Welcome to the new Cell & Gene Therapy eBook Series from Informa Connect Life Sciences. In each interactive ebook in the series, we delve into a crucial area of the industry. In this first edition, we focus on technologies and platforms that are being utilized to solve common obstacles in cell and gene therapy production.
While there is so much demand for drug development in the cell and gene sector, there is a thirst for solutions to achieve scalability while driving down high costs.
In the next pages, we explore which technologies can address the sector’s biggest and most unique challenges across areas such as the use of vectors, AAV quantification and qPCR assays, and the best ways to introduce automation.
Jump to any article using the contents on the following page, or at any time using the Contents menu in the top left. There you can also download this eBook as a PDF.
One of the most sensitive tools related to cellular or gene therapy products for biodistribution and shedding evaluations is quantitative polymerase chain reaction, also known as qPCR. The development and validation of qPCR comes with a unique set of challenges given the high level of analytical method customization required and the absence of specific regulatory guidance. Charles River has developed strategies to help tackle these obstacles as well as for how to implement these assays for successful conduct and completion of nonclinical and/or clinical sample analysis.
In April 2020, we launched a survey into the use of vectors in creating cell and gene therapies, which found responses from industry professionals all over the world. The report reveals the growing opportunities and challenges surrounding viral and non-viral vectors which are ready to be addressed.
With commercial demand for cell and gene therapies now higher than ever, the pressure is on for companies to scale up manufacturing while minimizing cost of goods. Process automation offers many benefits, but not without challenges in areas such as cost and implementation. Yet, what steps are best to take? We asked three industry experts for their best advice.
Rapid and accurate methods for the quantitation of Adeno-associated virus (AAV) particles are an unmet need for advancing bioprocessing in gene therapy. ForteBio has developed a quick, high-throughput and robust AAV2 capsid quantification method, capable of virus titer determination in samples along the purification process.