HemaCare is pleased to announce the publication of their latest article  in the current issue of BioProcess International.
The piece, entitled “The Cell Therapy Industry Needs High-Quality Healthy-Donor Material”, gives readers expert insight into the growing demand for cell therapy starting material, and how that demand is impacting suppliers.
One of the key challenges facing the cell and gene therapy (CGT) industry today is the need to ensure reliable sourcing for healthy donor cell therapy starting material. Rapid growth in the number of cell-based therapies in clinical trials and the anticipated steady increase in FDA clinical approvals raises the specter of a potential bottleneck as suppliers struggle to keep up with demand.
The Four Contributors to a High-Quality Donor Database
To prevent such shortages, it is critical that developers have access to both large, diverse donor networks and a supplier with excellent quality oversight.
Donor recruitment can make all the difference when sourcing CGT starting material. Consistent outreach, positive donor interactions, and close attention to donor safety all contribute to a robust network of reliable donors. Ongoing network management assures sourcing demands can easily be met with responsive, well-characterized donors. Proactively identifying back-up donors that match client specifications is a must; having someone standing by in case a donor is unavailable helps ensure project goals are met in a timely manner.
For the last 40 years, HemaCare has focused on building long-term relationships with a demographically diverse donor pool. Donor nurturing and safety are our highest priorities, and crucial to retaining reliable, recallable donors.
Quality control is just as important to securing well-characterized healthy donor material, since downstream therapeutic benefits are directly impacted by starting material quality. Reliable sourcing of high-quality healthy donor starting material will prevent manufacturing delays, ensuring the successful transition of CGT products to mainstream medical practice.
For more insight on HemaCare’s high-quality donors click here.
- Taylor B., and Clarke D. The Cell Therapy Industry Needs High-Quality Healthy-Donor Material. BioProcess International. 17 (11-12). Dec 2019.