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…
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…
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…
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…
To identify a sufficient number of donors who meet study eligibility, health authority and medical suitability requirements, a large donor pool is required even for the most common HLA genotypes. Choose a partner whose registry size and diversity are built to scale with you. Discover how accessing the most diverse registry of potential donors in…
When patients’ lives rely on a manufactured cell or gene therapy arriving exactly when and where it needs to, it is essential to ensure each step of the critical supply chain is managed as efficiently as possible. Cellular starting material collection is at the beginning of that supply chain, making cell collection processes vital to…
Human leukocyte antigens (HLAs), which are proteins found on the surface of most human cells, are fundamental to the success of matching potentially life-saving donors with patients in need of a blood stem cell transplant. Immune cells use HLAs to protect one’s own cells from invading microbes and viruses. A properly functioning immune system will…
Sourcing your starting material from healthy, high-quality donors matters when you are manufacturing an allogeneic cell therapy. Any misstep can mean delays in your therapy’s development. Keep these key considerations top of mind as you evaluate whether potential partners have the experience, expertise and relationships required to identify, source and collect your allogeneic donors and…
Orchestrating cell and gene therapy logistics is complex and susceptible to variability at each point of the supply chain. When shipments are life-critical, delays and oversights can be fatal. As operations scale from small populations in early-phase clinical trials to larger populations in late-stage trials and commercial launch, your supply chain complexity and risk increases.…