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 DoyleManager, PAT Projects in the Process Analytical Sciences Group
Paul JeffersManager, PAT Projects in Process Analytical Sciences Group, Global Technology Services
Seamus O’NeillAnalytical Chemist

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

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Headline 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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