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Technical Whitepapers

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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