The cord blood banking industry has been around for over 30 years, focusing on acquiring units for use in hematopoietic stem cell transplant. Recent research indicates that cord blood can be a valuable source of naïve cells for cell therapy manufacturing. Cord blood banks are evolving their processes to accommodate the use of cord blood…
Cellular starting material is the most critical component in the allogeneic cell therapy manufacturing process. Ensuring material access while maintaining quality, consistency and regulatory compliance are necessary throughout every stage of clinical development through commercialization. During this webinar, you will learn about: Factors to ensure streamlined access to high-quality, consistent starting material for allogeneic therapies…
To ensure safe, high-quality Advanced Therapy Medicinal Products (ATMPs) are delivered to patients, procurement activities must be standardized when possible. Standardization also supports efficiency and reduces the risk for error while meeting regulatory and accreditation requirements. Download the UK Review and Recommendations on the Procurement of Starting Materials by Apheresis for ATMP Manufacture for insights…
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…
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 maintaining collection capacity to keep up with demand, while ensuring high quality levels. This session focuses on capability and capacity considerations to support these emerging therapies, standardization strategies and…
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…
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…
