Dedicated blood donors, cell therapies
Cell & Gene Therapy
Daniel Klein

Dedicated Donor Pools:  A Foundation for Cell Therapy Development

The treatments of the future rely on the cells, tissues and fluids donated today

Cutting edge medical research into cell and gene therapies have the potential to revolutionize medical treatment over the next few decades. These therapies involve using living human cells and are potentially capable of treating multiple diseases and conditions— many of which currently have no treatment options available. Initial experimental results in the field have been extremely compelling — cancer remission rates over 80%, to name one. However, while some of these treatments use the patient’s own cultured cells, the area of greatest interest is in universal allogeneic therapies using the cellular and biological material of donors. As the supply of usable, reliable cellular material is a major limitation, research organizations and pharmaceutical companies are reaching out to cell suppliers with proven track records of success in donor management — capable of nurturing ongoing donor relationships and establishing pools of dedicated donors.

Jordan Hunter, a product manager at HemaCare, a Charles River company, explains that these donor pools are not only critical during development, but “it's also how you're going to sustain the production of that therapy, and commercialize it, and scale it out so you can reach the largest number of patients... without the [human-derived] material, there is no therapy.” Thus, the impetus is on companies like HemaCare to provide stable, sufficient and comprehensive supplies of donated cells, fluids, and tissues to research and pharmaceutical concerns. One benefit for the clients, explains Hunter, is the high degree of specificity that can be obtained when working with donor populations at scale. The ability to filter by blood type, BMI, age, gender, or any number of other factors is key to the value that large dedicated donor pools can offer, allowing organizations to be highly selective about the cells used while simultaneously insulating themselves from dependency on a small number of volunteer donors.

Keeping the donor pools diverse and active, however, is a full-time job. Recruitment is constant, as there are safety standards and limitations to how often people may donate, and a continuous churn with regards to people’s schedules and lives. And it doesn’t end there, as maintaining the donor relationship is just as critical,
whether it be transportation to the collection facilities, giving regularly scheduled follow-up calls, nutritional advice, or just friendly interaction and appreciation. “These are humans, not mice that we can pull out of a cage by their tail to donate on demand,” quips Kimberly Negrin, an associate director of cell therapy at HemaCare. “Our recruitment team runs a seven-day operation.”

The need to ‘buffer’ — keeping extra supply and backups for the needs of manufacturers is critical. Difficulties can arise at any point: “We never know if a donor is going to be able to donate until they present themselves to the donor site and are screened… if they’re dehydrated, if they have a low iron affecting their red blood cell count, if their white blood cell count is elevated… there are a lot of things that can trigger a donor to not be able to donate.” With some of the turnaround times from donation to delivery as low as 24 hours, “we always have a backup scheduled on the day of donation to ensure collection success,” says Negrin.

The needs of cell therapy developers are great

The challenges facing cell suppliers and tissue banks are only going to grow. The bioproduction demand for allogeneic therapies is projected to increase “fifteen to twenty-fold in the next five years,” says Negrin. Problems are also quick to arise in fulfilling complicated orders with very specific populations: “It’s not that we can’t find the donors, it’s that it might take six months to find the donors.” In the extreme case of O negative blood type, you’re already looking at just 5% of the population. “But then you add in male or female, which cuts it in half, and various viruses they must be negative for… and you could be looking for a unicorn — 1% of the population or less.”

Cell supply organizations are critically important; without them, cell therapies cannot be developed, and treatments cannot be delivered to patients. It is this key fact that informs the entire supply chain. While Negrin says that getting products to patients is what wakes her up in the morning, that attitude is visible throughout the entire organization. Ultimately, says Hunter, “donors really do it for altruistic reasons, to make an impact, and to be a part of the development of something that is going to save another person's life.”

The need for donors is great. Please donate.