Current Issue
Identification of Unknown Extractables and Leachables Using Mass Spectrometry: Identificat...
Petra Booij, Investigator GlaxoSmithKline R&D, Gunnels Wood Road, Stevenage, United Ki...
Hybrid Models for Biopharmaceutical Process Development – Making the Best of Mechanistic...
Shilpa Nargund, Data Scientist & Business Developer Insilico Biotechnology AG, Singapo...
Big Data Strategies for Cell Therapy Manufacturing
Scott R. Burger, MD, Principal Meredith L. Burger, Associate and Technical Writer Advanced...
Biosafety and Safety by Design: Identifying Adventitious Agents in Cell & Gene Therap...
Archie Lovatt, Life Sciences Biosafety Scientific Director SGS
Standardized Protocols for Generating Extractables Data on Filtration and Single Use Syste...
Saskia Haehn, Laboratory Manager for Extractables & Leachables Central Analytics of Me...
Standardizing Single-Use
Hélène Pora, Vice President Technical Communication & Regulatory Strategy Pall Biote...
Featured Articles
Continuous Bioprocessing: PAT Strategies in Support of Process Monitoring and Control to Enable Rapid Product Release
By: Jeffrey Doyle, Manager, PAT Projects in the Process Analytical Sciences Group
Paul Jeffers, Manager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’Neill, Analytical Chemist
Pfizer
Enabling Total Biopharma Solutions
Pall Life Sciences
Continuous processing optimization with smarter tools
Barbara Paldus, Ph.D.
Vice President & General Manager Finesse, part of Thermo Fisher Scientific
Single-Use-Systems: Leachable Study Design for Single-Use Components
Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb
View All Featured ArticlesHeadline News
Construction of First J.POD® Facility in North America Initiated by Just – Evotec Biologics
Phthalate-Free Clearflo® 70 Tubing Introduced by NewAge® Industries
AstraZeneca and Merck Announce US FDA Accept Submission of sNDA for LYNPARZA® (olaparib) and Grants Priority Review
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Upcoming Webinars
High-Resolution Characterization of Structure, Interaction, and Miscibility of Drug Products
Presented by Eric Munson, PhD, Professor and Head at Purdue University
11th February 2020
In Situ High Speed NIR Imaging & Raman Mapping to Monitor Form Change and Drug Release from Rapidly Disintegrating Tablets
Presented by Patrick Wray, Senior Research Investigator at Bristol-Myers Squibb and Miriam Böhmler, Senior Applications Scientist at WITec GmbH
10th March 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
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Past Webinars
Is India Anywhere Closer to Implementing Continuous Bioprocessing
Presented by Narasimha Rao Nedunuri, Managing Director of CLONZ and José Castillo, PhD, CTo and co-founder of Univercells
16th August 2018
Alignment to Standardized Extractables Testing, Facilitating Single-Use Adoption
Presented by Presenter: James Hathcock, Ph.D., Moderator: Hélène Pora, Ph.D.
29th June 2017
Biopharmaceutical process development – Trends/ Challenges/Opportunities
Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and Validation Consulting group at Pall Biotech
20th November 2019
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Featured Companies
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Featured Video
How single-use bioreactors help us prepare for our future?
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Technical Papers
Rationale Design of Valves for Flexible Processing
Push-Button Simplicity: Automatic Fermentation with the BioFlo® 120 Auto Culture Mode
Best Practices for Achieving Virus Safety
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Featured Products
Decrease Cleaning Validation Time and Resources
AdvantaPure
Amsphere™ A3 Protein A Resin – JSR Life Sciences
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