Webinar

When does outsourcing autologous collection center qualification and the cell therapy supply chain make sense?

View Webinar The first autologous CAR-T therapy was approved in 2017, and the industry has since gained substantial operating experience, treating tens of thousands of patients globally. Some drug sponsors have developed in-house teams to manage, improve, and maintain the infrastructure needed for these complex therapies, while others have opted to outsource these responsibilities. The…

Webinar

Understanding and leveraging cord blood bank capabilities and practices in cell therapy development

View Webinar 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…

Webinar

Optimizing Access to High-Quality, Standardized and Compliant Leukopaks for the Development and Commercialization of Allogeneic Therapies

View Webinar 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…

UK Review and Recommendations on the Procurement of Starting Materials by Apheresis for ATMP Manufacture

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…

The EBMT/EHA CAR-T Cell Handbook

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…

Webinar

Collection Capacity Impacts from Rapid Growth in Cell & Gene Therapy

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…

Case Study

The Challenge of Multiple Audits and Redundant Training

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…