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Strategic Selection and Development of Immunogenicity Binding Methods - Webinar By ComplianceOnline

 
  May 08, 2012  
     
 
ComplianceOnline, Online Webinar
2012-07-26


Why Should You Attend:-

The principal components of a meaningful immunogenicity program consist of an initial binding screen followed by confirmation and quantitation of the positive samples.

This 90-minute webinar first reviews the technologies and formats currently in use to detect unwanted immunogenicity. These sections will help the scientist to a priori select the appropriate procedures to specifically meet the needs of their product. The second part of the webinar provides a step by step approach to develop a method that will meet the current validation standards regardless of the technology and format that is utilized. Case studies are cited throughout the webinar to demonstrate the impact of the method on immunogenicity results. Finally, a check-list is supplied to ensure that essential requirements are in place to proceed into validation.

Learning Objectives:-

Learn how to select the best technology and format combination to develop a compliant immunogenicity binding method.

Areas Covered in the Seminar:-

  • Regulatory expectations
  • Technology platforms:  Label dependent and label independent Feasibility and timeline
  • Assay formats: Bridging and direct
  • Controls and reagents: Preparation, storage and stability
  • Feasibility Storage of cell banks to certify stability
  • Optimization: MFAT/DOE versus OFAT
  • Pre-validation
  • Check-list for validation

 

 
 
Organized by: ComplianceOnline
Invited Speakers: Dr. Menendez, is currently an international instructor and consultant on GMP/GLP Bioassay and Bioanalytical Method Development and Validation. In her previous position as Senior Director of Biotechnology at Catalent Pharma Solutions she implemented various laboratories to verify the functionality and safety of biotechnology products using cellular, molecular and immunological technologies. Her expertise covers potency bioassays, PK and immunogenicity testing. Her latest industry paper provides recommendations for preparing and storing non-manufacturing cell banks used in GMP and GLP analysis.
 
Deadline for Abstracts: 2012-07-26
 
Registration:
For Registration :-
 
E-mail: referral@complianceonline.com
 
   
 
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