Meeting report on protein particles and immunogenicity of therapeutic proteins: Filling in the gaps in risk evaluation and mitigation

Biologicals - Tập 38 - Trang 602-611 - 2010
John Carpenter1, Barry Cherney2, Anthony Lubinecki3, Stacey Ma4, Ewa Marszal5, Anthony Mire-Sluis6, Thomas Nikolai7, Jeanne Novak8, Jack Ragheb2, Jan Simak5
1University of Colorado, Boulder, CO, USA
2Division of Therapeutic Proteins, Center for Drugs Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
3Pharmaceutical Development & Manufacturing Sciences, Johnson & Johnson Pharmaceutical R&D, Radnor, PA, USA
4Genentech Inc., South San Francisco, CA, USA.
5Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA
6Amgen Inc., Thousand Oaks, CA USA
7Abbott Laboratories, North Chicago, IL USA
8CBR International Corp, Denver, CO, USA

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Biologicals

Tập 38

602-611

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