BPI Theater at BIO Digital
Technology Integrators in Cell and Gene Therapy: Increased Efficiency and Standardization
Date: Monday, June 8
Time: 11:05 – 11:25 AM ET
Speaker: Julien Meissonnier, Vice President and Chief Scientific Officer, Catalent
Abstract: The cell and gene therapy markets are seeing growth both in the use of allogeneic and autologous cell therapies as well as viral vectors for gene therapy and ex-vivo transduction of the cell therapies. Both require investments in disruptive technologies to enhance safety and activity as well as reduce production costs. Accelerated clinical trials for advanced therapeutics is on the rise and with many having fast track status designation, it is increasingly critical for innovators to have efficient and scalable production processes. As more programs shift to late-stage clinical development, optimized methodologies like Manufacturing by Design (MbD) and efficient and optimized manufacturing processing work to eliminate industrialization challenges in order to achieve commercial-ready processes. This process excellence combined with technical expertise across a variety of cell types, including emerging iPSC therapies, allow custom development and manufacturing organizations to be well-positioned to support this fast-moving industry.
Catalent’s deep and expansive cell and gene therapy global network is dedicated to evaluating new innovative technologies and process platforms across the entire scale-up and production process to meet the aggressive timelines of the clinical landscape. Focus areas such as improved upstream and downstream processes, enhanced bioanalytic characterization, high-capacity fill and finish platforms optimized for cell therapy batch efficiency, and integrated supply chains help to alleviate manufacturing bottlenecks thereby achieving more optimized and reproducible manufacturing processes.
GPEx Boost: A Novel Approach for High-Expressing CHO Cell Line Engineering
Date: Wednesday, June 10
Time: 11:45 – 12:05 PM ET
Speaker: Gregory Bleck, Ph.D., Global Head of R&D, Biologics, Catalent
Abstract: Pharma companies are always examining ways to increase efficiencies and reduce cost of drug development. While the cost of goods sold (COGS) can be high for small molecule drugs, biologic development can be even more costly due to the complex nature of the molecules. One way to reduce COGS during biologic development and manufacture is to increase the productivity of the cell line that is expressing the protein, typically a monoclonal antibody. Companies have multiple levers they can pull to attempt to increase productivity, but the cell line development process plays an important role in defining the upper limits of production.
GPEx® cell line development technology is a proven technology that generates highly stable, high titer production cell lines. Recently, GPEx technology and a glutamine synthase knock-out CHO cell line were combined in a unique way to create GPEx Boost. The new technology results in higher specific productivities, higher titers, and improved cell growth characteristics compared to GPEx for most protein products. This talk will describe GPEx Boost technology in more detail and discuss additional case study comparisons.