Decoding raw material quality and regulatory standards in cell and gene therapy
This webinar will explore the common misconceptions and key considerations for selecting critical raw materials used in the production of cell and gene therapies.
Raw materials are critical to manufacturing cell and gene therapies. As such, manufacturers spend tremendous effort qualifying raw materials for GMP manufacturing to ensure product efficacy. Selecting the wrong raw materials can slow development timelines, increase validation and comparability study costs, and risk patient safety.
The regulatory landscape for cell and gene therapies is rapidly evolving and clear guidelines on raw materials across global regulatory agencies remain unaligned. What are the requirements for raw materials and what strategies can developers use to ensure the success of their cell and gene therapy programs? Join regulatory and quality experts from Sartorius to learn more in this webinar.
What will you learn?
- Explore common misconceptions when selecting critical raw materials
- Understand the regulatory landscape and how its ongoing changes affect your
process - Learn the key requirements for raw materials that will ensure a therapy’s success
Who this may interest?
- Regulatory affairs/compliance managers
- Quality assurance managers
- Process developers/engineers
- Early-stage scientists
- Individuals in manufacturing roles
Speakers
Claire Wartel
Director of Regulatory Affairs
Sartorius-Polyplus (Illkirch-Graffenstaden, France)
Claire has a PhD in molecular pharmacology and pharmacochemistry from the University of Strasbourg (France). After several post-doctoral positions, Claire joined Polyplus (Illkirch-Graffenstaden, France) in 2004 as a Cell Biology Project Leader and helped develop the company’s flagship product, jetPRIME® transfection reagent. Today, Claire manages the Department of Regulatory Affairs at Sartorius-Polyplus.
Julie Hibbert
Head of Regulatory Affairs
Sartorius-Albumedix Limited (Nottingham, UK)
Julie has a Master of Science in Industrial Pharmaceutical Sciences from The University of Manchester (UK) and a Post Graduate Diploma in Regulatory Affairs from the University of Wales (UK). She has nearly 30 years of experience in the pharmaceutical industry, with 10 years as a Research and Development Formulation Scientist working on small molecule drug products before moving into Regulatory Affairs. Julie joined Albumedix Ltd (Nottingham, UK) in 2023 as Head of Regulatory Affairs and nowadays manages the Regulatory Department at Sartorius-Albumedix Limited.
Jürgen Branke
Head of Quality Management
Sartorius CellGenix GmbH (Freiburg im Breisgau, Germany)
Jürgen Branke leads Quality Management at Sartorius CellGenix, overseeing quality assurance, control, regulatory affairs and facility management. With extensive experience in the pharmaceutical industry, he has held key roles at BioChem (Karlsruhe, Germany), Ratiopharm (Ulm, Germany), and Tecan (Männedorf, Switzerland). Jürgen holds a PhD in micro- and molecular biology and a diploma in chemistry from the University of Ulm (Germany).
Ravid Grimberg
Head of Regulatory CGT & Cell Culture Media
Sartorius (Göttingen, Germany)
Ravid Grimberg joined Sartorius in 2019 as Head of Quality Assurance and Regulatory Affairs for Advanced Therapies and was later appointed to focus on the regulatory affairs-related aspects of CGT and cell culture media. In her work, she navigates regulatory topics with a proactive approach and works closely with customers to guide them through the regulatory aspects and requirements of development.
In association with
Recorded October 30 2024