Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the US, an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Isreal.
Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology they concurrently evaluate whether or not to manufacture the therapies onsite. Here is a guideline of how and when to get started.
The coming years will be an exciting era in genetic research as we discover new biological mechanisms and functions for noncoding RNAs. Our improved understanding of this class of genes should provide insight into novel treatments for cancers.
Single use technologies are expected to play a big role in the commercialization of cell and gene therapies because of their cost, speed, and sterility benefits.
Freezing cells without liquid nitrogen
Helpful tips such as carefully choosing the most suitable fixative and permeabilization reagents as well as other factors that should be considered when designing intracellular flow experiments.
The availability of commercial multiplex cytokine assays enables end users to interrogate an entire network of cytokines in a single sample.
Challenges of T cell immunotherapies include the costly manufacturing process relying on lengthy and complex open workflows with high manual labor requirements that influence product variability. This application note describes the details of a robust CAR T cell manufacturing workflow that can be adapted for cGMP compliance in commercial production of CAR T cells.
A demonstration of a simple workflow to verify the reliability of the S3e Cell Sorter in sorting single
cells. Using this method, a confirmed sorting accuracies of >94% and 100% for single cells and single beads is achieved, respectively.
Single use connection technologies are expected to play a critical role in commercial manufacturing of cell and gene therapies. Learn about the types of connection technologies and selection considerations.
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