Apheresis collection of source material for an allogeneic cell therapy is a complicated process with many variables that can impact product quality. That makes apheresis center selection one of the most important decisions you can make as a cell and gene developer. It is key to establishing a high-quality collection network that can grow, scale and evolve to meet both clinical and commercial needs.
To maximize quality and scalability throughout the supply chain, you must think through collection processes early, select centers that can meet the requirements, and leverage existing apheresis center processes and expertise.
Develop scalable collection processes and protocol requirements
Evaluating steps along the product collection pathway can help you develop scalable collection protocol requirements. Some considerations along this pathway include:
- Donor assessment: Apheresis centers typically use similar donor assessment standards. At this point, think about if your needs may differ.
For example, do you need to include specific information in the health history screening questionnaire to ensure donor suitability for your protocol?Are certain physical exam data points required for compliance with regulatory bodies?
- Day-of-collection donor testing: Identify your pre-collection donor testing requirements and the most efficient way to obtain those samples to minimize the number of required blood draws (each skin break increases infection risk for the donor).
Also, think about your timeline for receiving the results. If CBC results are needed prior to collection start or leukopakpack out, an apheresis center that cannot complete a CBC on site may not be the best center to collect for your protocol.
- Apheresis equipment: While the Spectra Optia is the apheresis device most apheresis centers use, some use devices such as the Amicus. The devices may have different capabilities that could benefit your starting material. If you do not have specific requirements around the apheresis device, you may have more centers to select from to add to your network.
- Processed blood volume: Donor processed blood volume is a key parameter used to aid apheresis collections. Be sure to account for the cells lost during the manufacturing process as you determine the volume target needed during collection to achieve the desired cell count. If it does not impact product quality, consider allowing centers to process following their own internal guidelines
- Anticoagulants: Think early on if there are specific anticoagulant requirements for your cellular source material or if centers can follow their own institutional procedures. For example, if heparin negatively impacts manufacturing and the center’s internal process is to automatically add heparin, you’ll need to ensure the center can adjust their process to participate in the protocol.
- Concurrent autologous plasma: Concurrent plasma is believed to serve as a buffering agent to help maintain cell viability, especially if a product will be shipped fresh a long distance. However, it could also dilute your cells. If your manufacturing facility is in the same country, is it more beneficial to have the highest cell count possible? These decisions can also impact the centers you select if you prefer the apheresis center is close to the manufacturing facility.
- Product volume target: Product volume targets allow the apheresis operator to gauge processing volumes. Product volume targets have implications on materials used during collection, such as the leukopak size, materials used for processing and shipment, and downstream processing.
- Post-collection processing requirements: Remember that apheresis centers have validated institutional SOPs for post-processing steps, like cryopreservation. These processes have been developed from the center’s extensive collection expertise.
If you have specific requirements for post-collection processing that will impact your manufacturing in any way, they are obviously needed. However, if you do not have restrictions, centers will perform best if you allow them to follow their own internal processes and procedures.
Understand what each apheresis center can and cannot deliver
Once you have developed your protocol requirements, you can use those requirements to assess an apheresis center’s capabilities at each step of the product collection pathway.
Ask yourself questions like:
- Can the center deliver on all our required specifications?
- Does the center have cryopreservation capabilities?
- Does the center have the capacity to meet our collection timeframes and volumes?
- Are there shipping lanes between the apheresis center and manufacturing facility that allow the source material to be delivered in the required timeframe?
Remember, no two apheresis centers are exactly alike. Capabilities and skillsets between centers differ. Select the apheresis centers that can meet your protocol requirements and grow with you as you scale.
Leverage existing apheresis center processes and expertise when possible
You can increase the likelihood of higher product quality and fewer quality incidents by minimally impacting an apheresis center’s existing processes.
A deviation from a validated institutional procedure may require revisions to the center’s SOPs, validation of the new procedure prior to use, and staff training on the protocol-specific steps. This can all impact the time to first collection.
Leveraging a center’s expertise and existing processes is the most efficient path forward if those processes will not impact your final product.
Consider working with an existing collection network
A vendor with an existing collection network works with the apheresis centers day in and day out and truly understands each center’s capabilities.
Using Be The Match BioTherapies as an example, we leverage our experience with our collection network partners to help create best practices and processes to get cell therapy protocols up and running as quickly and efficiently as possible. We examine a sponsor’s must-haves versus nice-to-haves and determine which centers may be best suited to collect for the protocol.
In addition, we have geographic diversity within our collection network. Having a large, geographically diverse network has allowed us to adapt and be flexible throughout the COVID-19 pandemic. We could shift collections at the height of the pandemic as hotspots moved around the nation in waves. As a result, we had minimal disruptions in our collections as we moved through 2020 and 2021.
Remember, many crucial considerations will impact your center selection strategy and your ability to efficiently scale your processes. Think through your process early to maximize quality and scalability throughout your supply chain and leverage existing expertise for efficient protocol implementation.
About the author
Lacey Anderson, Senior Manager, Collection Network Management, Be The Match BioTherapies
Lacey Anderson is the Senior Manager of Collection Network Management for Be The Match BioTherapies. She and her teamwork to develop and manage the Be The Match BioTherapies Collection Network for cell and gene therapies in clinical trials, interfacing between collection centers and cell and gene therapy developers. Anderson joined Be The Match BioTherapies in August 2019, bringing with her more than 10 years of experience working in apheresis centers. She has held positions in center operations and quality management, as well as donor care supervision.