Webinar

International Differences in Cellular Starting Material Quality and Regulatory Requirements

Navigating international differences in regulations for cellular starting material is complex. This is particularly true because the rapid advancement of the industry sometimes precedes regulatory guidance. When you’re procuring cellular starting material or distributing a cell or gene therapy product across international borders, you must consider the country or regional requirements at play and where…

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…

BioTherapies White Paper

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.…

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…