home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Meetings and Conferences
Search
 
 

Method Development and Validation for Assays Supporting Testing of Biologics

  
  May 20, 2021
Others
  
     
 
ComplianceOnline, Virtual Training Through WebEx
24/6/21

DAY 01(9:00 AM TO 5:00 PM EDT)
  • Session Start Time: 10:00 AM
  • Overview of Biologics and Biotechnology
  • Differences between small molecule and large molecule therapeutics
  • Assays required for biologics
  • Timelines
  • Regulatory guidances
  • GxP in biologics
  • Analytical CMC methods and bioassays
  • Assays supporting product development, release, and stability
  • Portfolio of required assays
  • Mechanism of action and potency methods
  • Selection of potency-indicating method(s)
  • Assay formats/platforms
  • Consideration of reagents, endpoints, signal to background
  • Standardizing cell culture procedures
  • Understanding and managing assay variability
  • Overview of feasibility to validation
  • Early development – feasibility
  • Use of DOE
  • Involvement of statisticians
  • Development and final development
  • Optimizing the assays
  • Validation of cell-based methods
DAY 02(9:00 AM TO 5:00 PM EDT)
  • Assays supporting preclinical and clinical studies
  • Regulatory guidances
  • Assay platforms
  • Reagents, endpoints, signal to background
  • Method development
  • Assessing matrix effects
  • Method optimization
  • Validation parameters
  • Incurred sample reanalysis
  • Immunogenicity methods
    • Screening methods
    • Confirmatory methods
    • Neutralizing antibody methods
  • Biomarker validation
  • Written procedures (methods, protocols, SOPs)
  • Analyst training
  • Maintaining quality in-house and in outsourcing
  
 
Organized by: ComplianceOnline
Invited Speakers:

Gwen Wise-Blackman, Ph.D., has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals. She is currently Principal Consultant at Gwen Wise-Blackman Consulting. Her career focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.
 
Deadline for Abstracts: 24/6/21
 
Registration:
$1,699*
(Seminar for One Registration)
June 24-25, 2021, Virtual Seminar

Register now and save $300 (Actual Price: $1,999)
E-mail: referral@complianceonline.com
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.