Journal of Vaccines & Vaccination

Analytical methods and biological products

13^th Annual Congress on Vaccines, Therapeutics & Travel Medicine: Influenza & Infectious diseases

December 01-02, 2016 Atlanta, USA

Ali Azizi

Sanofi Pasteur, Canada

Posters & Accepted Abstracts: J Vaccines Vaccin

Abstract:

There is a gap in the knowledge of analytical methods and validation. Many researchers (in particular academic groups) focus on discovery of new biological products without considering the relevant compliance and regulatory guidelines. Therefore, the potential candidate leads nowhere pass the lab bench! Validation of methods is one of the major GMP compliance required by regulatory agencies. Validation of analytical methods during and after process development is necessary to demonstrate that the analytical methods are fit for their intended purpose. All relevant data obtained during validation should be included in the Investigational New Drug (IND) application for clinical trials. One of the main guideline for validation is the International Council for Harmonization (ICH Q2A) which discusses the characteristics that should be considered during validation. This workshop will review and discuss the specific recommendations for validation of analytical procedures.

Biography :

Email: Ali.Azizi@sanofipasteur.com