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...



Headline News

ANDA Approval received by Glenmark Pharmaceuticals for Deferasirox Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg


Large-Scale Oligonucleotide Manufacturing Facility Opened by WuXi STA


Pfizer’s Novel Clinical Stage Asset with Application in Alzheimer’s Disease and Parkinson’s Disease to be Acquired by Biogen


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Upcoming Webinars

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


Strategies to Overcome Low Endotoxin Recovery Using the Conventional LAL Assay

Presented by Dr. Ruth Daniels, Senior Scientist - Microbiology Expert at Janssen
28th September 2020


Identification of unknown extractables and leachables using mass spectrometry: Identification with confidence?

Presented by Petra Booij, Investigator at GlaxoSmithKline and Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific
30th January 2020


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Past Webinars

DSF and FTIR as complementary methods for the identification and characterization of vaccine products

Presented by Marina Kirkitadze, Deputy Director, Head of Biophysics & Conformation Unit, Analytical R&D Biochemistry, Sanofi Pasteur and Rina Dukor, President, BioTools
18th September 2018


Regulatory Approval of Three Rapid Microbiological Methods for MACI Product Release

Presented by John Duguid Senior Director, Research & Development at Vericel Corporation and Nicola Reid, Senior Product Manager at Charles River
08th November 2018


Key components of a comprehensive program for the management of single use technologies in biologics manufacturing

Presented by John Maguire, Shire and Donald Young, ThermoFisher Scientific
18th July 2018


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