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…

Reimbursement uncertainties hinder patient access to CAR-T therapies

The approval of CAR-T therapies Kymriah® and Yescarta® in late 2017 represented an enormous milestone for patients with leukemia, lymphoma, and other blood cancers. However, the ongoing uncertainty over reimbursement has made it difficult for patients to access the CAR-T treatments. Despite the months passed since the therapies were FDA approved, only some patients that…

Stem cell therapy

Cell therapy in 2018: Mid-year review

2018 has been a year of advancement for the cell therapy industry. With the first two approved CAR-T cell therapies now on the market, organizations are shifting their focus from commercialization to industrialization through well-designed supply chains, standardized quality assurance practices and long-term outcomes tracking to support current and future cell therapy products. Let’s take…