In cell therapy trials, the ability to track a patient’s cells is essential. When you have over 100 patients, and the cells will require multiple shipments, using a spreadsheet is not possible. “For the safety of our patient, accurate tracking is a must,” says Gerald Garrett, VP of clinical operations for MarkerTherapeutics. “We need to know exactly where the product is at any step of the way.”
The movement of viral vectors, cell therapies and other antibody-based next-generation drug products toward commercialization is driving the need for new and different technologies and facilities. Engineering and design firms with the right skill sets can help you maintain the right balance in your facility design to maintain flexibility which is essential to meet diverse processing needs for biopharmaceutical manufacturing.
This white paper addresses the unique production problems of cell and gene therapy and explains how a manufacturing execution system (MES) can address them. It provides guidance on how to select an MES and a case study of two CAR-T therapy companies scaling up with and without an MES.
This study demonstrates a cell freezing protocol that uses the LN2-free VIA Freeze Quad controlled-rate freezer for the cryopreservation of up to eight cryobags and up to 560 mL total volume.
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.
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.
Studying biology at a single-cell level can provide crucial insights into how individual cells contribute to human biology and disease. Here we demonstrate that the resolution of single-cell RNA sequencing (RNA-Seq) can be greatly enhanced by adding a cell sorting step prior to RNA-Seq analysis.
Digitally enabled cryogenic cold chain technology can now deliver the raw materials needed to manufacture cellular therapies
Cell therapy manufacturing has been a complex, challenging and costly process, but a new manufacturing solution seeks to change that
Purification of enveloped viruses and virus-liked particles presents several challenges due to their large size and complexity. This case study demonstrates resin screening, process development and scale-up purification of a retrovirus-like particle.
Competitive pressure and tight budgets are forcing pharmaceutical and biotech manufacturers to make optimum use of their existing facilities. Cloud-based OEE monitoring provides real-time insights into equipment performance – with quick and easy deployment and expansion, zero maintenance overhead and near-instant ROI.
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.
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