

Presented by Jeroen Geens, Engineering Technical Director at Janssen Research & Development
03rd December 2020

How can you Best Use Network Analytics and Modelling To Support Digital Engineering In Pharma Manufacturing Operations

Presented by Presented by Gareth Alford, Lead Engineer at GSK
01st February 2021

Continuous Capture and Continuous Recovery – Novel Ideas for Product Recovery from Perfusion Process Using ATF

Presented by Dr. Kerstin Lange, Team Lead Process Technology and Innovation, Advanced Bioprocessing and And Andrew Falconbridge Vice President Process Technology and Innovation, Alvotech
03rd February 2021

Future Trends To Control Risks From Extractables and Leachables

Presented by Jason Creasey, Managing Director at Maven E&L Ltd
09th February 2021