Starting material collection can set the fate of your final cell therapy product. Quality matters. That’s why your site qualification process—including your quality system audit—for each site is so important. But with the rapid proliferation of cell and gene therapies, current processes are unsustainable and could cripple cell collection site capacity. That could mean delays…
As UCLA Health continues to participate in multiple CAR-T and other immunotherapy clinical trials, its apheresis unit and cell therapy lab continue to experience an increase in the need for their cell collection and processing services. Guest author, Heather Steinmetz, MPH, Quality Assurance Manager, UCLA Health Hematologic Malignancy/Stem Cell Transplant Program, shares some of the…
Centers that collection patient cells feel crunch from growing demand. The arrival of CAR-T cancer treatments and the expected coming age of cell therapies are opening new frontiers for what medicines look like: Cells are taken from patients, then tweaked or supercharged in a lab, and finally given back to patients. Read this article to…
On-demand webinar offers actionable insights as you develop your protocols. Many crucial considerations impact a cell and gene therapy developer’s apheresis center selection strategy and ability to efficiently scale processes. When collection processes or protocols differ from those in place at a center, there are likely implications for training, forms and standard operating procedures. This…
The ONE Forum 2021: On-demand session Over the last several years, there has been increasing global investment in the development of novel allogeneic cell and gene therapies. A recent study published by Nature Reviews Drug Discovery estimates that in 2021 over 400 allogeneic cellular therapies are under development across the globe, many of which are…
The ONE Forum 2021: On-demand session As cell and gene therapies continue to progress at a rapid pace, apheresis and collection centers face the challenges of keeping up with demand, while maintaining high-quality levels. This session focuses on capability and capacity considerations to support these emerging therapies, standardization strategies and solutions that can bring efficiencies…
Considerations for developing scalable and efficient collection network processes The decisions you make when selecting apheresis centers to collect source material for your cell or gene therapy impact your ability to efficiently scale your processes. When your processes and protocols differ from those at an apheresis center, delays can occur. Following best practices can help.…
Off-the-shelf cord blood units (CBUs) are a rich source of cells for use in the development of allogeneic cell and gene therapies. However, CBUs with the characteristics you need may be spread across multiple cord blood banks. Understanding which cord blood banks have the CBUs that meet your requirements is a challenge. And qualifying and…
A joint venture between the European Society of Blood and Marrow Transplantation (EBMT) and the European Hematology Association (EHA), the CAR-T Cell Handbook offers clinical care applications for health care professionals in the EU that treat patients with CAR-T cell therapies. Download the guide for insights into many aspects of CAR-T cell therapies including: The…