How AllCells’ Expanded Donor Collection Facilities Help You to Recruit the Right Donors and Scale Your Cell and Gene Therapy Development

How AllCells’ Expanded Donor Collection Facilities Help You to Recruit the Right Donors and Scale Your Cell and Gene Therapy Development


How AllCells’ Expanded Donor Collection Facilities Help You to Recruit the Right Donors and Scale Your Cell and Gene Therapy Development

Unlike classical therapeutics (i.e., monoclonal antibodies), the raw starting materials for cell and gene therapies (CGTs) are derived from patient or donor cells. As such, these sources are not mass-produced and are inherently sensitive to supply chain complications. Access to these essential starting materials hinges on donor access, collection facility capacity, processing expertise, distribution networks, and a harmonized quality oversight system.

 

Quality Over Quantity to Recruit the Right Donors

Many CGT developers initially seek a commercial supplier with access to an enormous donor network. Some suppliers overtly boast a network of hundreds of hospitals and medical centers with hundreds of thousands of donors to attract CGT researchers. But there is a significant problem with this model: many suppliers do not operate the physical collection facilities or directly manage the clinical staff. As a result, these disjointed suppliers are introducing significant variability into an already tenuous supply chain.

While having a scalable donor network is still important, it is most important to recruit the right donors — donors with the specific attributes for your given application, who are reliable and recallable to provide a consistent source of biomaterials. All of AllCells’ donor collection facilities and analytical service laboratories operate under a harmonized framework that mitigates variability across locations. Paired with the expertise to recruit donors with specific attributes, AllCells offers access to a large network of highly characterized donors, delivering consistent products to bring your therapies to success.

 

AllCells’ Robust Network of Donor Facilities

For the past 6+ years, AllCells has been the premiere GMP biomaterials supplier with specialized expertise to support the cell and gene therapy sector regionally, domestically, and globally. The opening of AllCells’ recent Houston, Texas facility follows the company’s goals to build increased apheresis capacity and expanded donor access to address growing demand. With a presence already in two major biotechnology hubs (San Francisco Bay Area and Boston Metropolitan Area), the addition of the centrally located Texas facility and our Huntsville, Alabama collection facility from Discovery Life Sciences is integral in providing faster delivery options and increased donor access (Figure 1).

AllCells’ expanding network of FDA-registered, IRB-approved, AABB-compliant facilities work under a cohesive and connected operational and quality system with stringent standards. Clinical staff are highly trained and execute clinical grade collections as part of day-to-day operations in adherence with Good Manufacturing Practices (GMP) standards. Additionally, cell processing and analytical laboratories are adjacently located to the donor collection facilities, allowing starting materials to be isolated and processed immediately to safeguard product quality and meet regulatory requirements for clinical CGT programs.

 

Upcoming Donor Facilities Across the Globe

As the CGT sector continues to diversify and tackle new disease indications, the specific requirements for donors will be a moving target. Now that AllCells and Discovery Life Sciences have ‘joined forces’, our CGT clients will have expanded access to tens of thousands of well-characterized, highly engaged recallable donors from AllCells’ collection sites across the US and Europe. Coupled with expanded capabilities that include integrated analytics, upcoming donor facilities greatly amplifies AllCells’ ability to effectively deliver a robust, scalable, and highly characterized supply chain to CGT developers advancing their therapeutics at any scale with confidence.

The Key to Developing Good Manufacturing Practice (GMP) Biomaterials for Cell and Gene Therapy Development

October 3, 2022


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