The field of cell and gene therapy (CGT) is undergoing a significant transformation, with a notable shift towards allogeneic platforms. Placing a spotlight on what has been deemed the ‘future of cell therapy’, the 5th Allogeneic Cell Therapies Summit brought together leading minds to share knowledge with the goal of accelerating the development of safe, durable, and clinically viable off-the-shelf therapies that are affordable and accessible to patients in critical need.
During the summit, AllCells’ Vice President of Donor Operations, Lauren Greene, delivered a thought-provoking presentation on reframing the donor supply chain ecosystem to support the imminent CGT manufacturing boom. This article will delve into the key takeaways on donor characterisation baselines, critical aspects to build a reliable and scalable engaged donor community and why stringent donor selection criteria yield successful programs.
IS THE INDUSTRY READY TO DELIVER?
As an industry, it must be ensured that there is an adequate supply of starting materials to meet the demand fueled by the maturing CGT clinical pipeline and momentum towards allogeneic approaches. It’s easy to forget that this supply comes from people, and the inherent risk of a very variable supply chain needs to be mitigated to meet the manufacturing demands of the future.
To do this, the right donors need to be selected in the first place, then risk mitigated to ensure deliverability and consistency via donor characterisation, smart program planning, and donor management all while understanding how capacity goes hand in hand with donor pool supply volumes to keep donors engaged.
But first, what exactly qualifies a CGT donor?
As Lauren pointed out in her presentation, when talking about donors, this term is used without a firm definition of what that means and not everyone defines a “donor” the same way.
- Is a donor someone who has been HLA-typed but has no history of apheresis collection?
- What about a donor who has had a successful white blood cell collection but whose virals and health questionnaire are >14 months old?
- What about an individual who lives 8 hours from a collection site?
For the industry to scale at the pace of expected therapy approvals, a standard profile of a CGT donor must be established within the FDA 21 CFR 1271 requirements and beyond. This baseline enables AllCells to get researchers the materials they need when they need them.
There also comes a point in CGT development where researchers need to screen or identify donors, so they reach out to suppliers like AllCells and ask, “How big is your donor pool?”. It’s a logical place to start as they try to determine how many resulting donors they will get who fit their study criteria based on either known public demographic statistics or their own study rates, but it’s not just about numbers. As Lauren puts it, “Our job as a provider of cellular starting material from human donors is to change the dialogue and set a new starting point for the donor conversation.”
CRITICAL ASPECTS TO BUILD A RELIABLE, SCALABLE, & ENGAGED DONOR COMMUNITY
As a donor supplier, the primary objective is to establish a reliable, scalable and engaged CGT-focused donor pool that supports the growing needs of the industry. To achieve this, AllCells prioritises donor characterisation above and beyond the minimum clinical 21 CFR 1271 guidelines to minimise the time it takes to identify suitable donors. This includes understanding donor behaviour (lifestyle, routine) and life cycle (age, seasonality) to get a comprehensive profile, which enables AllCells to develop recruitment programs that resonate with donors. Building a successful donor community for CGT comes down to active engagement and donor pools must be designed using models outside of mass recruitment for the sole purpose of achieving a high volume of donors.
Taking inspiration from production and supply planning models, Lauren and her team use similar principles and treat the donor pool as a supply, albeit a highly variable one. This allows AllCells, as the supplier, to establish safety stock volumes that cultivate a high rotation of collections per donor. In other words, when the donor pool volume aligns well with apheresis collection capacity, a highly engaged and dynamic donor population is created. Conversely, a surplus of donors that is disproportional to collection capacity would result in wasted supply and poor engagement.
AllCells’ donor population contains a large core group of donors who are reliable and recallable because they are reassessed every three months to track eligibility and status at any given time point. By consistently engaging and collecting from their core donor pool, AllCells ensures sustained participation and knows that the reliable data is accurate. Donor identification and characterisation are important to maintain a CGT donor pool but reliable data on a donor’s study participation history and routine are equally vital.
While retaining donors is an integral part of the process, it is also necessary to vet and remove inactive/ineligible donors to continuously curate the donor pool and ensure that it can scale to meet the industry’s demands.
WHY STRINGENT DONOR SELECTION CRITERIA YIELD SUCCESSFUL PROGRAMS
“If a successful apheresis product is our end goal, then we must prioritise knowing, first and foremost, whether donors can participate in a quality collection.”
Lauren emphasises the importance of a stringent donor screening process upfront since it directly impacts the overall success of the process. By implementing rigorous and robust screening models, AllCells can ensure that only suitable and qualified donors are included in the pool, thus enhancing the quality and reliability of the end product. Additionally, assessing the donors frequently on top of collections helps identify and eliminate variables that AllCells can control with stringent vetting processes, which fall outside the established clinical criteria for donor selection. For example, what is the donor’s proximity to a donor centre, lifestyle/habits, and does the donor have good veins to support a quality apheresis collection?
Investing in robust donor characterisation efforts is also crucial. This ongoing process provides comprehensive data about donors used to build predictive models that can facilitate faster identification of target donors and reduce lead times. Moreover, by selectively building their donor pool instead of employing an open enrollment or all-comers model, AllCells better aligns the pool with client-specific end goals, ensuring a higher likelihood of success in CGT development and production. But how can it be scaled if the vetting process eliminates donors at this rate?
As Lauren puts it, “To scale, we need to grow awareness for CGT donations to capture a new donor audience— we must establish new brands, create a call to action specifically for prospective CGT donors and appeal to a younger demographic.” AllCells’ solution is LeukoLab™, an in-house brand that utilises Institutional Review Board-approved marketing and recruitment materials that speak directly to the donor. Notably, a positive donor experience and high engagement play pivotal roles in driving a referral-based recruitment program. When donors have a good experience, they are inclined to spread the word about the donation process with others who may not have previously considered CGT donations, which creates a sustainable and diverse donor community that can effectively scale.
Reframing the donor paradigm is a crucial step towards ensuring the future sustainability and scalability of cell and gene therapies. Starting with industry baseline definitions and adopting a multi-disciplinary approach to build effective donor pools, a robust donor ecosystem can be established to meet the evolving needs of the industry, bolstering the availability of high-quality donor materials catered to supporting the imminent CGT boom.
Originally posted by AllCells on https://allcells.com/reframing-the-inherent-donor-supply-chain-ecosystem-to-support-the-imminent-cgt-manufacturing-boom-recap-of-the-allogeneic-cell-therapies-summit-2023/
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