Updated July 29, 2021
Allogeneic cell therapy developers face a challenge as the cell and gene therapy industry grows. How can they meet the future demand for allogeneic donors that allows them to scale their capabilities to reach larger numbers of patients while maintaining consistency?
Some companies suggest the use of a dedicated donor pool as the answer. However, super donors likely aren’t the long-term solution.
“Super donors are an ideal state. If you identify a donor who generates a really good therapy for your product, you would love to go back to them over and over and over again. But they probably aren’t going to be a permanent reliable solution,” said Abby McDonald, PhD, Manager of Solutions Development at Be The Match BioTherapies®.
One simple reason for this is that life circumstances can – and do – change.
“There are so many life events that can influence whether someone is able to donate. They may experience illnesses, relocations or events or make choices that can influence the quality of their donation,” McDonald explained.
Companies that rely too heavily on a small subset of super donors to develop allogeneic therapies introduce an element of risk into their business strategy.
It may seem counterintuitive, but a dedicated donor pool is going to be a less reliable option as time goes on.
“There has to be some level of replenishment. Realistically, donors are going to get a little bit tired of being asked to donate over and over and over again,” McDonald said.
She added, “A few years down the line when your donors are no longer responding to you, you’ll have to start all over again.”
Registry breadth and depth matters as allogeneic cell therapy growth scales
With super donors unlikely to come to the rescue, what should a cell or gene therapy developer look for in a supplier to ensure supply can meet demand? Donor pool size is one key.
“The bigger your pool of potential donors the better it’s going to be in the long run. For example, because of the sheer size of the Be The Match Registry®, our team can identify additional donors through concurrent screening. We can constantly replenish the pool of pre-screened donors that meet a company’s requirements,” McDonald shared.
Additionally, McDonald suggests looking for a supplier with a diverse donor pool. This can become particularly important when a company is developing a therapy with indications predominantly found in certain populations.
“You’ll need to identify somebody who has likely come from that same population themselves,” she said. “Our registry is already the most diverse registry in the world and we’re adding to it on an annual basis. That’s a factor that can be critically important for companies going forward.”
Voluntary donations expand the use of therapies globally
Some companies compensate their donors for their time to help with reliability. That too can introduce an element of long-term risk. This is particularly true for cell and gene therapy companies that seek to market their drug product in more than one country.
Regulations regarding compensation are very clear in certain parts of the world and less clear in others. What is clear is that regulations in some major markets prohibit compensation of donors.
“By compensating donors, you cannot guarantee that the drug therapy made from those cells is going to be usable worldwide,” McDonald explained. “Be The Match BioTherapies takes a conservative approach. We do not compensate donors to ensure the broadest possible use of the eventual therapies.”
Furthermore, if compensation hangs in the balance, donors could be less than forthcoming with their health histories.
“You don’t want to find out five years down the line that cells are unusable because of an undisclosed health event at the time of donation. It could be very detrimental to a cell or gene therapy company,” McDonald cautioned.
Working with a company that does not compensate donors and has a robust quality and regulatory system will help ensure donors are evaluated and collected in a compliant manner.
Allogeneic cell therapy developers play a key role in efficient donor selection
There are also steps cell and gene therapy companies can take to make the donor selection process more efficient. McDonald suggests companies start as broadly as possible with donor requirements.
“The more requirements a company puts in place, the less likely a set of donors will meet all the requirements. The funnel gets narrower and narrower,” she said.
Starting with too many requirements may unnecessarily exclude some donors from moving towards a donation.
“Really identify your absolute needs, your nice to have factors and those factors that don’t matter at all. Weigh how much certain factors may or may not play into the actual manufacturing,” she said.
And finally, McDonald recommends making donor screening as efficient as possible when confirming the donor meets all of your requirements.
“The more steps you have and the more time you have between steps, the more likely it is that a donor will lose interest or engage in risk behaviors. That can make them not eligible to donate,” she said. “Set up the screening activities in a way that doesn’t result in ‘lost time’ for the donors while they wait to hear their results.”
Be The Match BioTherapies helps cell and gene therapy companies lower their risk
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