CELL AND GENE CONTENT COLLECTIONS
Exclusively for subscribers of Cell and Gene, our content collections bundle articles centered around a particular topic or theme. These carefully curated selections feature content from both our internal team of editors as well as our subject matter experts who contribute regularly to the site.
Key Factors in Designing the Manufacturing Process
Ensuring scalability and efficient timelines in manufacturing while maintaining a reasonable cost is a major component of the cell and gene therapy sector in and of itself. Can the product be manufactured in the quantity and of the quality necessary to meet demand? Are your company’s process development protocols and timelines in order? Have you chosen the right facility to meet your needs, and have you invested in the best possible technology and equipment to ensure scalability? These are just some of the questions we answer for you in our collection of original editorial that caters to cell and gene therapy manufacturing processes.
Novel Research In The Cell And Gene Sector
The novel cell and gene therapies in the development pipeline today are the result of years of pioneering research by world-class, U.S.-based academic universities and biopharmaceutical research companies. Given the number of clinical trials in various stages, the U.S. Food and Drug Administration (FDA) expects that it will receive more than 200 investigational new drug applications a year through 2025.
Navigating The Cell & Gene Sector's Regulatory Landscape
Research and development of cell therapies and gene therapies continue to grow quickly, and regulatory oversight of these therapies is paramount to continued sector success. As such, Cell & Gene has published regulatory advice for sector professionals in the area of novel product development. Indeed, key regulatory tools used to enhance efficiency and expedite the review and approval of applications. For your reference, we’ve compiled this one-stop, data-rich repository of regulatory information — from challenges and the short-term outlook facing the cell and gene sector’s regulatory landscape to analyses of FDA’s recently issued guidances.
Outsourcing Trends For Cell & Gene Therapy
The cell and gene therapy sector’s focus on outsourcing is a major area of on-going concern due to the shortage of suitable manufacturing facilities and qualified outsourcing staff. This collection of original articles from Cell & Gene weighs the economic benefits of outsourcing (i.e. productivity, efficiency, time-to-market, and quality gains) as well as best practices for selecting an outsourcing partner. Here you’ll find information about the current limitations associated with a complicated manufacturing process as well as existing and promising opportunities and developments needed to outsource most — if not all components — of the value chain.
Cell and Gene Therapy Commercialization Considerations
As the cell and gene therapy landscape continues to mature, so too do the intricacies of commercialization. Inside the pages of this free collection of articles, you’ll find insightful data addressing the challenges critical for the sustainability of cell and gene therapy business models.
Rethinking Bioprocess Facility Design
Download this free collection of articles and learn how to let go of legacy aseptic filling line equipment, seven common filling blunders and how to avoid them, nontraditional design concepts for CAR T processing, what to do when your isolator is taking too long to de-gas. Herman and Erich Bozenhardt bring a collective 54 years of bioprocess facility design and production experience to the pages of this comprehensive ebook.