Technical Whitepapers
The Value of Human Panel Testing Downstream of Donor Screening in the Allogenic Therapy Pipeline
Mark Yulis, Ph.D., Senior Scientist, Eurofins BioPharma Product Testing
Compliance with Annex 1: Sterile Fill Finish for Early Phase Clinical Supplies
Joe Page, Ph. D., President of Eurofins BioPharma Product Testing San Diego
Rapid Mycoplasma Testing Service Delivers Speed, Sensitivity and Specificity to a Broad Scope of Sample Matrices
Dr. Weihong Wang, manager, Molecular & Cell Biology Services and Jonathan Demick, principle scientist, Mycoplasma Services
Cleaning Validations: Alternatives for monitoring non-soluble compounds
Dr. Thomas Lehman and Eric Lingenfelter, Method Development & Validation
The Challenge of Detecting Nitrosamines & Mutagenic Impurities
Harley E. Wilcox, MBA, CMC Small Molecule Senior Scientific Advisor and Eurofins BPT Nitrosamine Task Force
A risk-based approach to extractable and leachable evaluations of in-process materials
Davide Tartaglione, Senior Consultant, Eurofins BioPharma Product Testing Italy
Managing your Radiolabeled Supply Chain in Pharmaceutical Radiosynthesis Life Cycle
Harley E. Wilcox, CMC Small Molecule Senior Scientific Advisor
Residual Solvents: Alternative Validated Methods
Nathan T. Whitford, Director, and Danielle Newton, Scientific Group Leader III
Intact Mass Analysis of Therapeutic Proteins
John Snyder, Research Fellow
Extractable and Leachables Studies: designed and performed to meet all intended needs
Thomas Lehman, Ph.D., Director, Method Development and Validation and Extractables and Leachables
Planning the Execution of a Viral Clearance Study
Doug Rea, Research Fellow
Managing Cell Based Potency Assays – From Development to Lifecycle Maintenance
Dr. Weihong Wang, Manager of Molecular and Cell Biology
Compounds Relative Response Factor, a Reliable Quantification Within Extractable Testing
Marco Giulio Rozio, Antonio Rosato, Lucia Iadarola and Simone Carrara
Outsourcing and Insourcing: How Eurofins solves the bio/pharma industry’s challenges associated with meeting drug development timelines and budgets with restricted headcounts
Carolyn Hoppe, Eurofins PSS Insourcing Solutions
Exhaustive Extraction: Definition Of Standardized Conditions For Extractables Testing
Michele Vasso and Simone Carrara, Eurofins BioPharma Product Testing Italy
The Impacts of Brexit on the Bio/Pharmaceutical Industry
Marina Efremova, Business Development Manager
Ten Things You Should Know Before Contracting a Custom Synthesis Project
James M. Schmidt, Senior Scientific Advisor
Developing a Phase-Appropriate Extractables & Leachables Program
Wayland Rushing, Ph.D., Director of Scientific Affairs
cGMP Radiosynthesis for Early Phase Clinical Trials: A Unique Challenge and Development of a Standard Process
Wayland Rushing, Ph.D. and Kevin Roberson Ph.D.
Implementing Extractables & Leachables into Quality Control Testing Programs
Wayland Rushing, Ph.D., Director of Scientific Affairs
How to Evaluate Manufacturer-Provided Extractable Information
Wayland Rushing, Ph.D., Kevin Roberson Ph.D., and Allan R. Moorman, Ph.D.
Development and Validation of a Polysorbate 20 Assay in a Therapeutic Antibody Formulation by RP-HPLC and Charged Aerosol Detector (CAD)
Rowel Tobias, Alan Leslie, William Hanshaw, Paul Lightner, Glenn Petrie and Mike Whalon
Validation of a Dual Wavelength Size Exclusion HPLC Method with Improved Sensitivity to Detect Aggregates of a Monoclonal Antibody Biotherapeutic
J. Tompkins, T. Spurgeon and R. Tobias
The ABC’s of Reference Standard Management
Harley E. Wilcox, MBA, Small Molecule Senior Scientific Advisor
A Cell-Based Assay to Assess the Binding Activity of the Monoclonal Antibody Component of an Antibody Drug Conjugate
Angela Kirik, Mike Whalon, Glenn Petrie, Loretta Sukhu
Bacterial Identification Database
Arnaud Carlotti, President, Eurofins IDmyk