Effect of rapid cell therapy growth on collection capacity

The rapid growth of the cell and gene therapy industry is a positive for patients. However, it comes with increasing demand for high-quality cellular source material collected at apheresis centers. Managing collection capacity impacts from this growth requires understanding challenges from the perspective of the apheresis center and collaboration across the industry to develop solutions.

Creating scalable cell therapy collection processes

As a cell and gene therapy developer, your cell collection protocol requirements and specifications will impact your apheresis center network selection strategy and your ability to efficiently scale your processes. Any time your protocols or processes differ from those in place at a center, there are likely implications for training, forms and standard operating procedures (SOPs), which can delay your first collection.

Industry stakeholders propose unified CAR T toxicity grading scale

Chimeric antigen receptor (CAR) T cell therapies and other new immune effector cell therapies are offering hope for many patients with relapsed and refractory leukemia, lymphoma and other blood cancers. However, these therapies also have known serious side effects, including cytokine release syndrome (CRS) and immune effector cell neurotoxicity syndrome (ICANS). Because the definitions and…

Efficiencies gained from the Quality System Audit Program

Three things to know about efficient qualification of collection centers

Ensuring cell collection centers and cell therapy labs are meeting FDA regulatory requirements and providing high-quality starting material for your cell or gene therapy is critical to your therapy’s success. As the industry continues to rapidly advance, it is becoming more critical to integrate process efficiencies wherever possible. There is a solution: using an established…