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New York, NY

2-Day Virtual Seminar Method Development and Validation for Assays Supporting Testing of Biologics

Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing. This 2-day seminar is designed to offer a broad overview of developing and validating a range of assay methodologies for biologics with specific key analysis of cell culture, assay variability, and DOE. Specifically, this seminar covers essential concepts related to cell-based potency methods, ELISA, and other methods supporting biologics. In addition to potency methods, this seminar addresses immunogenicity methods for preclinical and clinical studies.\ \ Learning Objectives:\ Understanding the different requirements for small versus large molecules\ Mapping appropriate timelines with decision points\ Designing, developing, optimizing, and validating key methods\ Potency methods, other release and stability methods\ Preclinical and clinical methods\ \ Use of DOE and statistical analysis\ Defining the validation protocol with real-time capture of data analysis
  • Start:September 22, 2021
  • End:September 23, 2021
  • Recurring
  • Where:New York, New York, NY, USA,, New York County, New York, United States, 10018
  • Phone:N/A
  • Event Type: Other
  • Ticket Price:N/A
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