Overcoming quality and regulatory challenges to reliably take your cell & gene therapy to commercialization
Sep
15
2022
On demand

Overcoming quality and regulatory challenges to reliably take your cell & gene therapy to commercialization

Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST
Sponsor
Overcoming quality and regulatory challenges to reliably take your cell & gene therapy to commercialization

Cell and Gene Therapies (CGT) hold great promises as potentially curative medical treatments against a variety of difficult to treat diseases. However, major challenges such as scale complexity, high manufacturing cost, starting material variability need to be addressed early on in order to bring your potential life-saving therapies to patients. During this webinar, Lonza's experts will provide insights into key considerations for establishing a de-risked CGT commercialization path.

  • Challenges and opportunities of autologous, allogeneic and viral vectors when considering their unique technical development & manufacturing process
  • Strategies to meet the quality & regulatory requirements of CGTs
  • Lonza's New Product Introduction process (NPI) for CGT manufacturing – how to identify issues early on, reduce quality & compliance risks, and how to avoid delays and rework



Andreas Wirth
Andreas Wirth
Vice President, Global Head of Quality, Lonza

Andreas Wirth is Lonza's Global Head Quality of Cell and Gene Technologies, Personalized Medicine. He has 30 years of experience in the pharmaceutical industry across different functions such as Manufacturing, Quality, Clinical Development and Regulatory Authority.

Christoph Meyer
Christoph Meyer
Senior Director, Global Head Quality Control, Lonza

Christoph Meyer has worked at Lonza since 2021 as Global Head of Quality Control Cell and Gene Technologies. Prior to this, he was at Novartis for 16 years and occupied several leadership roles in the fields of QC, Development, Quality, and Operations. Christoph was awarded a PhD in Analytical Chemistry from University of Tübingen (Germany).

SPEAKERS

Andreas Wirth
Andreas Wirth
Vice President, Global Head of Quality, Lonza
Christoph Meyer
Christoph Meyer
Senior Director, Global Head Quality Control, Lonza

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