Cell and Gene Therapy Scale Up Manufacturing Resources
Developers are in search of efficient, low-cost solutions to implement into their scale up manufacturing strategy. While these hurdles are widespread, the industry as a whole is determined to manufacture these life-changing therapies and make them accessible for patients in need. This determination is why we've cultivated the most pertinent resources from our experts on key considerations, innovative technologies, and tips on meeting regulatory requirements in your CGT scaling up processes strategy.
Webinar: Preparing Your Gene or Gene-Modified Cell Therapy for IND Filing
In this webinar our experts discuss the benefits of a full-funnel approach to gene and gene-modified cell therapy development, which will help you meet regulatory requirements from the very beginning, as well as other key considerations.
Webinar: Regulatory and Process Strategies for CGT Drug Products
The second webinar in our Scaling Up for Success Series, experts will discuss the importance of considering regulatory compliance and optimizations during all phases of drug product development, starting with research and discovery through commercialization of your cell and gene therapy.
White Paper: What Sets Cell and Gene Therapy Developers Apart Early-On
In conjunction with Cell and Gene Therapy Review, This article explores the strategies top innovators use to streamline development, reduce costs, and accelerate timelines—without compromising quality or compliance.
Article: Considerations for Successful Scale Up and Viral Vector Purification
The premier issue of the Cell and Gene Therapy Review quarterly publication featured an article written by our own expert, James Cody, Associate Director, Technical Evaluations. This article touches on mitigating risks in scaling up production processes through data-driven process design.
Infographic: Essential Manufacturing Scale-Up Considerations for Cell and Gene Therapies
Designed in conjunction with Bioinsights, this infographic presents lesser-known considerations for scaling up production processes in cell and gene therapy development, such as the use of the feedback loop in early production stages and optimizing genetic engineering.
Frequently Asked Questions (FAQs) About Scale Up Manufacturing
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What is the difference between scale up vs. scale out?
In cell and gene therapy scale up manufacturing, the difference between scale up vs. scale out is that scaling up manufacturing processes involve the use of higher-volume single unit bioreactors or vectors to produce more cells. Alternatively, scale out requires running multiple bioreactors or vessels simultaneously to produce higher throughput. Scale up vs. scale out is simply a means of manufacturing strategy.