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Top Ten List of Analytical Inadequacies in IND and BLA Submissions
Alfred Del Grosso
Team Leader, Analytical Chemistry
Regulatory Perspective on Comparability Assessments of Biotechnology Products
Audrey Jia, M.D., Ph.D.
Division of Monoclonal Antibodies
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November 09-10, 2015 · Hyatt Regency Reston · Reston, VA
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Updated: September 15, 2015
AbD Serotec, a Bio-Rad Company
BDS Immunoassay Services
Eurofins Lancaster Laboratories, Inc.
KBI Biopharma, Inc.
KCAS Bioanalytical & Biomarker Services
Pall ForteBio LLC
SQI Diagnostics, Inc.
Thermo Fisher Scientific
Monday, May 4, 20153:15 pm - 6:45 pm
Tuesday, May 5, 201510:00 am - 6:30 pm
Wednesday, May 6, 201510:30 am - 2:00 pm