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HemaCare’s Super Donors to the Rescue!

Mar 17, 2021 10:25:00 AM / by Nancy Andon, MSc

AdobeStock_105698440-1New webinar highlights the benefits of “dedicated donor pools” - the latest offering from HemaCare to accelerate successful cell therapy research and commercialization

HemaCare, through Charles River Labs, recently hosted an educational webinar focused on their latest cell and gene therapy-related service.

HemaCare will now be working with clients to establish “dedicated donor” pools. The purpose of this new program is to establish and maintain a pool of reliable, recallable donors with client-determined physiological and/or demographic characteristics that match specific client research projects and programs.

The cell and gene therapy industry is currently enjoying a period of remarkable growth, a trend that industry leaders and market analysts forecast will continue throughout the next decade. This exceptional growth is welcome, yet at the same time presents supply chain challenges that must be solved so that these treatments can successfully be brought to market.

In the new webinar, HemaCare’s Kimberly Negrin elucidates just how much of a game-changer cell-based gene therapy is to modern medicine. Within the next decade, doctors and scientists may well be able to cure many serious diseases for which there is currently no meaningful treatment. Cell therapies currently in clinical trial represent just a small fraction of the number the industry is on track to develop within the next decade. This revolutionary change will necessitate significant expansion of reliable donor supply networks to meet pharmaceutical demand.

In response to this anticipated demand, HemaCare is rolling out an innovative program designed to expand donor access while significantly reducing time and resource output for pharmaceutical developers.

Access to a large, diverse donor pool is one of the key requirements for successful cell therapy development. [1] This is what enables researchers to find donors that match the specific criteria needed to drive drug discovery and product development forward in a timely manner. When a cell Picture1therapy drug reaches the commercial manufacturing stage, donor starting material supply must be substantially scaled up to match anticipated patient demand and then maintained at sufficient levels to avoid any supply shortfalls. Because these are life-saving medicines, long-term supply chain reliability is of the utmost importance.

Donor recruitment is resource-intensive and time consuming, especially when pharmaceutical customers need to impose project-specific criteria. All potential donors need to be characterized regarding general health, blood type, HLA type, BMI, donor demographic, nutrition and health habits, and the presence of any infectious disease. For safety’s sake, some screens are repeated at the time of donation, and the client may request additional screening criteria to determine the donor’s eligibility for a specific project. All of this consumes time and resources and restricts the number of donors who will qualify for a specific project.

HemaCare has the industry’s largest pool of “super donors”. These are the type of donors clients repeatedly request for their programs. They are reliable, responsive to outreach, and make regular donations. They have good nutrition and exercise habits, and generally have some trait, such as high yield or target cell count, which makes their donation particularly valuable. These “super donors” form the foundation of the dedicated donor program.

Dedicated donor pools provide a highly efficient way for pharmaceutical companies to decrease starting material variability (Fig.1) and to reserve donors with project-specific physiological and demographic traits. Starting material variability is one of the primary concerns of the cell therapy industry because raw material input directly impacts output in terms of viable cell numbers, cell subtype ratios, and target cell functionality.

Picture2Figure 1. Dedicated super donors help compensate for starting material variability. Representative data from a HemaCare donor showing T cell profiles over 5 repeat donations.

Using recallable super donors to source starting material helps compensate for that variability because donors are already well-characterized and target cell profiles are largely identical from collection-to-collection. In fact, when webinar attendees were asked in a live poll what they considered the most important factor to look for in a donor network, the #1 answer was “recallability”.

By reserving reliable, recallable super donors to a specific pharmaceutical project or program, clients ensure their criteria can be met when needed for their project. Dedicated donor pools are managed such that clients can pre-determine the number of donors they will need to fill a particular project pool. Donor screening and recruitment is substantially less frequent than it would otherwise be and takes place “off-screen” if a particular donor becomes ineligible for a project. Cell and tissue collection can be scheduled according to the client’s requirements at a given time and scaled up at need.

At HemaCare, we believe that consistent, reliable starting material is critical to successful cell therapy commercialization. Through our dedicated donor program, we provide our clients with the high-quality starting material they need, when they need it. To learn more about our commitment to a thriving donor network, please visit our website.

Reference:

  1. Clarke D., et al. Ensuring source material consistency and continuity for commercialization of advanced therapies. Cell and Gene Therapy Insights. 6(2), 295–305. 2020.

Topics: Gene Therapy, Cell Therapy Manufacturing, GMP Cellular Therapeutics

Nancy Andon, MSc

Written by Nancy Andon, MSc

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