Advancing Gene Therapy – A Quality by Design Approach
Speaker: Peiqing Zhang, Strategic Technology Partnership Leader APAC, Pall Corporation
Do you already have a sound Chemistry, Manufacturing and Controls (CMC) strategy to guide your gene therapy development process? In this episode Peiqing Zhang speaks about some of the recent regulatory setbacks for gene therapy programs. He notes that one of the main reasons is gaps in the CMC section of the regulatory submission and that interpretation and implementation of guidelines released for gene therapy seem to be unclear to the industry. Pall recently published a Quality by Design (QbD) framework to tackle the CMC challenges for Adeno-Associated Virus (AAV) products which illustrates the concept and provides initial thoughts on using QbD concepts for gene therapy.
To download the Pall Whitepaper on Quality by Design for Adeno-Associated Virus products as referenced in Peiqing’s video, please click here.
ABOUT PALL CORPORATION
Pall Corporation provides critical filtration, separation and purification solutions to meet the demanding needs of a broad spectrum of life sciences and industrial customers around the globe. Across 80 locations and 10,000 people worldwide, we are unified by a singular drive: to solve our customers’ biggest fluid management challenges. And in doing so advance health, safety and environmentally responsible technologies.
Together, our Life Sciences and Industrial teams serve a diverse range of customers including biotechnology, pharmaceutical, medical, food and beverage, laboratory, microelectronics, aerospace, fuels, petrochemical, chemical, automotive and power generation industries.
Our industry-leading technologies and solutions are at work in countless applications, protecting critical operating assets, improving product quality, safeguarding health, and minimizing emissions and waste.