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…

A Cell Therapy Industry Turning Point

Starting material collection can set the fate of your final cell therapy product. Quality matters. That’s why your site qualification process—including your quality system audit—for each site is so important. But with the rapid proliferation of cell and gene therapies, current processes are unsustainable and could cripple cell collection site capacity. That could mean delays…

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…

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…

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…