[BLOG] Donor Management for Clinical Products

[BLOG] Donor Management for Clinical Products

Part 2 in AllCells' GMP blog series will look at the importance of the donor recruitment and management process in facilitating high-quality clinical grade isolations
This week, in part two of our GMP blog series, we will look at the importance of the donor recruitment and management process in facilitating high-quality clinical grade isolations.

One of the biggest challenges for cell and therapy developers is the variability in source cells that are the basis for producing advanced therapies. These cells, which can be isolated from human patients or donors, are inherently variable due to individual attributes, health status, treatment history and more. This can add extra complexity to an already challenging development process. Therefore, strategies to mitigate inconsistencies, such as obtaining high-quality, regulatory-complaint starting cells for producing the therapeutic product can go a long way to achieving clinical success.

Having a robust donor network paired with effective donor management is vital to the collection of high-quality cells and makes it easier to find the right donors, with the appropriate clinical parameters, at the right time.

The complexities of recruiting, qualifying, screening donors and navigating the regulatory framework is not trivial. For cell therapy developers, timelines, resources and budgetary constraints may limit their ability to manage the donor aspect of their programs internally. Leveraging the expertise of a qualified and established supplier with a robust donor network and testing protocols can greatly expedite workflows.  

The entire donor qualification process for clinical grade, outlined in Figure 1, underscores the rigorous donor testing to ensure the highest quality bone marrow and leukapheresis collections. After an initial and in-depth screening, all donors undergo a standardised screening process at three-month intervals. Donors are tested against an infectious disease panel prior to donating for research grade cellular products. For clinical grade donations, donors must meet additional, more stringent testing requirements:
  • FDA-mandated 21 CFR 1271 viral screening by Clinical Laboratory Improvement Amendments (CLIA)-approved laboratories in compliance with good tissue practices (GTPs) 30 days and again 7 days prior to donation
  • American Association of Blood Banks (AABB)-derived health history verifications and physical assessments completed by trained medical personnel
Figure 1. The steps to donor qualification for research grade (RG) through to clinical-grade (CG) donation
Once the donor is qualified, the GMP-compliant cell collections are performed using GMP-compliant protocols and are extensively documented to ensure compliance. Prioritising the safety and comfort of our donors during donation is extremely important in success donor management.

To safeguard against costly delays resulting from donor attendance failures, a secondary, back up CG donor is always qualified in parallel with the primary donor to make sure you can get the cells you need, when you need them. If you need specific donor attributes for your application, we can help you identify and customise a pool of recallable donors to ensure supply chain continuity for your workflow.

AllCells manages the largest donor database in the industry with an extensive registry of healthy, IRB-consenting, recallable donors with diverse demographics and backgrounds. Our experience in delivering GMP-compliant clinical-grade products for allogeneic use to customers around the world combined with project management capabilities can be leveraged to streamline and expedite clinical workflows.

Stay tuned for the next installment of this GMP blog series, which will examine the quality framework used for our clinical grade products.
For information on AllCells’ clinical-grade product offerings, please click here