As more cell-based therapies transition towards the market, hurdles surrounding safety, efficacy, and manufacturing are becoming increasingly apparent. The advancement of gene delivery technologies is fundamental to driving more clinical prospects of cell therapies.
Liquid biopsy is a noninvasive method used for the diagnosis and monitoring of disease states, including cancer. Instead of physically taking a biopsy of the affected tissue, cell-free DNA (cfDNA), circulating tumor DNA (ctDNA, a subset of cfDNA present only in tumors), or cancer cells in suspension (also known as circulating tumor cells, CTCs) are collected from blood or other fluids.
We describe a Droplet Digital PCR-based method, Drop-Phase, which allows users to quickly and accurately phase genomic variants. We successfully phased pairs of CFTR variants and show the methodology can measure linked species that are up to 210 kb apart. This method can be used to phase variants discovered through sequencing or to screen unsequenced individuals for a particular haplotype of interest for clinical trials.
Your future cleanroom is a critical asset, it is not just another construction project. The investment you make in the cleanroom facility is significant and it should perform for years to come. Learn the relative strengths and weaknesses of various cleanroom construction methodologies that are being implemented within the marketplace.
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 advent of CRISPR as a gene editing tool continues to revolutionize drug discovery and development.
Evaluating how much a process step contributes to viral clearance is an essential part of process validation in order to be sure you are manufacturing safe drugs. Learn more about how HiScale 10/40, packed with MabSelect PrismA, is a reliable choice for the capture step in a virus clearance study.
Integrated single-use freeze-thaw assemblies with reliable component parts, such as the connectors supplied by CPC, have become the primary implementation choice for achieving successful drug substance transfers between manufacturing facilities.
Alternative to water baths for thawing frozen cells
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.
It goes without saying that upgrades during a manufacturing shutdown pose less risk as there are no products being produced, but there are instances when it is critical to expand capacity or modify functionality while maintaining some processing. Following are a steps to help maintain control of production and changes—and demonstrate proof of control—while keeping the involved workers and the products safe.
What's the future of food traceability? Learn more in this free collection of articles highlighting recall prevention, a transparent brand-consumer relationship, and how to choose the right food traceability system.