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Biosafety Testing Cell and Gene Therapeutics: Regulations, Requirements and Recommendations

  • Location

    Online

  • Start

    15 Jun, 2022

    6:00 AM

  • End

    15 Jun, 2022

    6:00 AM

  • Time Zone

    Bangladesh Standard Time

Register Now

Join our webinar to learn about key requirements and considerations for the biosafety analysis of cell and gene therapeutics.

Introduction

Manufacturers require approval from National Regulatory Authorities to therapeutically use cell and gene therapies, whether for clinical trials or as licensed products. However, prior to use, their freedom from potential adventitious agent contamination must be established.

Such rigorous, clearly defined testing requirements emerged to protect clinical trialists’ and ensure consumer safety. This is to prevent repetitions of historical contamination events. For example, when patients with hemophilia and blood-related conditions were infected with HIV and other blood-borne viruses in the 1970s after receiving treatment using proteins isolated from human plasma.

The adventitious agent tests required today detect contaminating adventitious agents in biopharmaceutical products throughout the pre-clinical, clinical and licensing stages of the product lifecycle.

This webinar will outline current testing strategies for cell and gene therapeutics, focusing on the types of validated assay methods required to detect potential adventitious agents, in compliance with current global regulatory authority requirements.

Objective

This webinar will clarify key requirements and considerations for biosafety analysis of cell and gene therapeutics.

Agenda

  • Introduction to biosafety testing
  • International regulations and guidelines
  • Example testing strategies
  • Cell and gene therapy current and future test methods

Target Audience

This webinar is aimed at development scientists, QC directors and managers, research and development directors and project managers working for life science companies (or other organizations seeking to develop cell and gene therapy products).

Presenters

Dr Richard Adair
Senior Virology Manager

Richard joined SGS in 2007 to focus on the development and GMP validation of cell-based assays for virus detection. For the last 15 years, Richard has been a lead scientist on a wide range of assays, ensuring therapeutics comply with international regulatory bodies’ safety and characterization requirements.

Margaret Temple
Business Development Director

Margaret started her career in the biosafety industry with Q-One Biotech in 1995 before becoming a founding member of the SGS Glasgow site in 2007. She has extensive experience supporting client product development to address biosafety and characterization requirements.

For further information, contact:

Josela Renardson
Global Marketing Manager
t: +44 0 121 541 4748

  • SGS Bangladesh Limited

Noor Tower (2nd, 6th – 10th & 13th Floor),

110, Bir Uttam C R Dutta Road 1205,

Dhaka

Bangladesh