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BioPharma Product Testing DACH News (in German)

BioPharma Services News

News: 

  • The clock is ticking as the new Annex 1 will enter into force on August 25, 2023. Read here more... 

BioPharma Product Testing Events: 

Medical Device Testing / Consulting Events: Seminare, Webinare und Workshops

 

BioPharma Product Testing

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Eurofins Medical Device Testing Brochure Eurofins Human Safety Testing: Service Overview EU retest and release analysis with QP final release (+Version in German)
Eurofins BioPharma Product Testing D-A-CH Overview Cyber Security Agrochemicals Testing Webshop Reference Standards (+Version in German)
Eurofins BioPharma Product Testing Hamburg Extractables & Leachables Biocides Testing  
Active Ingredients Hemocompatibility Chemicals (REACH) Testing  
Alternative Toxicology Reprocessing Cosmetics Testing  
Bioassay and cGMP Potency Testing Microbiology, physical and chemical quality of production water Food and Feed Testing  
Biopharmaceutical Release Testing Microbiological Tests    
Cell-Based Assays      
Cleaning Validation and Disinfection Efficacy Studies      
Express Analysis      
Extractables & Leachables      
Facility Monitoring and Support      
Flow Cytometry      
Full Time Equivalent Service Model      
Genetic Toxicology      
Golimumab      
Immunoanalytical Services      
Immunogenicity      
Herbals      
Lecithins      
Metals      
Method Development and Validation      
Microbiology Services      
Persistent Organic Pollutants      
Pharmaglycerin      
Product Release Testing for the European Union      
Product Stability Testing and Storage      
Raw Materials and Excepient Testing      
Release and Stability Testing      
Sterile and Non-Sterile Product Testing      
Trace Metals Testing      
USP Residual Solvents      
Quantitative Immunoassays      

 

Our complete instrument list for all testing activities can be downloaded here

Recommendations and considerations for bacteriophage therapy usage in clinical setting
European Pharmaceutical Review, June 2023

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

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

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