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…

Best practices along the allogeneic product collection pathway

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.…

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 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

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 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…

6 Considerations When Evaluating Cell Sourcing Partners

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…

5 Considerations to Lower Your Risk When Selecting a Supply Chain Partner

As your therapy operations scale from early-phase clinical trials to larger populations in late-stage trials and commercialization, your supply chain complexity—and risk—increases. Anticipating common setbacks and actively planning for their solution requires a specialized and collaborative approach with your supply chain logistics partner. Keep these key considerations top of mind as you evaluate whether potential…