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

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…

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…

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…

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…

How to Overcome 3 Common Cell Therapy Supply Chain Disruptions

The successful on-time delivery of cell and gene therapies isn’t just good business—it’s a matter of survival for patients. When there’s no room for mistakes, you need an advanced approach to overcome barriers to on-time delivery. In our more than 30 years of experience managing the collection and delivery for time-sensitive cell therapies around the…