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…
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…
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…
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.…
When patients’ lives rely on a manufactured cell or gene therapy arriving exactly when and where it needs to, it is essential to ensure each step of the critical supply chain is managed as efficiently as possible. Cellular starting material collection is at the beginning of that supply chain, making cell collection processes vital to…
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…
Cell therapy clinical trials—including those for hematopoietic cell transplantation (HCT)—come with unique challenges and complexity that impact the clinical trial sponsor, investigators, clinical trial sites, physicians, and patients and their caregivers. We offer comprehensive clinical trial services for academic and industry investigators and sponsors, as well as patients, because we know saving more lives through…
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…
Off-the-shelf cord blood units (CBUs) are a rich source of cells for use in the development of allogeneic cell and gene therapies. However, CBUs with the characteristics you need may be spread across multiple cord blood banks. Understanding which cord blood banks have the CBUs that meet your requirements is a challenge. And qualifying and…