Published Articles
Industry recommendations for phase appropriate approach for assay validation in Cell and Gene Therapies (CGTs)
©BioPhorum Operations Group Ltd
Contributing Authors:
Berangere Tissot
Srividya Ramanathan
Weihong Wang
Navigating Challenges in Cell Therapy Potency Assays
BioPharm International, January 2024
Author:
Weihong Wang, Technology Development Director
Challenging applications of capillary electrophoresis in biopharmaceutical analysis
European Pharmaceutical Review, December 2023
Author:
Giuseppe Peddio and Federica Bisceglia
A Proposal to Align Release Standards for Transfection Reagents
©BioPhorum Operations Group Ltd, November 2023
Facility Tour: Eurofins BioPharma Product Testing - Columbia, MO
American Pharmaceutical Review, Sept/Oct 2023
Mapping the future of DNA/RNA drug products: theory, therapy and testing
European Biopharmaceutical Review, Autumn 2023, pages 28-31X. © Samedan Ltd
Author:
John H Stockley, Principal Scientist
Defining the required critical quality attributes (CQAs) and phase requirements for mRNA/LNP product development and manufacture
©BioPhorum Operations Group Ltd, July 2023
Author:
Heather Bridwell
Contributing Authors:
Brian Barrows
Randy Nielson
New Challenges in Impurity Profiling: Focus on Unknown Impurities and Nitrosamines Recommendations and Considerations for Bacteriophage Therapy Usage in Clinical Settings
European Biopharmaceutical Review, June 2023, pages 8-11 © Samedan Ltd
Authors:
Benedetta Riva, Project Leader
Flavia Favini, Chemical Lab Manager
Matteo Galbiati, Lab Manager
Recommendations and Considerations for Bacteriophage Therapy Usage in Clinical Settings
European Pharmaceutical Review, June 2023
Author:
Snehit Satish Mhatre, Senior Scientific Director of Microbiome, Eurofins BPT
Investing in the Future of Biopharmaceuticals - In San Diego, CA, Eurofins BioPharma Product Testing Offers a Complete Range of Services
American Pharmaceutical Review, May/June 2023
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Putting Customers First
Drug Development & Delivery, June 2023
Contributing Author:
Joe Page, President, Eurofins BioPharma Product Testing San Diego
BioPhorum Raw Materials: A proposal to align release standards for endonucleases used in nucleic acid removal
©BioPhorum Operations Group Ltd, May 2023
Contributing Author:
Andrew Schaefer, Manager - Analytical Method Development & Validation
Contract Testing Services Solidify Their Place in the Manufacturing Value Chain
Pharmaceutical Technology, April 2023, pages 42-44
Interviewee
Stanley Prince, Director of Biosafety & Cell/Gene Therapy Strategy
Combination Products: A Difficult Balance Between Drug and Device
European Biopharmaceutical Review, January 2023, pages 42-45. © Samedan Ltd
Author
Paolo Pescio, Senior Scientific Director
Complex Analytical Workflows Increasingly Require Robust Bioassays
BioPharm International, January 2023
Contributing Author
Weihong Wang, PhD, Director of Technology Development
ATMP and Cell and Gene Therapy Testing Services for the Global Market
American Pharmaceutical Review, November/December 2022
Whole genome sequencing and analysis of live biotherapeutic products
European Pharmaceutical Review, Volume 27, Issue 06
Authors
Michael Timm, Director of Sales and Business Development
Snehit Satish Mhatre, Senior Scientific Director
The challenge of handling highly potent API and ADCs in analytical chemistry
European Pharmaceutical Review, Volume 27, Issue 03, June 2022
Authors
Elodie Barrau, Business Unit Manager
Olivia Jones, Analytical Validation Manager
BioPhorum Raw Materials: Cell and Gene Therapy Critical Starting Material - Further Discussion on Plasmids to Establish Release Specifications Using a Risk-Based Approach to Manage Supply
©BioPhorum Operations Group Ltd, May 2022
Contributing Author
Andrew Schaefer, Manager - Analytical Method Development & Validation
Challenges of quality control potency bioassays
European Pharmaceutical Review, Volume 27, Issue 03
Authors
Dr. Giulia Mancini, Lab Manager of Bioassay Testing
Dr. Alexander Knorre, Senior Scientific Director Biologics & Bioassays
Growing to Serve: Eurofins' Portage, Michigan, Facility Expands to Offer New Capabilities and Services
American Pharmaceutical Review, May/June 2022
Combining Gene Editing and Haematopoietic Stem Cells Gene Therapy Toward Clinical Translation
This article is taken from European Biopharmaceutical Review July 2022, pages 24-28. © Samedan Ltd
Authors
Marian McKee, PhD, Vice President of BioSafety Testing
Giulia Rovaris, Laboratory Manager
Claudia Benati, Senior Scientific Director
Giulia Mancini, PhD, LAB Manager
Automating Aseptic Processing Reduces Contamination Risk
Pharmaceutical Technology, June 2022
Interviewee
Kenneth Laderman, PhD, Manufacturing Director
Mycoplasma Testing in an Ever-Changing World
American Pharmaceutical Review, March 2022
Authors
Christopher C. Smith, Manager Mycoplasma Services
Jonathan M. Demick, Ph.D., Principal Scientist
Pressure Decay: The Container Closure Integrity Testing for Biologic Drugs
This article is taken from European Biopharmaceutical Review April 2022, pages 42-47. © Samedan Ltd
Author
Salvatore Savino, Ph.D., Package Testing Laboratory Manager
An Interview with Kenneth Laderman, Ph.D.
American Pharmaceutical Review, January/February 2022
Interviewee
Kenneth Laderman, Ph.D., Director of Manufacturing
Adaptability of CDMOs Sorely Tested by COVID-19
Genetic Engineering & Biotechnology News, June 2021
Interviewee
Michael J. McDowell, Executive Vice President, Business Development and Project Management
The challenge of quality control for adenovirus and RNA-based vaccines
published in European Pharmaceutical Review Issue 2 2021
Authors
Claudia Benati, Senior Scientific Director
Dr. Anke McCartney, Global Key Account Manager
Autologous, Allogenic CAR T, and the New Frontiers of CAR NK Immunotherapy Products
This article is taken from European Biopharmaceutical Review April 2021, pages 8 – 12. © Samedan Ltd.
Authors
Claudia Benati, Senior Scientific Director
Giulia Mancini, Project Leader
Stanley Prince, Biologics Senior Scientific Advisor
Dr. Marian McKee, Vice President of BioSafety Testing
Frederic Girard, Managing Director
Safety Testing for C&G Therapy Products
This article is taken from European Biopharmaceutical Review January 2021, pages 22 – 27. © Samedan Ltd.
Authors
Claudia Benati, Senior Scientific Director
Liesbeth Hameetman, Head of Microbial Safety Department
Luca Benedan, Project Leader
Giulia Rovaris, Project Leader
Mary Davd, Senior Scientist
Dr. Jonathan Demick, Principal Scientist
Archived Articles